Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices
Among 509 board-certified internists, cardiologists, and oncologists, half reported telling patients when drugs or medical devices were approved based on surrogate measures and when there was an FDA-mandated postapproval trial to further evaluate safety and effectiveness.As drugs and medical devices are increasingly approved by the FDA through expedited pathways based on data with lingering uncertainties, discussion with patients about issues such as the nature of the endpoints assessed and existence of postapproval testing requirements can help inform patient decision making.
Authors
- Sanket S. Dhruva (ORCID: https://orcid.org/0000-0003-0674-2032)
- Steven Woloshin (ORCID: https://orcid.org/0000-0003-2311-1005)
- Jonathan J. Darrow (ORCID: https://orcid.org/0000-0002-7351-4243)
- Robin Z. Ji
- Aaron Seth Kesselheim (ORCID: https://orcid.org/0000-0002-8867-2666)
- Rita F. Redberg (ORCID: https://orcid.org/0000-0001-6281-0250)
- Zhigang Lu
Institutions
- Dartmouth Institute for Health Policy and Clinical Practice (US)
- Brigham and Women's Hospital (US)
- San Francisco VA Medical Center (US)
- Harvard University (US)
- Lee University (US)
- University of California, San Francisco (US)
Publication Details
- Journal
- Medical Decision Making
- Published
- 2024-12-21
- DOI
- https://doi.org/10.1177/0272989x241302096
- Citations
- 1
- Primary Topic
- Pharmaceutical industry and healthcare
- Type
- article
- Field-Weighted Citation Impact
- 0.47
Funders
- Greenwall Foundation
- Arnold Ventures