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

List of Authors

  1. Yemisrach Seralegne
    ,  
  2. Cynthia Khamala Wangamati
    ,  
  3. Rosemarie de la Cruz Bernabe ,  
  4. Ibrahim Mdala
    ,  
  5. Martha Zewdie
    ,  
  6. Hawult Taye Adane
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Abstract

Background

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.

Objective

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.

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 low-and middle-income countries (LMICs).

Corresponding author
Yemisrach Seralegne
Grant information

This project has received funding from the European and Developing Countries Clinical Trials Partnership programme under grant agreement No CSA2019ERC2680 (Improving post-trial access arrangements in clinical trials in sub-Saharan Africa [AccessAfrica]).

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright
© 2025 Yemisrach Seralegne (Corresponding Author, Co-Author); Cynthia Khamala Wangamati (Co-Author); Rosemarie de la Cruz Bernabe (Co-Author); Ibrahim Mdala (Co-Author); Martha Zewdie (Co-Author); Hawult Taye Adane (Co-Author) Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

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Amendment

We would like to forward our thanks to the reviewers who gave us their professional input as well as expertise-based comments on the previous version of the manuscript. Based on the given comments and direction we updated the content of the manuscript that helps us to strengthen the content as well as clearly describe the findings of the study to the readers. In this version of the article, we briefly describe and concise the content of the background and Introduction part, revise the objective, add recent references citation for strengthening the raised points, take correction on the spell of used words, briefly explain the search strategy, data management and analysis part, revise the discussion section and provide recommendation.

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Authors & roles

Yemisrach Seralegne

Clinical trial unit, Armauer Hansen Research Institute, Addis Ababa, 1005, Ethiopia

Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Norway, Oslo, 0450, Norway

Roles
Corresponding Author, Co-Author, Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Cynthia Khamala Wangamati

Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Norway, Oslo, 0450, Norway

Roles
Co-Author, Conceptualization, Data Curation, Formal Analysis, Methodology, Supervision, Writing – Review & Editing

Rosemarie de la Cruz Bernabe

Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Norway, Oslo, 0450, Norway

Roles
Co-Author, Conceptualization, Formal Analysis, Funding Acquisition, Supervision, Writing – Review & Editing
0000-0002-4999-3117

Ibrahim Mdala

Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway, Oslo, 0450, Norway

Roles
Co-Author, Data Curation, Formal Analysis, Software

Martha Zewdie

Clinical trial unit, Armauer Hansen Research Institute, Addis Ababa, 1005, Ethiopia

Roles
Co-Author, Conceptualization, Data Curation, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Hawult Taye Adane

Clinical trial unit, Armauer Hansen Research Institute, Addis Ababa, 1005, Ethiopia

Roles
Co-Author, Conceptualization, Data Curation, Formal Analysis, Software, Writing – Review & Editing
0000-0002-5604-9706

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