Making Expanded Access Programs Work For - Not Against - Your Trial Drug
Executive SummaryProviding an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say
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Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.
The number of requests to use investigational drugs outside of clinical trials has grown and FDA typically approves all requests, but advocates still insist the process is set up to fail patients.