Crohn’s disease and ulcerative colitis patient perspectives on clinical trials and participation

Abstract BackgroundClinical trial recruitment is often the rate-limiting step in the development of new treatments reaching patients across all disease states. With more than 1500 currently available clinical trials for inflammatory bowel diseases (IBD) patients, it is important to understand patient perceptions of clinical trial participation to improve recruitment and retention. This study aimed to examine the specific challenges and barriers that might be reducing IBD patient enrollment and potential methods to overcome these barriers. MethodsFive in-person patient focus groups were conducted from February through May 2016 using two facilitation guides. Participants self-reported a diagnosis of Crohn’s disease or ulcerative colitis. ResultsThe five focus groups included a total of 34 participants. Participants discussed several barriers, including fears, disease severity at trial onset, potential adverse effects, time constraints, and the influence of both their primary IBD provider and support network. Methods to improve participation included better communication to prospective patients, reduced length of trial and time commitment, lower placebo rates, the option of open label extension, and support of the patient’s primary IBD provider. ConclusionsThis is the first study to examine patient perceptions for IBD clinical trial enrollment, including barriers to participation and methods to improve participation. Fear and misunderstanding of clinical trials, engagement with providers, limiting time demands, and limiting the impact on work and family were found to be barriers to participation. Creative solutions to these problems could lead to greater participation in trials and more rapid advancement of new therapies to clinical approval and use.