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.
Expert contributors to the forthcoming February 2023 issue of ACRP’s Clinical Researcher journal caution that careful planning for patient retention efforts are still necessary to reap the benefits of recent, promising trends.
ACRP urges the FDA to, among other things, pay close attention to the intersection of parents’ and children’s rights when seeking consent or assent to participate in a clinical investigation.
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.