Health Affairs November 3, 2023
Clinical development programs for new drugs include an array of research conducted both before and after a drug’s initial approval by the Food and Drug Administration (FDA). Post-approval clinical trials may be conducted in new patient populations to support additional indications and to demonstrate long-term safety and efficacy, including impacts on overall survival or major health events.
Research beyond the trials required for initial FDA approval is a critical component of expanding accessible treatment options for patients. New indications, obtained by approximately a third of drugs, can reduce insurance-related barriers that patients face in accessing drugs for evidence-based off-label use. Furthermore, long-term outcomes data inform prescribing practices and clinical guidelines.
Drug manufacturers’ decisions to take on the risks and costs...
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