The lectures are broad and not too in-depth, so they will be applicable to most attendees. Most of the lecture slides are available on a flash drive that you will receive when you arrive, so you will not have to scribble notes the whole time. Bring your own laptop. Although there is a computer lab, having your own hardware is helpful.
The essence of the workshop is in the small-group sessions. You will be asked to defend your idea to about 8 or 9 other workshop attendees, a statistician, 2 faculty members, and a patient advocate. Many times, the trial concept will be radically altered by the group or the faculty. Be willing to be flexible. This is the time where you will be sorely disappointed if you had a randomized phase II design already written and it gets critiqued into a single-arm phase I study.
If you need extra assistance, every faculty member has “office hours” for one-on-one time. Take advantage of the opportunity to meet opinion leaders and key members of the research community. Not only can they improve your protocol, they can help provide you with career advice or some direction on future trial concepts.
When you are not in lectures, small-group sessions, or office hours meetings, you will be writing. You will need to turn in a protocol development sheet (ie, a brief summary of the trial after its initial revision), a statistical design, rough draft, informed consent, and final copy. In total, it will end up being more than 50 pages of text. It seems like a lot, but the templates are incredibly helpful for keeping your protocol in proper order. By the time you complete the workshop, the document you produce will be nearly ready for a review committee back home.
Taking the Lessons Home
While the workshop cannot teach every nuance of clinical research in the span of a week, it will certainly illuminate some of the critical steps required for turning a hypothesis into a study with maximal potential for achieving its objectives. Applying the tools learned in terms of statistical methods, correlative end points, or useful biomarkers will help you in any future research endeavor. Spread the lessons around to your co-fellows and be a helpful reviewer of your colleagues’ ideas. Stay in touch. Your faculty members from Vail will want to hear how your protocol went and how your career is going. Their feedback can be helpful well beyond the week you spend in the mountains.
My time at the Methods in Clinical Cancer Research Workshop was one of the most challenging—but fun—experiences of my fellowship in oncology. I hope these refl ections will encourage you to submit your own application!
Sam J. Lubner, MD, is assistant professor at the University of Wisconsin Carbone Cancer Center in Madison.
This edition of Oncology Fellows is supported by Genentech, a member of the Roche Group.