I just spent a fantastic week teaching at the RSNA Clinical Trials Methodology Workshop. This 5-day bootcamp provides intensive training in how to design and execute clinical trials. And I mean intensive! Most days start at 7AM, and both students and faculty work well into the evening. After mornings of lectures on statistical methods and trial design, the international faculty break up into small groups with 4-5 students each who spend the week writing their own protocols. The students were young assistant professors from as far as Brazil and Korea. Faculty expertise was diverse, including diagnostic radiologists in multiple sub specialties, outcomes and cost-effectiveness researchers, statisticians, ethicists, and radiation and interventional oncologists.
Each student had a clinical trial proposal as part of their application to the course. A standard template was provided, with sections due each evening for faculty critique. Having 5 protocols to review every night certainly put a damper on evening libations! The final product was a complete protocol and consent ready to be reviewed with collaborators at the home institutions, submitted to the IRB, and shopped around for funding.
Since it is an RSNA program, most of the didactic program and protocols focused on imaging, with limited content on traditional therapeutic clinical trial design. (ASCO offers a similar bootcamp for cancer trial design.) We had two radiation oncology trials and two IO trials in my protocol group. It was exciting to watch these protocols develop over the course of the week from initial concepts into well-honed, statistically solid trials.
RSNA has run this program for eight years, and estimates that about half of the students actually launch their trials. The course is more than a training program, it is an incubator for clinical research. When else can a junior faculty member get a week to devote to writing a trial, with expert stats and senior faculty as mentors? RSNA would like to see more applicants to the program. This is a great opportunity for young IO faculty to write a clinical trial on something that excites them, and learn to do it right.