Interpreting Registrational Clinical Trials of Biological Therapies in Adults with Inflammatory Bowel Diseases

Ghosh, S., Sandborn, W. J., Colombel, J. F., Feagan, B. G., Panaccione, R., Hanauer, S., Schreiber, Stefan, Peyrin-Biroulet, L., Vermeire, S., Eichner, S., Huang, B. D., Robinson, A. M. and Pappalardo, B. (2016) Interpreting Registrational Clinical Trials of Biological Therapies in Adults with Inflammatory Bowel Diseases Inflammatory Bowel Diseases, 22 (11). pp. 2711-2723. DOI 10.1097/MIB.0000000000000909.

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Supplementary data:


Background:The use of biologics to treat inflammatory bowel disease is supported by robust randomized controlled trials in both ulcerative colitis and Crohn's disease. Nonetheless, an understanding of the principles of clinical trial design is necessary to extrapolate study findings to clinical practice.Methods:We conducted a review of inflammatory bowel disease registrational clinical trials of biologics to determine how differences in trial design potentially influence results and interpretation.Results:Registrational trials of biological agents have used diverse patient populations, outcome measures, and designs, which makes comparisons of results among studies difficult. Key differences among trials include patient populations, choice of symptom-based measures or objective outcomes as endpoints, and overall trial design. Additional factors, including analytical methods, can also influence the interpretation of outcomes.Conclusions:The most robust evidence is derived from comparative effectiveness trials. In the absence of these, clinicians should be aware of the various methodological issues which could impact interpretation of efficacy and safety outcomes, including differences in patient population, study design, and analytic methodology.

Document Type: Article
Additional Information: Times Cited: 0 Ghosh, Subrata Sandborn, William J. Colombel, Jean-Frederic Feagan, Brian G. Panaccione, Remo Hanauer, Stephen Schreiber, Stefan Peyrin-Biroulet, Laurent Vermeire, Severine Eichner, Samantha Huang, Bidan Robinson, Anne M. Pappalardo, Brandee
Research affiliation: OceanRep > The Future Ocean - Cluster of Excellence
Kiel University
Refereed: Yes
DOI etc.: 10.1097/MIB.0000000000000909
ISSN: 1078-0998
Projects: Future Ocean
Date Deposited: 09 Mar 2017 11:12
Last Modified: 19 Dec 2017 12:43

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