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PAs as principal investigators of FDA-regulated clinical trials

Colleen Elizabeth Gosa Nalepinski1

  • 1Colleen Elizabeth Gosa Nalepinski is decentralized clinical trials director in research nursing and phlebotomy solutions at IQVIA in Durham, N.C.; a clinical assistant professor at Marquette University in Milwaukee, Wisc.; and a principal investigator at Spaulding Clinical Research in West Bend, Wisc. The author has disclosed no potential conflicts of interest, financial or otherwise.

JAAPA : Official Journal of the American Academy of Physician Assistants
|April 7, 2023
PubMed

Insights

Physician Associates/Assistants (PAs) can serve as principal investigators in FDA-regulated clinical trials, challenging a common misconception. This article clarifies guidelines and provides a plan to support PAs in this crucial research role.

Area of Science:

  • Clinical Research
  • Regulatory Affairs
  • Medical Practice

Background:

  • A prevalent misconception suggests only physicians can lead FDA-regulated clinical trials.
  • This limits the potential pool of qualified principal investigators.

Approach:

  • This article systematically reviews current FDA guidelines and relevant literature.
  • It analyzes the regulatory framework governing PI eligibility for human clinical trials.
  • An implementation strategy is proposed to address and rectify the existing misconception.

Key Points:

  • Physician Associates/Assistants (PAs) are legally and ethically qualified to serve as Principal Investigators (PIs) for FDA-regulated clinical trials.
  • Existing guidelines do not restrict PI roles exclusively to physicians.
  • Clarifying these guidelines empowers PAs to pursue and excel in PI positions.

Conclusions:

  • Physician Associates/Assistants are qualified to be principal investigators in clinical trials.
  • Addressing this misconception will broaden access to clinical research leadership.
  • Implementation of a support plan is recommended for PAs pursuing PI roles.

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