Expanded Access Programs
Conducting an EAP, whether under a Treatment IND, Emergency Use Protocol, Compassionate Use or Named Patient Basis programs, requires specialized strategies, skills and resources different than a conventional clinical trial.
PACETM (Peri Approval Clinical Excellence) has the expertise, experience and infrastructure to help you navigate the complex regulatory and logistical issues of EAPs worldwide. By providing industry-recognized therapeutic experts, experienced project managers and clinical staff, PAXEXEL PACE has been instrumental in successfully executing EAPs in a broad range of indications throughout North America, Europe, and the Asia Pacific region. This experience includes the involvement in 44 EAPs, with more than 100,000 patients at sites across the globe. Six of these 44 EAPs were in several oncology indications. These oncology EAPs enrolled almost 50,000 patients in more than 3,900 sites worldwide. EAPs managed by PAREXEL include Worldwide Prescriber Use trials, Named Patient Basis programs, and Cohort Patients Basis programs.
Through a unique integrated structure, developed for the management of EAPs and built upon previous experience of local and international programs, PAREXEL provides critical strategies for the management of the sponsor's EAP study as follows:
- Enrollment monitoring and trend analysis, including the ability to manage spikes in enrollment/site activity due to media attention and data release
- Flexible management of timeline shifts necessitated by EAP program evolution
- The provision of information and metrics regarding site accrual and patient enrollment on a site-by-site basis
- Guidance on the selection of sites for EAP participation, including the feasibility and utilizing research naïve investigators based on protocol-specific treatment requirements
- Minimizing the impact of competing studies being conducted at participating EAP study sites through simplification (and automation) of study processes/procedures where possible
From conception to implementation, PACE can provide the knowledge necessary for supporting key decisions on:
- The regional differences in regulatory systems and medical practice
- What constitutes "demonstration of need"
- Consultation on the level of monitoring rigor needed for an EAP
- Insights into benefits/risks in each locale, including potential cost recovery
- Development of pricing strategies where appropriate
- Objective projections of physician interest, potential patient numbers and drug distribution
Conducting EAPs on a domestic or global scale requires highly efficient, cost-effective systems and procedures to maximize investment return. Moreover, given that participating physicians tend to not be professional investigators, efficiently supporting their diverse needs, while achieving the study objectives, is a key measure of EAP success. To achieve this, PACE utilizes its Program Coordinating Centers (PCCs) in the Americas, Europe and Asia to provide cost effective, centralized EAP management, regardless of program size or geographical reach. PACE can be a true partner in successfully fulfilling your strategic and operational goals in the conduct of EAPs or similar type programs.
For more information contact the PACE Group.