Health Professional Students' Knowledge About FDA Drug and Medical Device Regulation

Area of Science:

• Medical Education
• Regulatory Science
• Clinical Research

Background:

• Healthcare professionals frequently utilize Food and Drug Administration (FDA)-regulated drugs and medical devices.
• Understanding FDA approval processes and interpreting clinical trial data are crucial for informed patient care.
• Existing medical and pharmacy curricula suggest education on these topics, yet student knowledge has not been evaluated.

Purpose of the Study:

• To assess the knowledge of final-year health professional students regarding FDA regulation and the interpretation of clinical research evidence.
• To identify gaps in understanding of FDA approval requirements and clinical trial quality among future healthcare providers.

Main Methods:

• A 24-item survey was developed to self-assess student exposure to FDA approval processes, understanding of evidence requirements, and ability to interpret trial data.
• The survey was administered to all 333 final-year students across medical, pharmacy, and family nurse practitioner programs at the University of California San Francisco.
• Data were collected between January and April 2024 from 175 respondents (53% response rate).

Main Results:

• 71% of respondents received some teaching on FDA drug approvals, but 90% described it as basic or cursory, with 58% desiring more instruction.
• Only 14% reported any teaching on medical device approvals.
• Despite 38% rating their understanding of FDA drug approvals as moderate to excellent, only 3% correctly identified approval criteria, and 17% recognized the superiority of all-cause mortality endpoints.

Conclusions:

• Health professional students exhibit a limited grasp of the FDA approval process and the quality of evidence for new medical products.
• There is a clear need to enhance educational curricula on regulatory science and clinical trial interpretation.
• Improved education will better equip future clinicians in making evidence-based decisions and communicating effectively with patients about medical products.