Your Expanded Access programs, like everything else in life, will benefit from preparation
Pharmaceutical manufacturers entering Phase 2 and 3 clinical trials may wish to begin planning for Expanded Access (also known as a Compassionate Use or Early Access), under which certain patients may be eligible to receive an investigational therapy outside of clinical trials. When deciding to offer Expanded Access, there are several considerations: among them the supply of the drug (or other therapeutic), the complexities of manufacturing, and the expected duration of treatment. There can be significant interest on the part of physicians and patients regarding investigational drugs showing promising early clinical data. MedaSystems is pleased to offer a new white paper, entitled “Expanded Access in the United States: Planning and Management Considerations'', authored by John Langlands, Ph.D. The paper outlines the processes and resources needed in order to run an effective Expanded Access program, and is available on our website.
For pharmaceutical manufacturers, the first step towards offering Expanded Access is to publish a policy on the company website. Companies are not obliged to offer Expanded Access, but those who do, need to be transparent about how they decide individual cases, and offer clear instructions to physicians for submitting requests. In designing a policy, companies should consider the availability of drug supply, how cases will be evaluated in an ethical and timely manner, and how information will be received from physicians and stored. The process can be smoothed substantially using template documents, and by having tools to store information and communicate with physicians in a secure and compliant manner.
The MedaSystems Expanded Access software platform helps pharmaceutical manufacturers to implement and manage Expanded Access, by digitizing and streamlining the intake and evaluation process, providing insights into program uptake and request flow, and documenting the process in a system that complies with applicable regulations, such as 21 CFR Part 11. Our white paper provides a comprehensive overview of operational considerations around receiving requests and administering a program, and includes a sample checklist. We hope you find it helpful!