Post-trial access practices in conducted clinical trials for Malaria, Tuberculosis, and Neglected Tropical Diseases (NTDs) across Sub-Saharan African countries: A quantitative study.

Abstract

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." 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).Although the number of clinical trials conducted in the Sub Saharan (SSA) countries has increased in the past two decades, plans and practices for PTA are underreported. The study examines PTA planning and implementation in clinical trials focused on Tuberculosis (TB), Malaria, and Neglected Tropical Diseases (NTDs) in Sub-Saharan African countries, conducted between 2008 and 2019.

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

Method: 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.

Findings: 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.

Conclusion: 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 LMICs.