Inflammatory Bowel Disease Patients' Perspectives of Clinical Trials: A Global Quantitative and Qualitative Analysis

David T Rubin; Laurent Peyrin-Biroulet; Walter Reinisch; Swati Tole; Laura Sullivan; K T Park; Miguel Regueiro

doi:10.1093/crocol/otab079

Inflammatory Bowel Disease Patients' Perspectives of Clinical Trials: A Global Quantitative and Qualitative Analysis

Crohns Colitis 360. 2021 Dec 9;3(4):otab079. doi: 10.1093/crocol/otab079. eCollection 2021 Oct.

Authors

David T Rubin¹, Laurent Peyrin-Biroulet^{2

3}, Walter Reinisch⁴, Swati Tole⁵, Laura Sullivan⁵, K T Park⁵, Miguel Regueiro⁶

Affiliations

¹ Department of Medicine and Biological Sciences, University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, Illinois, USA.
² Department of Gastroenterology, Nancy University Hospital, Vandoeuvre-Les-Nancy, France.
³ Department of Gastroenterology, Inserm U1256, Lorraine University, Vandoeuvre-Les-Nancy, France.
⁴ Department of Medicine, Medical University of Vienna, Vienna, Austria.
⁵ Clinical Science, Genentech, Inc., South San Francisco, California, USA.
⁶ Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic Foundation, Cleveland, Ohio, USA.

Abstract

Background: Despite recent progress, inflammatory bowel disease (IBD) therapies with pronounced long-term efficacy and improved safety are needed. IBD clinical trials face challenges with patient recruitment because of study designs, competitive or overlapping trials, and limited numbers of eligible patients. We aimed to better understand patients' awareness of, attitudes toward, and experience with IBD clinical trials.

Methods: This multinational, cross-sectional cohort study of adults with IBD recruited online consisted of 2 components: a quantitative 15-minute online survey completed by all participants and a qualitative 30-minute telephone interview completed by a subset of patients from the United States.

Results: Quantitative survey respondents (N = 226) included patients with ulcerative colitis (52%) and Crohn's disease (48%) from the United States (n = 100, 21 of whom were interviewed), Brazil (n = 26), Canada (n = 25), France (n = 25), Germany (n = 25), and Spain (n = 25); 96% of respondents reported at least a basic understanding of clinical trials. Patients rated conversations with health care providers most helpful for researching trials, but during interviews patients discussed their desire for increased patient-physician communication about trials. Major barriers to participation included invasive screening/monitoring (35% of quantitative responses) and concern over receiving placebo (35%) or suboptimal treatment (33%). Most respondents (68%) reported that clinical trial participants are "guinea pigs" for an experimental treatment.

Conclusions: Opportunities to improve participation in IBD trials include improved communication with health care providers, further patient education, and alternative trial designs. Ultimately, a better understanding of the patient perspective will be important for more informed patients and more successful recruitment and enrollment.

Keywords: Crohn’s disease; patient preference; patient survey; ulcerative colitis.