Know when to fold ’em
Knowing when to close a study is far easier said than done. The sunk cost fallacy says it is much harder to abandon a project after investing so many resources into it. For us, it was the recruitment timetable that gave us pause. Finishing trial accrual by the end of my advanced fellowship year was wholly unfeasible. When it became clear that nobody in the department could see it through to completion, I was propelled to terminate the study. If there is concern about termination, I suggest sending the protocol, recruitment numbers, and timeline to an outside colleague for a second, unbiased opinion. Review the already compiled data for any notable findings worthy of a smaller publication. It is said, we often learn more from our failures than our successes. The experience described herein – largely in part to my mentors, collaborators, and the patients who put their faith in me – translates to a lasting, invaluable win.
Dr. Gil Y. Melmed
Mentor’s note
Clinical research is hard. Many trainees meet with me to “get involved” in clinical research, and the challenge as a mentor is to identify a project appropriate to the level of training and provide the infrastructure and resources to facilitate success for the motivated trainee. Trainees have various goals of their involvement in research – to foster a relationship in the hopes of receiving a strong letter of support, to facilitate getting into a competitive training program, and/or to publish. My goal as a mentor is to help my trainees reach their goals, but as a clinical researcher, I look for the trainee’s desire to engage with and learn the research process, with the ancillary potential for a letter, for acceptance to a program, or for publication.
This particular study, a randomized, controlled trial of vitamin D in patients with Crohn’s disease, involved an enormous undertaking by a very motivated trainee who took the project from its inception; to putting a thoughtful grant proposal together; to developing a full clinical trial protocol with its ancillary regulatory documents; and obtaining institutional review board approval, statistician input, pharmacy support, and buy-in from faculty and ancillary staff stakeholders. The study ultimately failed because of low enrollment – patients did not want to participate (for reasons elucidated above) – not because of poor design or execution of the myriad components of a prospective clinical trial. Low enrollment has led to the failure of many otherwise excellent studies, including several in our field of IBD.1,2 As a mentor, it is rational to accept blame for the failure of a trainee project; how could I have better foreseen the outcome of this study? Could this have been prevented with more support, more oversight, or more “micromanagement,” to the potential detriment of fostering independence?
Ultimately, the value of clinical research to trainees is multifaceted. If the goal was a first-author publication with high clinical impact, this trial failed. But if the goal was to learn about the clinical trial process, this study was a resounding success. Ultimately, it behooves trainees and their mentors to engage in early, upfront conversations about research. What are the goals? What does success look like? What if the trial fails? By shifting the focus from the success of the project to the success of the mentorship and educational process, even failed projects are resounding successes, upon which future careers can be further developed.
