Post-trial access practice in malaria, tuberculosis, and NTDs clinical trial studies across Sub-Saharan African countries, A quantitative study

<ns3:p>Background According to the Council of International Organizations and Medical Sciences (CIOMS) 2016, post-trial access (PTA) refers to the ethical imperative that requires the sponsor, researchers, and relevant public health authority, "to make available as soon as possible any intervention or product developed, and knowledge generated, for the population or community in which the research is carried out." PTA is stipulated and recommended by different international research guidelines like CIOMS, and it was acknowledged that PTA should be accessible to those who actively participated in the trial study and the community and/or host country. Law, policy, and practical guidance for PTA has so far been vague but has recently attracted and increased attention in the context of benefit sharing of scientific research results with low- and middle-income countries (LMICs). Even though the number of clinical trials conducted in the Sub-Saharan (SSA) countries has increased in the past two decades, PTA plan and practice is underreported or very low. Objective To evaluate PTA plan and implementation practice on TB, Malaria and Neglected Tropical Diseases (NTDs) clinical trial studies conducted in the sub-Saharan African countries. Method A quantitative, cross-sectional study, using a self-administered online questionnaire was used to evaluate the PTA plans and practices of Principal Investigators (PIs), trial coordinators, and sponsors in Sub-Saharan African countries. Findings Nearly half of the study respondents did not provide PTA plans for TB, Malaria, and NTDs in clinical trials. Most of the respondents indicated a need for training on post-trial access. Conclusion PTA training should be prepared and facilitated for researchers, IRB members, PIs, funders, and sponsors; discussion and arrangement on PTA should be done before the conduct of the trial; and there should be written agreement between the parties to guarantee PTA to study participants and community after the end of the trial study.</ns3:p>