Expert Committees Need Expert Management

September 8, 2019

As sponsors and CROs make increasing use of expert committees — especially Endpoint Adjudication Committees (EAC) and Data Monitoring Committees (DMC), they are asking, “What makes an expert committee successful?”

Putting Placebo Response in Its Place

August 26, 2019

The best approach to mitigating placebo response is to develop a strategy that has all participants measuring the same things in the same way, two experts say.

Industry Seeks More Detail from FDA Guidance on Trial Diversity

August 19, 2019

The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial organizations and patients responding to the agency’s call for comments on the document.