Features

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The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial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.

GCP Questions, FDA Answers: Transfer of Study Records

August 12, 2019

The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is one such question and answer excerpted from the CenterWatch publication, GCP Questions, FDA Answers.