Clinical Researcher

Revolutions of the “way things are” vs. “the way things should be” sort are happening everywhere in the clinical research enterprise—for example, in trial designs and technologies, in workforce training and development, in regulatory compliance, in data management, and in patient recruitment and retention.

In vitro diagnostic devices are regulated as medical devices in the United States, but the obligations to demonstrate diagnostic test reliability involve some unique study designs and study implementation technicalities worth reviewing.

Estimates about the size and composition of the U.S. principal investigator pool vary widely and are often based upon rather opaque sources. The authors of this article offer a new view on the topic.

While new regulations and incentives for sponsors may help, no negative actions have been taken in the FDA’s oncology review divisions in cases of sponsor failure to conduct more diverse trials, and vague diversity guidance continues to raise concerns.