Health Affairs December 12, 2024
Post-approval research on existing medicines has improved patient outcomes and addressed unmet medical needs. In oncology, post-approval improvements to drugs reflect indications for additional cancer types, testing of new combination therapies that may be safer or more effective, and clinical studies of patients underrepresented in the pivotal studies required for original drug approval. These can lead to treatment advancements substantially improving key health outcomes, including longer life (overall survival) and better quality of life.
Clinical studies after drug approval are especially important in cancer treatment, where drugs approved for one type of cancer, cancer stage, or patient population may also be effective in others, and post-approval clinical trials gather additional evidence about the treatment. This evidence collected after approval may...
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