Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi

  • Tiwonge Kumwenda Mtande Centre for Bioethics in Eastern and Southern Africa (CEBESA), Kamuzu University of Health Sciences, Malawi.
  • Gonasagrie Nair Centre for Medical Ethics and Law (CMEL), Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
  • Stuart Rennie UNC Bioethics Center, Department of Social Medicine, University of North Carolina at Chapel Hill, USA.
Keywords: real world data; pragmatic clinical trials; research oversight; research participants; guidelines; research ethics committee; PRECIS-2 tool; HIV; antiretroviral treatment.

Abstract

Background

Pragmatic clinical trials generally rely on real world data and have the potential to generate real world evidence. This approach arose from concerns that many trial results did not adequately inform real world practice. However, maintaining the real world setting during the conduct of a trial and ensuring adequate protection for research participants can be challenging. Best practices in research oversight for pragmatic clinical trials are nascent and underdeveloped, especially in developing countries.

Methods

We use the PRECIS-2 tool to present a case study from Lilongwe in Malawi to describe ethical and regulatory challenges encountered during the conduct of a pragmatic trial and suggest possible solutions.

Results

In this article, we highlight the following six issues: (1) one public facility hosting several pragmatic trials within the same period; (2) research participants refusing financial incentives; (3) inadequate infrastructure and high workload to conduct research; (4) silos among partner organisations involved in delivery of health care; (5) individuals influencing the implementation of revised national

guidelines; (6) difficulties with access to electronic medical records.

Conclusion

Multiple stakeholder engagement is critical to the conduct of pragmatic trials, and even with careful stakeholder engagement, continuous monitoring by gatekeepers is essential. In the Malawian context, active engagement of the district research committees can complement the work of the research ethics committees (RECs).

Published
2022-10-05
Section
Case Report

Journal Identifiers


eISSN: 1995-7262
print ISSN: 1995-7270