|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.