Description
Abstract
Post-trial access (PTA) is the provision of the investigational product for clinical trial participants and the community after the trial ends. The implementation of PTA requires the inclusion of PTA plans in protocols and continuity in PTA plans from the trial planning stage up until its implementation. Even though it is one of the rights of research participants and the community, not sufficiently planned and implemented by most trials conducted in Sub-Saharan Africa.
PTA is well known in different countries, but its implementation relies on the rules and guidelines of each country. Brazil and Argentina are currently among the few where there are binding regulations to provide PTA, whereas in a few Low- and Middle-Income Countries (LMICS), such as Uganda, India, and South Africa, non-binding national guidelines support the provision of PTA.
In the in-depth interview process of data collection; a knowledge gap in understanding of PTA, lack of written legally binding agreement between the researcher and funder, legally binding guidelines in the country, weak ethical review system and regulatory bodies follow up on PTA implementation process are the main findings and identified gaps from study participants that represent IRB members, researchers and funders in sub-Saharan countries.
Training of Institutional Review Board members (IRB), researchers and funders; availability of written legally binding agreement between the researcher and funder; following strict research ethical review system and a written directive on follow up of PTA implementations by the regulatory bodies like Food and Drug Authority (FDA) will contribute a lot to maximize PTA implementation in Sub-Saharan countries.
Keywords: Post-Trial Access, researchers and trial participants
| Contact Geneva Health Forum | I would like to receive information about the GHF 2024 conference and other GHF activities / Je souhaite recevoir des informations sur la conférence GHF 2024 et d'autres activités du GHF. |
|---|
