Community Clinical Investigators

Welcome to the Clinical Investigators Forum

ASCO Research Resources — Tue, 30 Aug 2011 20:39:17 GMT

This interactive interview series presents advice and “lessons learned” from experienced investigators to help physicians interested in research consider the advantages and disadvantages of community-based clinical research. As part of ASCO’s continuing commitment to clinical trials, the series highlights investigators at sites that won a prestigious Conquer Cancer Foundation of ASCO Clinical Trials Participation Award (CTPA).

We hope you will use this webpage to ask questions of the interviewees and add your comments about conducting community-based research.

August 2012 Featured Interview
Grant Seeger, MD, talks about integrating research into community based practice at Altru Cancer Center in Grand Forks, North Dakota. He invites your questions and comments.

May 2012 Featured Interview
Gamini Soori, MD, talks about his experience as Principal Investigator of the NCI-funded Missouri Valley Cancer Consortium Community Clinical Oncology Program (CCOP). He invites your questions and comments.

April 2012 Featured Interview
Patrick Maguire, MD, shares advice about conducting radiation oncology clinical trials and talks about his experience as a Principal Investigator on an NCI-funded Cancer Disparities Research Grant. He invites your questions and comments.

March 2012 Featured Interview
Robin Zon, MD, FACP, talks about the rewards and challenges of establishing a Community Clinical Oncology Program (CCOP) in the Michiana area and sees an exciting future for clinical research in the community setting. She invites your questions and comments.

February 2012 Featured Interview
Brian Issell, MD, discusses the importance of collaboration in developing a Minority-Based Community Clinical Oncology Program (MB-CCOP) in Hawaii. He also speaks about the unique opportunity to work with Hawaii’s diverse population. He invites your questions and comments.

December 2011 Featured Interview
Alan Lyss, MD, provides advice for investigators interested in applying for a Community Clinical Oncology Program (CCOP) grant from the National Cancer Institute. He invites your questions and comments.

November 2011 Featured Interview
David Waterhouse, MD, discusses his experience as a community-based clinical investigator and why clinical research should be viewed as more than just the “jimmies on the ice cream cone.” He invites your questions and comments.

October 2011 Featured Interview
Gary Cohen, MD, FACP, talks about how community-based research offers the benefits of both academia and private practice settings. Dr. Cohen also discusses his strategy for becoming a leader in the field of oncology. He invites your questions and comments.

September 2011 Featured Interview
Nicholas Petrelli, MD, talks about his experience building a clinical and translational powerhouse after 22 years in academia and also provides advice for young investigators interested in building a career. He invites your questions and comments.

View ASCO’s Other Resources Related to Community-Based Clinical Research:

Dr. Grant Seeger Interview

ASCO Research Resources — Mon, 20 Aug 2012 20:25:07 GMT


	Grant R. Seeger, MD

Grant R. Seeger, MD, is a Radiation Oncologist at Altru Cancer Center in Grand Forks, North Dakota, which is a 2012 Clinical Trials Participation Award (CTPA)-wining site. He is the site principal investigator for the Alliance research group.

What was your fellowship experience and how did that translate into you becoming a community-based investigator?
I did a standard radiation oncology residency at the University of Texas Medical Branch, Galveston, and we were and RTOG research site. I was always interested in participating in large randomized multi-institutional trials, because that is how the best evidence-based medicine in generated. I felt that I should be able to offer those new protocols to patients in rural areas and help the data be valid for all patient types.

Your practice won a CTPA this year. When/how did your practice decide to incorporate research into its core activities? Do you have advice for oncologists who are interested in expanding their practice to include research?
We have been doing research at Altru Cancer Center for many years. The name of the institution has changed, but our research group was one of the founding members of the NCCTG based out of Mayo Clinic in 1977. I have been involved with research at Altru Cancer Center since mid-2009.

My advice for other oncologists is that including research requires an experienced team of oncology research nurses and research staff. The process cannot be done by a physician alone. There must be dedicated staff for all of the paperwork and organization of the process. One way to start this process is to visit a similar sized site and find out how many staff they have and what their responsibilities are. Then mimicking and optimizing that system is a good way to start smooth. There is a steep learning curve for those starting a brand new oncology research program. Once the pieces are in place and the staff know their responsibilities, it gels nicely. The process must be coordinated closely with the larger sponsoring research group, such as the Alliance, to meet all of the requirements.

How is research incorporated into your practice today?
We select protocols that we think fit our typical patient mix. We aim to open large randomized phase III trials that have high accrual number goals. We also open a variety of protocols for as many unique disease sites as possible. We have staff dedicated to screening research patients. We want to give every patient an opportunity to participate in a clinical research trial if they are a candidate. All of our medical and radiation oncologists participate in the research process.

How do you talk with your patients about clinical trials?
We screen them for eligibility first and then bring up the option in participating in a trial when we discuss treatment recommendations at the end of a clinic visit. We provide them with a summary of the schema and also a protocol consent to review at their leisure. Then we communicate with them via telephone or at their next visit to see if they are interested in participating. We take time to answer all of their questions related to the protocol and explain the randomization process in detail. We spend a lot of time with each patient and family to make sure they understand the protocol and the extra requirements, such as blood work and quality of life surveys.

What was the best piece of advice ever given to you?
I am not sure if this advice was "given" to me, but what I tell other students is that you need to choose a career that you will enjoy long-term. That is how I function and why I chose radiation oncology. The integration of cutting-edge technology and clinical patient relationships has been perfect for me. I enjoy my job and I enjoy helping improve cancer patients' lives. If you don't enjoy your primary career, you won't be satisfied in life.

What professional development activities would you suggest for early-career investigators?
For undergraduate and medical students, I advise that they get involved with clinical research projects as soon as possible. This could be in a clinical setting, such as a chart review with a mentor, or in a lab setting at a university. There are many university sponsored summer research programs that are also great. For those that are finishing residency or just starting practice, I think that getting involved with a large research group to obtain mentorship and share ideas is a great place to start. If they are in an academic setting, the process of research development is already in process. If they are in a community-based setting, then I think that the benefit is greatest when being involved with research groups, such as the Alliance for clinical trials in oncology. There are many scholarships and research fellowships that are available for young oncologists to enhance their early-career research efforts.

What advice would you give to early-career investigators?
I would advise early-career investigators to apply for a scholarship or grant award if they already have a good research idea or protocol created. I would advise that they seek out a good mentor with experience in research for guidance. I would recommend that they get involved with their regional large research group, such as the Alliance, as soon as possible. Don't quit if the protocol is rejected. Do more research and modify the protocol and re-submit. Or collaborate with groups that are proposing similar projects.

Your Input Needed

ASCO Research Resources — Fri, 20 Jul 2012 19:21:35 GMT

The interview series in the Clinical Investigators Forum has aimed to help physicians interested in research consider the advantages and disadvantages of community-based clinical research. We need your feedback on new topics and questions you’d like future interviewees to address. Please leave your suggestions below or email them to ResearchPolicy@asco.org.

Dr. Gamini Soori Interview

ASCO Research Resources — Tue, 29 May 2012 22:21:22 GMT


	Gamini Soori, MD, MBA, FACP, FRCP, CPE

Gamini Soori, MD, MBA, FACP, FRCP, CPE, is vice-president of Nebraska Cancer Specialists and medical director of the Alegent Bergan Mercy Cancer Center in Omaha, Nebraska. He is also a Clinical Professor of Medicine at the Creighton University School of Medicine, Principal Investigator of the NCI-Funded Missouri Valley Cancer Consortium Community Clinical Oncology Program (CCOP), Member of the American Medical Association Council on Long Range Planning and Development, and member of the Council on Graduate Medical Education (COGME) of the United States Department of Health and Human Services (HHS).

How did you get started as a community-based clinical investigator?
Research is in my DNA. It is what drove me to oncology. I did my oncology fellowship training at the University of Wisconsin School of Medicine-Madison and also spent some time at the Royal Marsden Hospital and Institute of Cancer Research in London, England. My research at the time focused on acute leukemia and 5-FU, which seems like a long time ago now. After training I joined the Wisconsin Oncology Group and also became involved in the North Central Cancer Treatment Group (NCCTG) and the Eastern Cooperative Oncology Group (ECOG).

When I came to Omaha there was no organized mechanism for me to conduct trials. Two colleagues and I got together to create our own infrastructure. We later became one of the first 14 NCI-funded Community Clinical Oncology Programs (CCOPs) and now there are 49 CCOPs.

What advice would you give to early career investigators interested in clinical research?
The path for an academic investigator is relatively straightforward because research is routine and even obligatory in that setting. For someone interested in community-based research I would recommend they affiliate with an academic institution. Many faculty member affiliates are not required to teach but still have access to the academic resources for research. The first thing I did when I came to Omaha was to get involved in Dr. Henry Lynch’s Department at Creighton University. Through this and other collaborations, I was able to start phase I, II and III clinical trials in various areas of oncology.

I would also recommend that a new investigator affiliate with a CCOP. These networks can cross state borders, so oncologists even in remote areas can participate in clinical trials. Another option is for an investigator to create his/her own research enterprise. This is difficult to do but not impossible. In the past, one could get funding support from the industry for conducting investigator-initiated trials. This is becoming harder and harder to do now. The present opportunity in industry trials is to become a study-site of a larger industry-sponsored clinical trial.

What has been your experience as the principal investigator of the Missouri Valley Cancer Consortium CCOP?
Being a CCOP principal investigator is a demanding responsibility that requires many hours of work, but is also extremely rewarding. I typically spend on average, up to 6-8 hours of uncompensated time each week on CCOP activities. But I receive great personal reward knowing that the work we do helps change the standard of care. Just recently, I spent two full days auditing NCI clinical trials at two out of state research sites, all of which was uncompensated time. It is critical that we strive for excellence in the quality of clinical research and maintain the highest standards for conducting clinical trials.

A CCOP is a business entity and we need to perform and deliver. Because NCI funding does not cover the full costs of the research enterprise, we are obligated to find collateral funding from the community. We solicit and foster support from hospital partners but this is becoming more difficult in the current economy. This will unfortunately threaten the number of accruals to NCI trials.

Why should early career investigators seek affiliation with a CCOP?
The CCOP system is very successful. It works because of the enthusiasm of community oncologists and their sense of altruism. It has to get in to your “DNA” or you won’t stick with it. About 75% of NCI-funded cancer clinical trial enrollment comes from the community. Therefore, the CCOP mechanism has a vast impact on the discovery of new and practice-altering treatment advances. Affiliation with a CCOP and active participation in clinical trials is extremely rewarding professionally.

You are a member of the U.S. Department of Health and Human Services (HHS) Council on Graduate Medical Education (COGME). What is the biggest challenge medical schools need to address?
Only 2% of patients with cancer participate in clinical trials. Imagine if we could double that? There is a huge need for the public to take responsibility and we must bring the issue of inadequate patient participation in clinical trials into the public arena. It needs to be articulated at the highest level and brought into the national dialogue.

Parallel to that, training in clinical research is integral during fellowship training and even during the medical school years and residency. If less than 100% of oncologists participate in clinical trials, I believe there is room for improvement. Research should be inherent to an oncologist’s professional role and we owe it to our patients, to advance the practice of cancer care. I view clinical research as taking care of both today’s patients and tomorrow’s.

What other advice would you like to share with fellows and early-career investigators interested in community-based oncology research?
A young investigator needs to keep the clinical research know-how going. Don’t let the daily grind blight that after you complete your fellowship and go in to practice. Make affiliations promptly, so you can keep your hand in clinical research. If you stay involved, you won’t have to find yourself relearning it in 10 years. Never let the passion of clinical research go away.

Dr. Patrick Maguire Interview

ASCO Research Resources — Mon, 02 Apr 2012 14:26:15 GMT


	Patrick Maguire, MD

Patrick Maguire, MD, is a board certified radiation oncologist at the Coastal Carolina Radiation Oncology Center in Wilmington, North Carolina. Dr. Maguire is also the Principal Investigator on a National Cancer Institute (NCI)-funded Cancer Disparities Research Grant

Please tell us more about conducting radiation oncology clinical trials in a community setting. How did you get started? What is unique about this specialty area?

Dr. Maguire: Radiation oncology clinical trials represent a minority of the cancer trials being conducted. Our site got started in 2004 when we were awarded an NCI Cancer Disparities research grant with the goal of improving the outcomes of underserved patients in North Carolina. This grant pushed us to open radiation trials with an eye toward making sure underserved populations were represented.

To someone just starting out, I’d recommend they initially focus on one or two disease sites. For example, our initial focus was on prostate cancer and, thanks in large part to my partner Dr. Mike Papagikos, and our research staff, we continued building our portfolio until we had a trial available to just about every patient we treated for prostate cancer.

What types of trial sponsors do you work with?

Dr. Maguire: We primarily conduct NCI Cooperative Group trials. Industry trials are a possibility, and better financially, but we find the NCI trials more scientifically interesting. The majority of our trials are sponsored by the Radiation Therapy Oncology Group (RTOG). We also conduct trials with our colleagues in gynecological and medical oncology through the Gynecological Oncology Group (GOG) and the Cancer and Leukemia Group B (CALGB), respectively.

What advice would you give to early career investigators interested in clinical research?

Dr. Maguire: Research can be more challenging in private practice than in academics. I would recommend choosing a practice where the mindset is pro-research. It’s helpful to be around like-minded colleagues. It might make financial sense to conduct industry trials for some groups, unless you’re willing (as my colleagues and I are) to run “in the red” with predominantly cooperative group trials.

How can fellows and early-career investigators get involved in community-based radiation oncology research?

Dr. Maguire: I would recommend that radiation oncologists get involved in RTOG. I’d also encourage them to search the NCI website for opportunities. There are plenty of grant opportunities geared to our patient population. Radiation oncologists should be pursuing these opportunities just as much as our colleagues in medical oncology do.

You have been a principal investigator on several trials. What is that experience like?

Dr. Maguire: Having a strong mentor is key. I’d recommend collaborating with someone in academics if possible. The divide between cancer specialists in university and private practice settings is one that can and should be overcome for the best chance of long-term success. Inertia is the biggest hurdle. It’s easier to keep things going once you get started.

How do you collaborate with other investigators and/or research sites?

Dr. Maguire: We have affiliations with the University of North Carolina (UNC) and Wake Forest. These partnerships are a two-way street. There needs to be symbiosis, give-and-take. For example, Wake Forest is a NCI-designated Community Clinical Oncology Program (CCOP) research base. They provide us with selection of cancer control and symptom management trials that are not readily available to us via other channels. We conduct some combined trials with Wake Forest in which there is a principal investigator from each site.

Through our partnership with UNC, they provide mentorship but we contribute experience from the community. For example, we recently designed and implemented a trial for patients with advanced head and neck cancer in the community that our colleagues at UNC decided to open for patients at the university.

Do you have any concluding remarks?

Dr. Maguire: Collaboration is the key to success. It is very hard to carry a radiation oncology research program without multidisciplinary relationships. It’s also beneficial to ensure that the hospital administration understands the benefits of clinical trials for patients and for the institution.

Dr. Robin Zon Interview

ASCO Research Resources — Wed, 07 Mar 2012 05:34:10 GMT


	Robin Zon, MD, FACP

Robin Zon, MD, FACP, is the Principle Investigator of the Northern Indiana Cancer Research Consortium Community Clinical Oncology Program (NICRC-CCOP) and Vice President at Michiana Hematology-Oncology, P.C. Before beginning her medical career, Dr. Zon worked as a pharmaceutical research investigator and manager of medical diagnostic product research and development at Merrell-Dow Pharmaceutical Company and Boehringer Mannheim Diagnostic Company.

When did you become interested in clinical research?

Dr. Zon: I have been interested in oncology as long as I can remember, even before I went into medical school. I was intrigued by the disease process, the therapies and treatments being developed, and by all the work that needed to be done in order to help individuals with cancer. Early in my career I worked in industry doing both bench and translational research, and eventually worked for a diagnostic company. I was involved in research at a couple of different levels in the pharmaceutical world and I really loved research. At one point I considered an MD/PhD and a career in academia doing mostly research but I found that I just loved taking care of patients, so for me the best integration of my passions and interests was to do clinical research in the community setting.

Was your interest in the community setting a challenge during your training?

Dr. Zon: No, not really. I had great mentors through Indiana University School of Medicine Oncology Fellowship Program. They were very involved with the Hosier Oncology Group, which was one of the initial collaborative research programs involving an academic institution and community doctors. There was already a matriculation between the academic centers and the community centers and a culture that fostered delivering research to the community setting and getting patients referred back to the academic center for earlier trials. There was a general excitement that somebody wanted to go out into the community and do clinical research. I think that the academic center would have been encouraging of my career path whether it was going to be in the academic setting or the community setting.

What was the best advice you received during your training?

Dr. Zon: The best advice I got in terms of developing a program was to be willing to reach out to other groups in order to broaden your array of programs.

Another piece of advice was to network with colleagues across the country who are interested in research and learn from each other. ASCO offered a workshop for community oncologists and has continued to help clinicians doing research by offering the Clinical Trials Participation Award. ASCO also makes awards like the Community Oncology Research Grant to acknowledge good research and help clinicians develop better research programs. An important part of these programs is networking, looking to best practices models, sharing best practice models, and disseminating that information so all can share.

I have been lucky to be part of ASCO’s clinical research committee where I was involved in the development of the exemplary attributes paper and putting together the exemplary attributes series in the Journal of Oncology Practice. It’s all about sharing, it’s all about learning from each other, the good and the bad, and trying to problem solve.

What inspired you to apply for a Community Clinical Oncology Program (CCOP) grant and how did you go about doing it?

Dr. Zon: One of the primary reasons I moved to South Bend was that they were already doing research in the community setting. They were well-established as a high accruer in community research through the Hosier Oncology Group (HOG) and the partners I was joining in Michiana Oncology were very interested in research. We decided to try to develop the program as a private practice group, because that’s where this research was being done. We were encouraged by several Cooperative Groups who were familiar with the work that we were doing. We first developed a consortium and had an open invitation to any hospital institution in the whole Michiana area, which includes lower Michigan and northern Indiana. Four hospital institutions elected to participate and once the consortium was established they helped provide the funding for the infrastructure to apply for a CCOP grant. Our CCOP is an NCI granted program under the umbrella of the NICRC. We were established as a consortium in the Michiana area in 1999 and were first granted a CCOP in the year 2000.

We were interested in expanding clinical research opportunities to a much wider audience than what our group could engage on our own, but it was also a way to expand our services to other communities using clinical research as the entrance point into other geographic locations.

Does your institution and patient population find the CCOP participation valuable?

Dr. Zon: Absolutely. By enrolling in a CCOP and becoming a member of the CTSU, we are able to offer a much broader menu of clinical research trials. Not only are we serving the most common cancers, but multiple stages within the cancers and multiple lines of therapy, especially for those with advanced disease. We are also able to offer clinical trials for diseases that are less common. Our patients are very interested in that because we are able to offer trials that they would ordinarily have travel around the country to get. They are also excited because our recognition by the NCI as, for lack of a better word, an “official” research program lent quite a bit of credibility to the research program.

CCOP participation helped our host institutions and the NICRC on a couple of levels. First, it helped accelerate accrual to clinical research studies so that they could receive the American College of Surgeons (ACOS) certification for being an oncology community institution more readily. Prior to that, some centers and community hospitals were able to get ACOS certification by counting folks who went outside their system to enroll on clinical trials. Now they’re able to count the folks who are within their system. In addition, it provided hospitals with a mechanism to raise money for their oncology foundations, so being involved with an NCI designated research program is a marketing tool as well.

What was the biggest challenge in setting up the CCOP?

Dr. Zon: There are different ways a community site can participate in research but the challenges are similar.

The first thing was developing the infrastructure; qualified data managers and well trained clinical research nurses who are dedicated to doing research who aren’t dividing time with patient care in the infusion center of a private practice group are important. In fact, if full-time dedication is not encouraged or required, research will always be a second priority for the nurses.

Another challenge was funding. Nobody expects when you’re doing clinical research in the community setting to make money. We do it because it’s in the best interests of our patients and we’re dedicated to improving oncology care. Funding can come from NCI-sponsored clinical trials and other NCI sources balanced with pharmaceutical studies. The NCI studies do not provide enough funding to cover the cost of the patient on the trial and long term follow up.

The third challenge was engaging the physicians and getting the physician-investigators to be willing to offer clinical trials to their patients and take the extra step to enroll them. Even though many research programs make it as easy as possible for an investigator to enroll a patient we still find that one of the major reasons patients don’t participate in clinical trials is the investigators never tell them about the opportunity. Even within our CCOP, while we do have 100% participation, there are clearly some physicians who are more assertive and aggressive in finding clinical trials for their patients. If you’re starting a program you need to know that you have the dedication of your physicians otherwise it will be very difficult to have the program be successful.

The fourth challenge was and still is the increasing amount of insurance denials for clinical trial participation. It is often overlooked but it is a real problem. We have been able to track a horrendous increase in insurance denials for clinical research participation over the last two years, especially after the health care reform was announced by President Obama. This was just a minor challenge 11 years ago when we applied to become a CCOP, but it is now a primary challenge. So if you’re setting up a research program, it’s important to know who your payors are in your region and whether they will reimburse for clinical trials.

The last challenge was patient perception. Sometimes I forget about that now because we’ve done such a good job of marketing in our area. The patients now come in asking about clinical research. Back in the day, that was a very foreign and frightening option for patients. I still think this is the case for some areas of the country, especially if they’re not doing clinical research routinely. The good news is that the patient advocate groups across the country have been doing a great job getting the word out that the only way advances are made is through participation in clinical research. In fact, the Senate just passed a resolution to proclaim May as Clinical Research Month and our own research program’s annual meeting will highlight how patients have benefited from clinical research.

What advice would you give to new investigators who are considering community based clinical research?

Dr. Zon: When you are interviewing I would recommend that you ask the group if they are conducting clinical research, what their capacity is, what the infrastructure is like, what the budget is, and what opportunities are there to be an investigator and even a lead investigator or leader of the organization in the future. I would encourage you to ask a lot of questions about the practice model, how does it encourage clinical research, does it allow you time away from the office if you decide to be involved at a more leadership level, do clinical researchers attend research based meetings? Understanding the culture of the group that you’re joining and the culture of the region that you’re joining is important. Some communities are more culture-rich than others when it comes to advocating for and supporting clinical research.

What do you see is the future of clinical research in the community setting?

Dr. Zon: I have a sense that there are folks at the NCI who are committed to making certain that research continues to be done in a community setting because that’s where the patients are. It’s important that the community oncologists continue to increase their engagement in order to offer clinical research. What is exciting about research going forward is that it will become more discriminatory when it comes to treating diseases—there is going to be a better selection process for offering the right clinical research to patients. I’m excited for my patients because I may give them better help them in a more efficient manner because of all the advances that are being made. There are some real issues—I mentioned earlier the reimbursement issue and that absolutely must be resolved, and there are others. The future does hold some unique challenges but I believe they are surmountable as long as we meet them head on.

Dr. Zon completed her undergraduate studies in chemistry at the University of Detroit and obtained her medical degree at Indiana University School of Medicine. She performed her residency at St. Vincent Hospital and Health Care Center and her oncology/hematology fellowship at Indiana University, where she was Chief Fellow. Dr. Zon's interests include the conduct of clinical research in various communities, quality care, and survivorship issues.

Affordability of cancer drugs and Radiotherapy, win-win scientific approaches

Ahmed Elzawawy — Thu, 16 Feb 2012 00:05:40 GMT

I am glad to forward to colleagues my chapter entitled "Science and Affordability of Cancer Drugs and Radiotherapy in the World - Win-Win Scenarios" in the book “Advances in Cancer Management”, that has been just published online on 27^th January, 2012, with free online access: .

http://www.intechopen.com/articles/show/title/science-and-affordability-of-cancer-drugs-and-radiotherapy-in-the-world

Nothing is prefect or complete. All has the opportunity to explore and lead their win-win initiative. It is very needed!. This would be the real achievement.

Also, I would be glad if you have a look to http://www.icedoc.org/winwin.htm and I and looking to your kind feedback and comments , Sincerely, Ahmed Elzawawy, www.icedoc.org

Dr. Brian Issell Interview

ASCO Research Resources — Wed, 01 Feb 2012 19:57:03 GMT


	Brian Issell, MD

Brian Issell, MD, is the Associate Center Director for Clinical Science and Translational Research at the University of Hawaii Cancer Center. He is responsible for the clinical programs of the cancer center, and has been affiliated with the center for over twenty years.

Your hospital is a National Cancer Institute-designated Minority-Based Community Clinical Oncology Program (MB-CCOP). What is a MB-CCOP and how did your organization decide to expand its research program to become a MB-CCOP?

Dr. Issell: A MB-CCOP is a grant provided by the NCI for community institutions that accrue at least 30% of patients with cancer from racial/ethnic minorities. Because our population in Hawaii is 75% minorities (non-white), the MB-CCOP is an ideal fit.

Before we became a MB-CCOP in Hawaii, we were participating in Cooperative Group trials, but in a very fragmented way. My job was recognizing the importance of a clinical trials program. I looked to NCI to see how we could enhance Hawaii’s participation in cancer studies. The Hawaiian population is particularly underserved; Hawaiians and Pacific Islanders typically have a higher incidence of cancer and worse mortality. In addition to treatment trials, we wanted to build a cancer prevention and control program with social scientists, who were particularly skilled at knowing what motivates people who are socio-economically disadvantaged.

For all these reasons, the MB-CCOP was a natural fit for us. Clinical trials are a way of guaranteeing that patients have the best care and access to new opportunities. Through the MB-CCOP, we had a more consolidated approach to clinical trials, more options of trials to choose from, and additional funding. We were also able to build up all the other components which help us access populations that have increased risk and burden of cancer.

Why should early-career investigators be interested in joining one? What advice do you have for investigators who are interested in expanding their programs?

Dr. Issell: What drove me to participate in research was the feeling that I had a greater impact on reducing the cancer burden on the local population. Clinical trials are good for patients, but they’re also beneficial for those who come after them. Community research is particularly important because practice is where it all happens – it is the real world of cancer. We need to translate knowledge into community practice. With our research at UH, we can apply everything immediately into community practice.

Your website notes UH Cancer Center's unique ability to take advantage of:

Hawaii's multiethnic population
Medicinal properties of Hawaii's flora/fauna and
International collaborations with your Pacific neighbors

What unique opportunities and challenges do your location and patient population present?

Dr. Issell: We have the obvious challenges of our physical distance and isolation, but there are a huge number of unique opportunities in Hawaii. We call Hawaii a living laboratory because there is such great diversity and opportunity.

First, we have a unique population with different risks and outcomes. We get to identify why differences among people exist: how are people genetically different and how do environmental differences affect them? One example is the Japanese. Japanese in Japan have the lowest risk of colon cancer, but when they move to Hawaii, they have the highest risk. What causes this? We know their diet changes once in the United States, so that could be a factor. Understanding how genetic differences and environmental exposures (e.g.: exercise) interact can be profound, and it offers dramatic insight in how to personalize treatment and prevention for individuals. We have a tendency to lump everyone together, but we need to understand how people are different.

Second, Hawaii’s geographic isolation has spawned a plethora of unique flora and fauna. Many powerful drugs we already use come from plants, and we take advantage of the opportunity to study more. As an example, we have been examining the anti-cancer properties of the noni fruit. We began by studying its use in Hawaiian folklore and traditional healing, and now we are breaking down the chemical ingredients of the plant to better understand it. Some plants have had really profound influences on cancer treatments, and we have a great opportunity to examine more.

Lastly, we collaborate with neighboring Pacific islands, such as American Samoa, Guam and others in Micronesia. We have an NCI grant to develop cancer programs in Guam, and we work closely with investigators from Australia and the US mainland. We have access to have a large, rich cancer community.

How do you talk with your patients about clinical trials?

Dr. Issell: Our unique population in Hawaii is very willing to participate in cancer clinical trials. Our standard approach is to explain to our patients that everything we know has come from clinical trials and that they will receive, at least, the best standard care. We explain that there’s the opportunity that the care will be even better but also a chance that the experimental treatment may be worse. The most important thing we tell patients is that the information we learn from them is invaluable. This is critical because people want to help and make a contribution to others.

Additionally, because we have so many different cultures and languages, we have systems set up so that we have support through community groups and different agencies to make sure that all the different groups feel welcome. You have to involve the whole community to be successful. People also need to feel ownership of the enterprise. We have needed to pool a lot of resources to establish our program, but we are proud of what we have accomplished. We have so many native Hawaiians and Pacific Islanders in clinical trials that we now have an over-representation of these groups in trials.

What advice would you give to early career investigators?

Dr. Issell: My message, for any clinician, would be that you need to decide to what level you want to be involved in research. Participation can vary from accrual and enrollment to being a Group member. No matter what you choose, you need to make sure you are in a practice that can accommodate your research activities. Research is a collaborative effort. Researchers need to make sure that the people around them support their endeavors because it is too difficult to succeed alone. We collaborate with the people that came before us and with those that come after us to advance the field and improve the quality of care for our patients. If you are committed to making a difference and helping people, this is the way you do it.

Dr. Alan Lyss Interview

ASCO Research Resources — Thu, 01 Dec 2011 17:34:45 GMT

Alan Lyss, MD, is the Director of the Cancer Research Program of Missouri Baptist Medical Center in St. Louis. He is Associate Professor of Clinical Medicine at Washington University School of Medicine and is Associate Clinical Professor at the University of Missouri School of Medicine. Dr. Lyss is the Principal Investigator for Heartland Cancer Research, a designated Community Clinical Oncology Program of the National Cancer Institute. His research interests are directed toward finding improvements in the supportive care of patients who suffer from cancer-related symptoms and increased access to innovative cancer care for under-served populations.

What was your fellowship experience and how did that translate into you becoming a community-based investigator?
My fellowship experience did not lead me to a career in clinical research, but it helped me identify what I enjoyed about the academic setting. My hematology/oncology fellowship at the University of Pennsylvania followed a traditional organization with the first year dedicated to clinical training and the remaining two spent in a laboratory working with an investigator on endothelial cell research. I enjoyed my training but decided that I did not want take my career in that exact direction. Having experienced the flavor of dynamicity of academic research in my training, I knew I wanted to retain it in my future career.

In looking for jobs after my fellowship, I looked for opportunities to see patients, teach, and participate in clinical research (even though I hadn’t directly trained in this area). The position I ultimately took was at Washington University and involved developing a new clinical trials program. It was a blank slate for me, which was at first intimidating but also very exciting.

Do you have advice for investigators interested in starting up a clinical research program?
If a young physician wants to participate in clinical research, he or she should not be dissuaded from taking a position at a practice without a research program. It is worthwhile to lay the groundwork for a new clinical research program because it helps you forge an interesting career and helps you share in realizing a shared vision with potential co-investigators in your community.

In my own experience, I began by engaging with surgeons, radiation oncologists, medical oncologists, and administrators at my hospital to secure the interest and support I needed. With the approval of my division chief, I hired a full-time clinical research associate to head up the research office. I reached an agreement with interested physicians to establish a minimum accrual standard for participation. Our program grew from there.

Your hospital is a National Cancer Institute (NCI)-designated Community Clinical Oncology Program (CCOP). When and how did your organization decide to expand its research program to become a CCOP?
At Missouri Baptist, we considered applying for CCOP status years before actually applying. The CCOP grant application was overwhelming. Finally, propelled by a desire to move our program to another level of service to the community, we decided to partner with another community research program to apply for the grant. Since both our organizations treat patients in rural settings we felt that a CCOP grant would help us expand clinical research opportunities in those communities, in addition to our primary service area in suburban St. Louis. Our application was successful.

What are the benefits of working at a CCOP that early-career investigators should know about?
Working at a CCOP has also enabled us to expand the scope of our research activities. For instance, we now participate in prevention and cancer control trials. We were not doing that to the same extent prior to attaining CCOP status.

Do you have advice for investigators who are interested in expanding their programs?
You also need to win over support and commitment from other members of your own organization and make sure you can get the protected time you need for administrative work. I spend at least 25% of my time attending to CCOP administrative duties as a Principle Investigator (PI). Before applying, it is also important to verify that your organization is invested in publically-funded research. The grant may not advance your organization’s financial standing or replace industry-generated income.

Secondly, it is important for investigators to realize that they can, and should, pair up with other programs in their catchment areas to apply for CCOP status. If you can do so successfully, you have the opportunity to really enhance cancer care and access to clinical trials for your community. It augments that chances that patients in your community will hear the message about the value of clinical trials more consistently and have better access to trials near where they live and work.

As a last word of advice for investigators seeking CCOP funding: it takes a lot of energy and time as a PI to set up your CCOP, but it also takes energy to maintain your heightened standards and accrual numbers. I may have underestimated this commitment at the beginning – but it is tremendously rewarding to know that I have helped create a positive legacy in my community.

How is research incorporated into your practice?
I’m fortunate to incorporate research into every aspect of my practice. I wear a button on my lapel that reads “Research Cures Cancer” because I want my patients to think about research as soon as I enter the room. We have posters about clinical research in every elevator and framed testimonials in every exam room. I let every patient know if they are eligible for a clinical trial. If they aren’t now, they may be at a later time.

I also get to attend scientific meetings and surround myself with smart, creative people. They offer me intellectual stimulation and resource networks. If one of my patients moves to Scottsdale, Arizona, I can seamlessly refer them to physicians I know personally. Similarly, if I have questions about a patient with a rare form of cancer, I can call up a specialist I know through ASCO committee work. Staying connected with the larger oncology community is another way research is incorporated into my professional life.

How do you talk with your patients about clinical trials?
When patients visit an academic center, they expect to hear about clinical trials. When patients come to community practices, they’re not expecting to hear about research, randomization, etc. This makes my conversations challenging. For patients in rural Missouri, the notion of clinical research is especially foreign. The conversation varies with each patient, but I begin every conversation by pointing to my button and acknowledging research as a treatment option. I let them know that I’ve been fortunate to witness a complete transformation of cancer care during the course of my career. The standard treatments available today are the results of clinical research. I tell them about their standard care options, expected outcomes and where I think the next frontier for treatment lies.

What professional development activities would you suggest for early-career investigators?
One cannot read oncology research literature without getting excited about the field. I always counsel students to keep up with their reading. I also encourage them to attend “Meet the Professor” sessions on developing clinical research programs at ASCO Annual Meetings and to attend NCI Cooperative Group meetings. Trainees and fellowship program graduates will get a good sense for how clinical trials are hatched at Cooperative Group meetings. They should be sure to step up to the microphone, ask questions and feel the power and excitement in being involved in the process.

Dr. David Waterhouse Interview

ASCO Research Resources — Tue, 01 Nov 2011 14:49:52 GMT


David Waterhouse, MD, MPH

What position(s) do you hold and where?
I am the Director of Clinical Research at Oncology-Hematology Care, Cincinnati Ohio.

When/how did you decide to make research part of your career?
I’ve always been interested in clinical research. Clinical Research would be my hobby if it wasn’t my job.

What was your fellowship experience and how did that translate into you becoming a community-based investigator?
I completed Medical School and Residency at the University of Massachusetts, and then a HEM/ONC Fellowship at the University of Michigan. After my fellowship I stayed at Michigan where I planned to continue in academics. At that time, however, I wasn’t seen as a “true scientist” because I was doing clinical research. Typically faculty would see patients two days per week and work in the lab three days a week. But the lab wasn’t for me. The clinic was my lab. I kept making excuses to see patients on the protected days. To increase my credibility, I decided to pursue a Master of Public Health degree. The degree was in Epidemiology with an emphasis on Biostatistics and Clinical Trial Design. This degree has helped me in more ways than I ever expected. I was fortunate to have wonderful mentors at the University of Michigan.

Why do you conduct research in a community setting?
I have found that the community setting is a perfect partner to academics. The community is where the patients are being seen. Also, I am able to conduct such research without having to worry about tenure, writing grants, etc. Research allows me many opportunities to partner with superb academic investigators.

Does research add value at your site?
When I left academics and came to Cincinnati there was no cancer research infrastructure at our site, or really within the whole community. We had to build our research infrastructure from scratch. It has been very difficult at times, but more than worth it!

Research adds a great deal of value to our practice. First, it allows our patients access to the latest advances in cancer therapy. Some patients are drawn to our site specifically for this reason. Research also improves physician performance and enhances their fund of knowledge. Doctors are kept fresh and up to date. Again, this is good for our business. Clinical Research also helps to provide a competitive edge to both the individual physician and the practice as a whole. Our research initiatives clearly differentiate Oncology Hematology Care from the rest of the oncology providers in our community. Finally, and importantly, clinical research provides built in quality oversight and is seen as a quality measure by an increasing number of organizations and payors. It provides a strong rebuttal to any question about quality of care.

What advice would you give to early career investigators?

Find a good mentor—Finding a good mentor should be first and foremost. A good mentor should get you started in the right direction. I had a superb mentor, Dr. Ronald Natale. Ron has perhaps the best bedside manner of any doctor that I’ve ever known. He kindly got me started on clinical research and provided much encouragement. He remains so enthusiastic about his work. We are still in contact. I should also mention the help that I have received from Dr. Dean Brenner (Univ. of Mich) who convinced me that I needed to treat clinical research the same way that our colleagues treated the basic sciences—attention to detail, strong scientific rationale, passion. Later, Drs. Hainesworth and Burris from the Sarah Cannon Research Institute have been helping me to bring our research group to a higher level. There remains so much to do and so much to learn. I am still being mentored.
Stay focused on the patient—Conduct research because it is what is best for your patient. I can’t emphasis this point enough. You will face more barriers than you could ever imagine, but if you remain patient-focused and you truly believe that research is in your patient’s best interest, you won’t ever give up. If you’re only doing it for your own benefit, you’ll have less drive when things get tough.
Decide what YOU want to do—Some docs feel like they have to go to the lab but it wasn’t for me. Decide what’s best for you.
Determine what skill-set you need—It’s important to have a long-term view of the world and consider what skills you’ll need in the future. Being a successful investigator requires different skills then being a successful physician. The same is true of being an administrator. Determine what you need for the path you plan to take. Work to develop those skills as early as possible.

Please elaborate on your last point. Specifically, what skills did you need to develop?
I had to learn leadership skills. Leadership comes naturally to some people but not necessarily to me. Fortunately these are teachable skills. My MPH classes set a good foundation and I still read a lot of leadership articles and books. I probably read as much about leadership as I do oncology topics. If you’re going to be a leader, then you need to know how to lead. If you’re going to manage a research program, than you also need to know how to manage. People skills are imperative. I have found that being a good physician has been easy but being a good manager has been very difficult.

What was the best piece of advice ever given to you?
In regard to medicine, the best advice came from another mentor and friend, Dr. Richard Levy who founded Oncology Hematology Care. He told me that business and medical decisions don’t have to be hard. Decisions should always be based on what is best for the patient. Then, after the patient’s needs have been satisfied, take into consideration what is best for your organization, and only last what is best for yourself. If a decision is patient centric, it can always be justified and defended fearlessly. Today I sometimes see people getting away from these principles.

Is there anything you’d like to add?
There are many benefits to clinical research that a young doctor won’t understand until they’re more seasoned like me. So I’ll tell them what they are:

You become a better doctor when you conduct clinical research. Patients and colleagues perceive it well and it enhances your clinical expertise. It keeps you fresh. You’ll remain a good doctor as you age.
Clinical research puts you in frequent contact with the movers and shakers in the field. You understand the scientific concepts and stay current. New drugs don’t intimidate you.
Lastly, clinical research should not just be the “jimmies on the ice cream cone”. Research is not something you consider for your patient intermittently or when the clinic is running on time. You should consider it a standard and integral part of the way you treat patients. Think about the quote NCCN includes on every guideline: "NCCN believes that the best management of any cancer patient is in a clinical trial." I believe in the importance of this quote so much that I include it in my electronic signature.

Dr. Gary I. Cohen Interview

ASCO Research Resources — Fri, 30 Sep 2011 16:20:22 GMT

Gary I. Cohen, MD, FACP, is the Medical Director of the Sandra & Malcolm Berman Cancer Institute at the Greater Baltimore Medical Center (GBMC). He is also the GBMC Director of the Johns Hopkins Clinical Research Network and holds an appointment as an Assistant Professor in the Department of Oncology at the Johns Hopkins University. Dr. Cohen is active with the Eastern Cooperative Oncology Group (ECOG) where he chairs the Community Scientific Committee and is the Community Co-Chair of the ECOG Melanoma Committee. Dr. Cohen is also a leader at the American Society of Clinical Oncology (ASCO) where he has volunteered on numerous committees and is currently a member of the ASCO Board of Directors.

When did research become a part of your career?
Research has always been a part of my career- it helped me become a better physician and provides a more rewarding professional life.

How did you decide to make research part of your career?
My career started at the Dana Farber Cancer Institute where I thought I would stay and do basic and clinical research. But I realized that I enjoyed seeing patients more. I decided to relocate from the Farber to a community setting where I could focus specifically on patient care and incorporate clinical research. Conducting clinical research in a community setting is the perfect opportunity to merge the benefits of the academic and private practice settings.

What was your fellowship experience and how did that translate into you becoming a community-based investigator?
I’d say that most fellowships do not prepare physicians well for careers in community-based research. A lot of physicians have to re-educate themselves when they enter the community setting. Fortunately there are a lot of resources to help physicians acquire competence. The extra effort is well worth the time.

What specific resources do you recommend?
There are a number of resources available through NCI and ASCO. Some of the ASCO resources I’d recommend are:

I’d also suggest ASCO’s Conquer Cancer Foundation because it offers several grants and awards for funding clinical research and training oncologists, and ASCO’s patient education website Cancer.Net, which offers patient-friendly information about understanding and participating in clinical trials.

How is research incorporated into your practice?
Clinical trials are part of our culture and enable us to provide the best care to our patients. I try to have the opportunity for clinical trial participation available for most of the patients seen at my site—which means we need to have a lot of trials available. Clinical trials are inherently designed for specific subsets of patients so we open several trials for each diagnosis. To meet this need we offer trials sponsored by NCI, the pharmaceutical industry and investigator-initiated trials either from our own investigators or through a partnership with regional academic programs. Altogether, we usually maintain 55-60 active clinical trials for oncology patients.

However, if you are just starting out, I’d recommend focusing on one or two areas until you become proficient. It’s better to do a few trials well then to conduct a lot of trials poorly.

You established the Cancer Center at GMBC. Do you have any advice for someone establishing a new community-based research program?
I’d recommend becoming affiliated with an NCI mechanism. Options include affiliating with a NCI-designated site like a Community Clinical Oncology Program (CCOP), joining a NCI-funded Cooperative Group, or conducting trials through the Clinical Trials Support Unit (CTSU). Clinical trials sponsored by the pharmaceutical industry are typically more difficult to break into. Most pharmaceutical companies look for sites that have already demonstrated competence. If you are still establishing the reputation of your site, one strategy to break into this arena is to start by offering Phase 4 pharmaceutical-sponsored trials. Pharmaceutical companies are usually less selective about the sites they partner with to conduct these trials so it’s a great way to establish relationships with new sponsors and prove the competence of your site.

Did you have to overcome any obstacles to get where you are today?
Clinical trials won’t make you rich but the benefits are great. Early in your career you may spend a lot of volunteer time establishing yourself with organizations you are affiliated with. I dedicated a lot of time establishing myself with ECOG, ASCO, and a local partnership with Johns Hopkins University. I was not reimbursed for my time but it was worth every minute. The work was satisfying and I was able to increasingly assume leadership positions. The expertise and professional rapport I developed enabled me to pursue additional opportunities such as giving lectures at venues such as the ASCO Annual Meeting, which is something I really enjoy doing.

What advice would you give early-career investigators?

Community-based research is doable and worthwhile- don’t be discouraged by people who think you need to be in academia to conduct research.
Embrace the concept that being involved in research helps you become a better physician, and a better person.
Appreciate that you will gain the respect of colleagues more quickly if you participate in clinical trials.

The field is constantly changing. How do you keep up?
There are many journals that both report on clinical trial outcomes and review articles about conducting clinical trials. The Journal of Oncology Practice (JOP) is a very useful resource regarding practice-related issues and conducting research.

Do you have any concluding advice?
Conducting clinical research will make you a better physician and the opportunities to conduct research in a community setting are active, rewarding, and plentiful. I’ve found that community-based research is a perfect mix of the benefits from academia and private practice settings.

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Dr. Nicholas Petrelli Interview

ASCO Research Resources — Tue, 30 Aug 2011 20:42:54 GMT

Dr. Nicholas Petrelli is the Bank of America Endowed Medical Director at the Helen F. Graham Cancer Center at Christiana Care Health Services in Newark, Delaware, Professor of Surgery at Thomas Jefferson University, and Adjunct Professor at the University of Delaware in the Department of Biological Sciences.

When did you decide to make research part of your career?
It was in my fourth year of general surgery residency in San Francisco. I was in a program where research was a part of the general surgery training. After the residency I went to the Roswell Park Cancer Institute for my surgical oncology fellowship where I collaborated with both clinical and laboratory research investigators. The environment I was in was conducive to both taking care of patients and research so it was a natural setting for clinical and translational research. The fellowship taught me about the natural history of cancers, the multidisciplinary care of the cancer patient, and all aspects of academic life. They used to call it the triple threat: patient care, teaching and research.

You started your career in an academic setting, and then moved to the community setting, what prompted the switch?
I spent 22 years at Roswell Park in academia and then in 2001 came to the Helen F. Graham Cancer Center which is community based. So I’ve been on both sides of the fence so to speak. By the time I left, Roswell Park had a very good Department of Surgical Oncology and Surgical Oncology Fellowship program so I was looking for a new challenge.

I had no intention to go to a community setting. I had looked at several cancer centers, university based. Then on the recommendation of a colleague of mine, I went to Delaware to look at Christiana. The challenges and opportunities enticed me to come here; Delaware was number one in cancer incidence and mortality, Christiana had the resources to build a strong cancer program, Christiana already had a good infrastructure for clinical trials, there was a great opportunity to build translational research, and the State was extremely supportive in making a dent in cancer incidence and mortality. It turned out to be the challenge I was looking for.

How was the transition from the academic to the community environment?
It wasn’t an easy adjustment after 22 years in academic medicine to go to a community based institution. I had to explain my vision to the physicians on campus but at the same time I had to learn what they were doing in private practice. A lot of times at the university we’d say “those guys in private practice don’t know what they’re doing” but that’s not the case. I quickly realized that there are extremely qualified individuals in private practice who could help me build a program. If you look at accrual of clinical trials, especially NCI trials, across the country, the high accrual comes from the community programs. It took me a little while to learn that, but I did and that’s one of the reasons we have one of the best community based cancer centers in the United States.

Was the site set up for research before you got there?
Only the NCI clinical trials were set up thru the funded Community Clinical Oncology Program ( CCOP) . The accrual rate was around 7% or 8%, and after building the program it’s now 24% accrual which is 7x the national average. NCI uses it as a model. There really wasn’t an organized translational cancer research model available on campus. I formulated the Center for Translational Cancer Research which is 6,000 square feet of laboratory space here at the Graham Cancer Center and a collaborative effort with the University of Delaware. The pharmaceutical trials program was somewhat fragmented because each of the trials was going on within each of the mecical /hematologic oncology private practices. After a few years of developing a track record we moved those trials under the auspices of the Graham Cancer Center, and that also has increased our accrual to pharmaceutical trials. So there was an infrastructure here, but it is significantly better than it was 9 years ago.

What is the role of research within the institution?
It’s a core function. Our top priority is to get patients on NCI clinical trials. We know they get better care on trials and the NCI trials give us more credibility in the community. Having over 120 NCI clinical trials gives us credibility with the public, and of course in 2007 we were selected as one of the first 14 NCI Community Cancer Center Programs (NCCCP) in the Country. The public understands they don’t have to leave Delaware for their cancer care; a lot of them were 9-10 years ago. It’s also attracted top quality physicians when we recruit. When they know we have NCI trials and our accrual rate is over 20%, it allows us to attract quality physicians and quality nurses. And if you add on to that the Center for Translational Cancer Research, where we’ve been able to recruit MD/PhDs, it becomes a very productive environment with high quality care and good research both on the clinical and scientific side.

What were some of the challenges in building this and integrating the pieces?
There’s certainly a list of them. Number one, the building wasn’t here when I first got here, so we didn’t have all the cancer resources under one roof. One of the major challenges was convincing the physicians that would be the way to go. Another challenge was building Multidisciplinary Disease Site Centers (MDCs). We now have 14 disease site centers where when a patient comes in with a specific cancer they’re seen in these centers by a surgeon, a medical oncologist, a radiation oncologist, pulmonologist, gastroenterologist, interventional radiologist, depending on the center, along with all the support staff like nurse navigators, psychology, genetic counselors ,nutritionalists and pastoral care . Putting that together and demonstrating to the private practice physicians that this would work was a major challenge. We started off with thoracic and head and neck as our first two MDCs and built a track record with them. Patient satisfaction went sky high because now patients were getting their treatment plans in one day rather than waiting 4 weeks.

How do you keep up with constantly changing science?
Read both online and with paper journals. I’m up around 5:15am and read for about 45 minutes, then get ready to go to work. I’ve been doing that for close to 25 years. You just have to make the effort – no matter how busy you are you can find time during the week to skim through journals either online or on paper to stay current with your area of interest. Nights and weekends are great times to catch up on one’s reading Also, the local and National meetings are important. There’s not only the ASCO Annual Meeting which is getting very big, there’s the Best of ASCO, the Society of Surgical Oncology, and the AACR meetings. You don’t have to travel since a lot of them are done regionally. Within one’s own institution there are grand rounds with visiting professors so there’s an enormous amount of opportunity to stay current.

What was some of the best advice you received?
There are three pieces of advice that I’ve been given in my career that I think are important to young investigators. One is to treat a patient the way you’d want to be treated. Two, never tell a patient when they’re going to die because they may out live you. Three, research will make you a better physician.

Research encompasses several things. Part of research requires staying on the cutting edge which requires that you read the latest updated information that comes out both on the clinical side and the scientific side. That reading increases your knowledge base, makes you a better physician to understand the diagnosis and treatment of cancer, and teaches you how to deal with failure. Not all research is successful, and failure teaches you that you just have to find out why you failed and go in a direction where you’re not going to fail again. I tell my trainees in surgery that you want to spend as much time becoming the best physician you can be because even as a surgeon you’re going to make mistakes. The good surgeon does two things – number one, recognizes the mistake and number two knows how to take care of it. That not only makes you a better physician but that makes you a better person because obviously we don’t go through life without making mistakes.

What would be your advice for new investigators?
Four things: First, young investigators have to find a good mentor, one who is going to be committed to them both in their professional and personal life. If you find a good mentor, that mentor will be your mentor for the rest of your life, not only your career. Second, get involved in the NCI cooperative groups because that’s one of the best places to learn about the intricacies of clinical trials. Third, sit on an institutional review board, even if it’s only for a few meetings. It’s a great opportunity to review protocols and learn what’s safe so that we don’t hurt our patients. Lastly, never say no when asked to review a manuscript as an ad hoc reviewer. Learning how to review and interpret manuscripts is an important part of being a good physician.

How can young investigators participate in clinical trials in the community setting?
It’s not easy because it requires resources, and the resources from the NCI at the moment are not enough. Physicians can participate in the Cancer Trials Support Unit (CTSU), the clinical trials unit of the NCI, but they’re going to need the resources in their practice to do that. Another way is to join with a CCOP in their institution or a main member institution of the cooperative groups. Like anything else it takes some effort and it takes resources. None of this we talked about today is easy but if it was easy anybody could do it!

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