Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

With the increase in the number of novel drugs for inflammatory bowel disease (IBD), comparing therapeutic options or strategies has become a key challenge in IBD trials. Head-to-head trials designed and powered to enable formal comparisons are the gold standard in comparative research. Indeed, these trials are requested by some health authorities for evaluating the positioning of new treatments in IBD, as well as helping prescribing physicians to select the most appropriate treatment options for their patients. Despite head-to-head trials including aminosalicylate therapy in IBD having been performed decades ago, the first results of a randomized controlled trial directly comparing biologic agents with different modes of action have only now been published, mainly owing to important methodological issues. This Perspective provides an overview of the past, current and future concepts in IBD trial design, with a detailed focus on the role of comparative research and the challenges and pitfalls in undertaking and interpreting the results from such studies.

Original publication




Journal article


Nat Rev Gastroenterol Hepatol

Publication Date





365 - 376


Biological Products, Biosimilar Pharmaceuticals, Double-Blind Method, Equivalence Trials as Topic, Gastrointestinal Agents, Humans, Immunosuppressive Agents, Inflammatory Bowel Diseases, Meta-Analysis as Topic, Network Meta-Analysis, Observational Studies as Topic, Outcome Assessment, Health Care, Randomized Controlled Trials as Topic, Single-Blind Method