> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Data Monitoring Committees Need Flexibility: Study
- URL: https://www.fdaweb.com/data-monitoring-committees-need-flexibility-study/
- Published: 2016-10-06T12:00:00.000Z
- Updated: 2026-09-14T21:37:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137023

Researchers from the University of Wisconsin and the University of Pennsylvania [report](http://www.nejm.org/doi/full/10.1056/NEJMra1510066?rss=searchAndBrowse&&ref=fdaweb.com) in the *New England Journal of Medicine* that data monitoring committees (DMCs) need to be prepared for the unexpected in the drug trials they monitor. “DMCs play a critical role in the conduct of clinical trials by assessing the risks and benefits of an intervention as data accumulates, thereby enhancing the safety of trial participants,” the report says. “Although the fundamental principles of DMCs have been described, trials can present challenges for the DMC that are not anticipated or covered in the DMC statistical analysis plan. DMCs have to be prepared for the unexpected, relying in large part on their experience and collective wisdom.”

In most cases, the authors say, trials are completed as planned, with no DMC recommendation for early termination or major modification, but some trials have raised challenges for DMCs. The article includes summaries of “a few classic cases of early termination” and then addresses some recent cases to further illustrate the complexity of DMC responsibilities.