Considerations for Pre-Approval Access Programs for Patients

Expanded Access Programs EAPs

Considerations for Pre-Approval Access Programs for Patients

Designing and implementing expanded access programs (EAPs) requires a unique perspective and a breadth of services that span the product development process. Starting with the end in mind is critical to supporting patients’ access to therapy in the EAP and seamlessly transitioning those patients to commercial product. Here are some considerations for each segment of the product lifecycle.


  • Understand the global regulatory environment governing EAP implementation
  • EAP design and data collection: What are the important data collection considerations relative to efficacy and safety data?
  • Enrollment considerations: Could enrollment in the expanded access program impact the clinical trial?


  • Key stakeholders: How can early engagement among key stakeholders (clinical commercial and supply chain) optimize patient transition experience and prevent disruption of therapy?
  • Opportunity to gain understanding of the payer landscape and anticipate barriers to access
  • Consider site level requirements for IRB approval of Patient Assistance Program enrollment forms and optimize the sequence of the review and approval timeframe
  • Aggregation of fragmented data to support timely and transparent reporting

UBC is the only pharma services provider that can provide a holistic view and an all-encompassing plan for expanded access programs. UBC has brought this expertise to EAPs in numerous diseases states including HIV, oncology, cystic fibrosis, Alzheimer’s disease and other rare diseases. Our experts also managed the largest EAP ever conducted in the United States.

Aaron Berger, Project Director, will present, “Discovering the rational and best practices for implementing Expanded Access Programs” at Outsourcing in Clinical Trials – New England. Attend his presentation at 3:15 p.m. on September 16 or stop by booth 36 to chat with our team. You can also download a free supplement outlining how to build patient relationships through EAPs from the editors of FirstWord or contact us to discuss your questions about expanded access programs.