Among the 2012 accomplishments in the world of cancer was the approval by the U.S. Food and Drug Administration of eleven new agents for the treatment of cancer–drugs ranging from pertuzumab for breast cancer to ponatinib for chronic myelogenous leukemia. The hard work of bringing a new agent from the lab to human application rests in part on the meticulous performance of rigorous clinical trials. These trials span the spectrum from phase I trials that assess toxicity, dose and schedule of a new agent to phase II trials that establish efficacy of a new agent in a specific disease setting to phase III trials that compare a new therapy with an established therapy.
We at the University of Pittsburgh Cancer Institute (UPCI) and UPMC CancerCenter take great pride in our commitment to the clinical trial process because we believe participation in a clinical trial is the optimal form of therapy for patients who are willing and able. Indeed participation in a clinical trial where possible and appropriate is always the first recommendation for patients in our evidence–based clinical pathways program. Our commitment is exemplified by our numbers. In any year, about 1,000 of our patients choose to participate in interventional trials–those trials that test a treatment or intervention–while several thousand patients agree to participate in non-interventional trials, studies that might involve special study of their tumor specimens, for example. Participation in a clinical trial is of course always voluntary. Both the patient and the doctor must agree that it represents the best way forward for that patient while allowing us to learn something for the future along the way.
Clinical trials are about great ideas and good science but they are also about people–patients and providers who give of themselves to develop new knowledge to advance our field. The science of clinical investigation is just as exacting as traditional laboratory bench-based research and it requires the same commitment and energy. That is why I was so pleased to be able to participate in a ceremony at the National Cancer Institute last month where two of our clinical investigators were recognized as recipients of National Cancer Institute Cancer Clinical Investigator Team Leadership Awards, an honor that recognizes exceptional clinical investigators for their contribution to the advancement of clinical research through collaborative team science and brings $50,000 in research support over two years. Shannon Puhalla, M.D., assistant professor of medicine, received a 2012 award to support her work in new drug development for breast cancer, while Julie Bauman, M.D., assistant professor of medicine, was recognized for her 2011 award that she received while at the University of New Mexico to underwrite her research in head and neck cancer. Though the award cannot transfer with Dr. Bauman now that she has moved to UPCI, we are delighted that she will bring her expertise to bear in her new environment. As a long time clinical trialist myself, it was a special pleasure to be able to attend this event showcasing the clinical trial leaders of the future.
Not everyone is destined to design a clinical trial but many oncologists contribute selflessly to the clinical trial process by informing patients about options and encouraging and supporting patients during and after their participation. They work at many locations and across all disciplines. Indeed a preview of our own statistics for enrollment of patients to therapeutic clinical trials in 2012 shows our biggest contributors included medical oncologists James Ohr (51 patients), Hussein Tawbi (45), Shannon Puhalla (39), and John Kirkwood (35); radiation oncologist Dwight Heron (35); and surgeon Jonas Johnson (23). Kudos must also go to community medical oncologist Matthew Sulecki (16) as well as the team at Arnold Palmer Cancer Center's Mountain View Medical Park facility who enrolled 35 patients.
And of course the unsung heroes are those patients who put themselves on the line.They realize everything we know about how to care for patients with cancer today is derived from the knowledge gained from yesterday's patients and clinical trials. We cannot thank them enough.
That the clinical trial process is bearing fruit is demonstrated in part by the steady decrease in cancer incidence and mortality in the U.S. We hope that 2013 will be even more successful as we try to identify tomorrow's therapy through the conduct of today's clinical investigations. This truly is one of our most important missions in our quest to move new knowledge from the lab to the clinic to the community.