Clinical Trial Issues

Investigating the efficacy of potential new therapies in the treatment of IBD through clinical trials is not straightforward. The heterogeneity of the condition, in particular CD, and the large number of potential endpoints that can be employed in studies are just two of the complexities that need to be considered in clinical trial design. Furthermore, clinical trials are predominantly of two types, those studying efficacy to treat active disease and those designed to study the efficacy in maintaining disease remission, and are likely to have different objectives and challenges. There is only limited regulatory guidance in this area.

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