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Expanded Access Program: Navigating the When, Who and How

Every day, the biopharmaceutical company developing the drug receives calls requesting information on enrolling in the trials. They receive requests for direct and immediate access to the drug from patients who cannot participate in trial. The latter group of patients—those requesting access to the drug but who cannot participate in the trial—present a challenge for those in clinical drug development.

The purpose of this paper is to explore variables to be considered in developing a successful, well-managed EAP that provides access to investigational treatments to patients with terminal or severely debilitating disease and for whom commercially available treatment have failed. The EAP will provide access in a manner that:

 

  1. Does not threaten enrollment in or conduct of controlled clinical trials for the drug

  2. Meets all regulatory requirements

  3. Does not pose added risk to patient safety and

  4. Can be financially sustained

 

EAPs are not set up to support commercial objectives nor are they meant to support analysis or test a hypothesis, though sometimes the data have been very useful in a supplementary fashion.

White Paper: Navigating the When, Who and How of an EAP

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