Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices

Area of Science:

• Medical Science
• Clinical Practice
• Regulatory Affairs

Background:

• Physician-patient communication is critical post-approval of new drugs and medical devices.
• Understanding expedited FDA approval pathways and limited evidence is essential.
• Physician reporting of adverse events is vital for comprehensive safety profiles.

Purpose of the Study:

• To investigate physician communication practices regarding new drugs and devices.
• To examine physician reporting of adverse events for post-market surveillance.
• To assess how FDA approval influences prescribing and device recommendations.

Main Methods:

• Survey of a national sample of 509 board-certified internists, cardiologists, and oncologists.
• Data collected on information sources, patient communication, and adverse event reporting.
• Survey conducted between October 2021 and September 2022.

Main Results:

• 76% of physicians reported FDA approval significantly influenced their decisions.
• Only 50% "usually" informed patients about surrogate measures in approvals.
• 52% "usually" informed patients about required postapproval safety trials.
• Two-thirds (66%) were likely to report adverse events to the FDA.

Conclusions:

• Physician communication about pivotal trial characteristics (endpoints, postapproval requirements) is inconsistent.
• Half of physicians reported discussing evidence quality with patients.
• Enhanced communication and adverse event reporting are needed for optimal clinical use.