Post-Trial Access
Post-trial access (PTA) allows Sponsors to provide access to their investigational drugs for patients after the clinical trial has ended.
What options exist at the end of your trial for continued drug supply to patients?
In some countries, such as Brazil and Israel, there are defined, mandated regulatory requirements around post-trial access commitments.
In other countries, such as the US, providing post-trial access is a choice. Sponsors have a number of pathways they can consider.
WEP - Experts in Managing Post-Trial Access
WEP works closely with Sponsors to understand their unique clinical pipeline, trial activities, and overall goals for development and commercialization. We then advise on the best possible program, or combination of programs. We create bespoke solutions that may include any of the following:
- Post-Trial Access Programs
- Expanded Access Programs
- Roll-Over Studies
- Open-Label Extensions
- Long-Term Observational Studies
- Post-Approval Studies
What Program to Use
Our team will help you evaluate your options and determine the ideal solution. Factors that influence what post-trial access program, or programs, you should use include:
- Regulatory Requirements
- Patient Population
- Drug Supply
- Ethical Considerations
- Program Scope
- KOL Relationships
- Budget
- Data Collection
- Commercial Strategy
