PAs as principal investigators of FDA-regulated clinical trials.

ABSTRACT: A misconception exists that only physicians can be principal investigators for FDA-regulated human clinical trials such as interventional studies. This article reviews existing guidelines and dispels the notion that physician associates/assistants (PAs) cannot be principal investigators for clinical trials. Additionally, this article describes an implementation plan to correct the misconception and establish a reference for future PAs seeking the role of principal investigator in clinical trials.