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.
PTA programs help maintain treatment continuity for eligible patients while regulatory approval, reimbursement, or commercial availability is still pending.
What options exist at the end of your trial for providing 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.
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
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
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
Post-Approval Studies
Long-Term Observational 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
What Program to Use
Our team will help you evaluate your options and determine the ideal solution for continued patient access after a clinical trial ends. In some cases, Sponsors can utilize a single access pathway. In other cases, a combination of programs should be used to support patients responsibly while maintaining regulatory compliance and operational control.
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
Post-Trial Access Articles
Post-Trial Access FAQs
What is Post-Trial Access (PTA) in clinical trials?
Post-Trial Access (PTA) refers to a pathway that allows eligible patients to continue receiving an investigational medicine after their participation in a clinical trial has ended. PTA may be requested when patients are still benefiting from treatment, but the product is not yet commercially available.
For Sponsors, PTA planning helps maintain continuity of care while addressing ethical, regulatory, operational, and supply considerations after study close-out. WEP Clinical helps Sponsors design practical PTA strategies tailored to country requirements and patient needs.
Are Sponsors required to provide PTA after a clinical trial?
PTA requirements vary by country, protocol, ethics committee expectations, and local regulations. In some cases, Sponsors may be legally or ethically expected to continue treatment for patients who are benefiting from an investigational medicine after a clinical trial ends. In other situations, PTA may be voluntary but still important for patient continuity and stakeholder trust.
Sponsors should assess PTA obligations early, including regulatory pathways, product supply, safety reporting, and treatment discontinuation planning. WEP Clinical helps Sponsors navigate these requirements across different countries.
When should Sponsors start planning for PTA?
Sponsors should start planning for PTA as early as possible, ideally during protocol development or before pivotal trial close-out. Early PTA planning helps avoid delays, supply gaps, site confusion, and treatment interruption for patients who may request continued access after the study ends.
Planning should include country requirements, patient eligibility, regulatory routes, supply strategy, pharmacovigilance, site communication, and discontinuation criteria. WEP Clinical supports Sponsors with early PTA strategy so access pathways are ready before patients reach the end of a clinical trial.
What are the different options for providing PTA?
PTA can be provided through several routes depending on the country, product status, patient population, and Sponsor objectives. Options may include an Open Label Extension study, Expanded Access Program, Compassionate Use Program, Named Patient Program, direct supply route, or transition to commercial access where available.
The right pathway depends on whether further data collection is needed, whether the product is approved locally, and what local regulations allow/mandate. WEP Clinical helps Sponsors assess the most appropriate PTA model for each country, patient group and the Sponsor’s goals.
How do Sponsors manage PTA across multiple countries?
Managing PTA across multiple countries requires a country-by-country strategy because regulatory requirements, access pathways, timelines, documentation, and import rules can vary significantly. Sponsors need to align patient eligibility, site communication, physician requirements, supply planning, safety reporting, and local approvals across each market.
A single global approach is rarely enough. WEP Clinical helps Sponsors coordinate global PTA programs by mapping local requirements, identifying practical access routes, managing stakeholders, and supporting treatment continuity for eligible patients across different countries.
How are safety, pharmacovigilance, supply, and treatment discontinuation managed in PTA?
PTA programs should include clear processes for safety reporting, pharmacovigilance, product supply, resupply, and treatment discontinuation. Sponsors need defined responsibilities for adverse event reporting, investigator communication, product accountability, import requirements, and patient transition or discontinuation criteria.
These elements are especially important when patients continue treatment outside a traditional clinical trial setting.WEP Clinical helps Sponsors build structured PTA programs that maintain safety oversight, support reliable supply, and provide clear guidance for sites, physicians, and patients throughout the post-trial access period.
Post-Trial Access Case Studies
Get in Touch
If you are a Sponsor and you would like to discuss your options for providing post-trial access, please complete the form to the left or contact us at:
We typically respond in under 24 hours.
Acting as a strategic Access Program partner – Going beyond the standard vendor approach
Serious Pulmonary Conditions Phase 3