Innovations to improve the efficiency of phase II IBD clinical trials

Nat Rev Gastroenterol Hepatol. 2023 Sep;20(9):555-556. doi: 10.1038/s41575-023-00805-z.

Abstract

Inflammatory bowel disease (IBD) clinical trials face a recruitment crisis. This is attributable to multiple individual trials competing for the same pool of participants, growing sample size demands and the increased availability of licensed alternative options for many potential participants. We need phase II trials that are more efficient both in design and in outcomes measured in order to deliver earlier and more precise answers, rather than simply offering a crude preview of what a subsequent phase III trial might look like.

MeSH terms

  • Clinical Trials, Phase II as Topic* / standards
  • Humans
  • Inflammatory Bowel Diseases* / drug therapy