|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?
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?
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?
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?
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?
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?
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?
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?
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.