Post-trial access practices in conducted clinical trials for Malaria, Tuberculosis, and Neglected Tropical Diseases...

According to the Council of International Organizations and Medical Sciences (CIOMS) 2016, post-trial access (PTA) means ensuring that communities involved in research can benefit from the treatments, products, and knowledge developed during the study. Although laws and policies on PTA are still limited, the topic has recently gained attention as part of efforts to promote fair benefit sharing with low- and middle-income countries. In sub-Saharan Africa, where clinical trials have significantly increased over the past two decades, information on how PTA is planned and implemented remains scarce. This study examines how PTA was addressed in clinical trials for Tuberculosis (TB), Malaria, and Neglected Tropical Diseases (NTDs) conducted in the region between 2008 and 2019.

The study aims to identify gaps in PTA planning and arrangements implementation, and suggest strategies for improving access to trial interventions and knowledge post-research.

A quantitative, cross-sectional study was conducted, using a self- administered online questionnaire to assess the PTA planning and implementation practices of Principal Investigators (PIs), co-PIs, trial coordinators, and sponsors involved in clinical trials in malaria, tuberculosis and NTDs across sub-Saharan African countries. Of the 300 invited potential participants, 37 provided complete responses.

A large proportion (43%) of the study respondents did not provide PTA plans for TB, Malaria, and NTDs in clinical trials. The findings highlight an overall lack of formalized PTA policies and commitments in clinical trials for TB, Malaria, and NTDs in sub-Saharan Africa. Most of the study participants (70.3%) expressed the need for PTA training.

Although the study offers valuable insights into PTA planning and practices, its generalizability may be limited by factors such as geographical and disease focus, reliance on self-reported data, and stakeholder representation. Despite these limitations, the study underscores an urgent need for structured PTA policy training programs, stakeholder collaboration, and effective training. Its findings can serve as a foundation for further research and policy development to enhance PTA in low-and middle-income countries (LMICs).