title: Interpreting Registrational Clinical Trials of Biological Therapies in Adults with Inflammatory Bowel Diseases.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: *Department of Medicine, University of Calgary, Calgary, Alberta, Canada; †Division of Gastroenterology, University of California San Diego, La Jolla, California; ‡Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; §Robarts Clinical Trials, Robarts Research Institute, Department of Medicine, University of Western Ontario, London, Ontario, Canada; ‖Department of Medicine, Division of Gastroenterology and Hepatology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; ¶Department of Medicine, University Hospital Schleswig-Holstein, University of Kiel, Kiel, Germany; **INSERM Unité 954, Department of Gastroenterology, University of Lorraine, Nancy, France; ††Department of Gastroenterology, University Hospital Leuven, Leuven, Belgium; and ‡‡AbbVie Inc., North Chicago, Illinois.
authors: Subrata
authors: S
authors: Ghosh
authors: William J
authors: WJ
authors: Sandborn
authors: Jean-Frederic
authors: JF
authors: Colombel
authors: Brian G
authors: BG
authors: Feagan
authors: Remo
authors: R
authors: Panaccione
authors: Stephen
authors: S
authors: Hanauer
authors: Stefan
authors: S
authors: Schreiber
authors: Laurent
authors: L
authors: Peyrin-Biroulet
authors: Severine
authors: S
authors: Vermeire
authors: Samantha
authors: S
authors: Eichner
authors: Bidan
authors: B
authors: Huang
authors: Anne M
authors: AM
authors: Robinson
authors: Brandee
authors: B
authors: Pappalardo
mesh_terms: D000328:Adult; D001691:Biological Therapy / Q000379:methods*; D003093:Colitis, Ulcerative / Q000628:therapy*; D003424:Crohn Disease / Q000628:therapy*; D003627:Data Interpretation, Statistical; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012107:Research Design