Post-Trial Responsibilities

Post-Trial Responsibilities

Post-Trial Responsibilities (PTR) are the ethical and practical obligations owed to participants after their active involvement in a clinical trial ends, as well as to the countries and communities that host these research sites. These responsibilities are shared amongst stakeholders across the clinical research ecosystem, including sponsors, investigators, funders, healthcare providers, and payers. 

To support the ethical implementation of post-trial continued access to the investigational product for participants, the MRCT Center has developed practical guidance and resources, including revised principles with accompanying analysis, a framework of responsibilities for continued access to investigational medicines, and a framework for significant risk devices after a clinical trial.

The Center also leads efforts to define ethically appropriate alternatives when durable commercial access is not feasible after a trial is over and to establish a framework for determining when and how those alternatives should be provided to host countries and communities.

Why is this work important?

Research participants deserve consideration of continued access to an investigational product to which they have received benefits as part of a clinical trial.

International ethical guidelines, including the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS) discuss the responsibilities stakeholders have to provide continued access to investigational products. Notably, in 2024, paragraph 34 of the Declaration of Helsinki was revised to reflect the responsibilities that sponsors and researchers have to plan for post-trial provisions and the role research ethics committees play in approving exceptions.

Post-Trial Provisions

34. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent. 

World Medical Association. (2024). WMA Declaration of Helsinki: Ethical principles for medical research involving human subjects

There is no guidance or instruction on fulfilling the responsibilities set forth in the Declaration of Helsinki and CIOMS. To fill this gap, the MRCT Center convened a group of experts to develop and put forth actionable and practical tools to help sponsors and researchers understand their ethical responsibilities and how to achieve them practically. We have developed a series of resources, including principles, frameworks, recommendations, and case studies.

Continued Access to Investigational Products

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Continued access can be defined as the continued provision of the investigational medicine or continued maintenance of the investigational significant risk device for any clinical trial participant after participation in the trial. Some investigational interventions may require unique supportive care that should be considered by the sponsor, researcher, healthcare systems, or host country governments. Post-trial, continued access is a shared responsibility and should be determined before the trial begins.

The PTR task force developed a revised set of principles with associated analysis and a framework of responsibilities for continued access to investigational medicines and a framework for significant risk (SR) devices after a clinical trial: scenarios that require further consideration.

Project Tools:

Obligations to host communities and countries

In late 2025, the Center launched an initiative to re-examine post-trial obligations to host communities or countries where trials are conducted, beyond obligations already owed to trial participants. In general, sponsors fulfill these obligations with the intent of commercializing the investigational product in those countries where trials had been sited and providing durable access to the product. When commercialization is not feasible, however, are there commensurate sponsor obligations to the host communities and countries? What is the alternative to commercializing and marketing the investigational product in these situations?

The work stream explores the circumstances that challenge the ability to achieve durable access in a country or community where a trial may be conducted, and the possibility of reciprocal benefits when durable access is not, or will not be, realistic.

The task force has been actively developing a decision-making framework to guide sponsors through these challenging scenarios. Later this year, additional subject matter experts will be invited to join as reference groups to stress-test and refine the framework before it is finalized.

Questions this project aims to answer include:

• What circumstances legitimately challenge durable access, and when is it appropriate to offer an alternative to commercial access?
• Which stakeholders need to participate in decision-making? And when?
• What counts as an acceptable alternative? How do we ensure that the alternative offered delivers actual value to host communities and countries?

Resources: Post-trial Responsibilities