Last year I wrote a blog
about the ASCO/AACR Methods in Clinical Cancer Research Workshop, also known in both organizations as "the Vail course
." The Vail course is a favorite of mine, and I am happy to be back again, participating as a faculty member. The course brings together "students" (fellows and junior faculty) and a faculty made up of genuinely top-notch clinical and translational researchers, biostatisticians, and (exceptionally useful) patient advocates. The meeting this year is ably led by Chair Nora Disis and Co-Chairs Lee Ellis and Mithat Gonen.
The pace is fairly brutal, both for students and faculty. In addition to a full schedule of didactic lectures, the students and faculty meet every day for protocol development sessions in a small group setting. The give and take at these sessions is wonderful: part practical advice, part philosophizing, part critique. The learning curve is steep.
Students come to the meeting with a clinical trial proposal, and by the end of the week have a fully written clinical protocol with informed consent. As I look at the schedule, several nights the students turn in assignments at 9 p.m., followed by the faculty going over the assignments until the wee hours of the morning. I saw a bunch of bleary-eyed faculty this morning.
Yesterday's focus involves clinical trial ethics, the informed consent process, and investigator responsibilities. Jamie Von Roenn
and Mary Scroggins role-played a doctor-patient informed consent discussion. Even though I have been having such discussions for thirty years, the role-playing pointed out holes in my own approach, and the difficulty of such discussions for both doctor and patient.
These difficulties are many. When does a doctor recommend a new therapy over a standard therapy? How does one explain the potential side effects of a novel agent, where the side effects are uncertain? How do you honestly discuss benefit, knowing that most new agents fail? To what extent do you get into the financial implications of a clinical trial? And, a common issue, how do you answer the "what would you do in my situation, doc" question?
Clinical trials represent the point at which modern science intersects with medical ethics. As physicians we tend to make the ready assumption that our ethics are above reproach. After all, we reason, we went into this field to help people, and by bringing new agents to our patients we are doing our best to help them in a tough situation, and to advance the care of future patients. But life is messy. Many situations in medicine are inherently coercive, or at least hold the potential for coercion, few more so than when a desperate patient running out of options comes to you for help. So understanding not just the practicalities of clinical trials, but also the ethical principles underlying those trials, is what separates us from the quite well-trained moral idiot Dr. Mengele of Auschwitz, or (closer to home) the U.S. Public Health Service officers at Tuskegee.
The Vail course is a great place for the next generation of clinical trialists to start their careers. I look at the students in my study group, and I know the future is in great hands. Theirs should be the generation that beats this awful disease, as they leverage the rapid advances in our understanding of tumor biology to create major clinical progress. And looking at them, I am again proud to be part of a society that cares deeply about patients and about the future of clinical research.