Abstract

Title: Final Year UCSF Health Professional Students’ Knowledge and Perspectives about FDA Regulation: A Survey Study

Introduction: In U.S., the Food and Drug Administration (FDA) regulates approval of new drugs and medical devices. Clinician understanding of FDA’s approval and regulatory processes is important to ensure that they can effectively communicate the evidence and uncertainties regarding medical product safety and efficacy with patients. Previous research has demonstrated that physicians and pharmacists are unfamiliar FDA regulation. These foundational skills would be expected to be acquired in health professional training, but no studies have assessed students’ knowledge of FDA regulation and incorporation of these topics in their school’s curriculum.

Aims:

(1) To assess knowledge regarding FDA’s regulatory processes, principles of clinical research, and interpretation of evidence among final year students at University of California San Francisco (UCSF) Schools of Medicine, Pharmacy, and Nursing (FNP).

(2) To understand health professional students’ perspectives on their education about FDA’s regulatory processes within their curriculum.

Methods: All students in their final year of training for medicine, pharmacy, and family nurse practitioner school at UCSF were invited to complete an online survey. The survey was developed with input from medical students, experts on survey design in medical education research, and experts on FDA policy and clinical trial interpretation. Survey was pretested with two medical students and two pharmacy students in final year of training. The final 24-item survey consisted of questions derived from previous surveys and novel questions, which were divided into the following domains: curriculum, knowledge of FDA approvals, assessment of trial interpretation and demographics.

Results: Of the 333 students invited to complete the survey, 175 (52%) responded. Among respondents, 71% reported learning about FDA drug approvals, whereas 14% reported learning about FDA medical device approvals. Of those students, 90% described their teaching on FDA drug approvals as cursory or basic and 60% of students favored more or much more teaching on the topic. Similarly, 95% students described their teaching on FDA medical device approvals as cursory or basic, and 69% students favored more or much more teaching on the topic. Sixty percent students of incorrectly believed FDA approval for new drugs requires both statistically and clinically important results. Most students correctly identified and applied the research concepts of randomization, blinding, and controls for a hypothetical case of a new drug.

Conclusions: Health professional students have a limited understanding of FDA approvals and the quality of evidence presented in research studies. Students expressed interest in more teaching about FDA’s regulatory processes for both drugs and medical devices. Improving education on regulatory topics may improve health professional’s communication with patients regarding FDA-regulated medical products and inform clinical decisions.