Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Sep 22;13(9):e075903.
doi: 10.1136/bmjopen-2023-075903.

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

Eric I Nebie  1   2   3 , Hélène N Sawadogo  3 , Peter van Eeuwijk  4   2 , Aita Signorell  4   2 , Elisabeth Reus  4   2 , Juerg Utzinger  4   2 , Christian Burri  4   2
Affiliations

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study

Eric I Nebie et al. BMJ Open. .

Abstract

Introduction: Digital health has gained traction in research and development, and clinical decision support systems. The COVID-19 pandemic accelerated the adoption of decentralised clinical trials (DCTs) as a mitigation and efficiency improvement strategy. We assessed the opportunities and challenges of a digital transformation in clinical research in sub-Saharan Africa from different stakeholders' perspectives.

Methods: A qualitative study, including 40 in-depth semi structured interviews, was conducted with investigators of three leading research institutions in sub-Saharan Africa and Switzerland, contract research organisations and sponsors managing clinical trials in sub-Saharan Africa. A thematic approach was used for the analysis.

Results: Interviewees perceived DCTs as an opportunity for trial efficiency improvement, quality improvement and reducing the burden of people participating in clinical trials. However, to gain and maintain an optimal quality of clinical trials, a transition period is necessary to tackle contextual challenges before DCTs are being implemented. The main challenges are categorised into four themes: (1) usability and practicability of the technology; (2) paradigm shift and trial data quality; (3) ethical and regulatory hurdles and (4) contextual factors (site-specific research environment and sociocultural aspects).

Conclusion: The transformation from a site to a patient-centric model with an increased responsibility of participants should be context adapted. The transformation requires substantial investment, training of the various stakeholders and an efficient communication. Additionally, commitment of sponsors, investigators, ethics and regulatory authorities and the buy-in of the communities are essential for this change.

Keywords: Clinical Trial; PUBLIC HEALTH; QUALITATIVE RESEARCH.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Challenges for decentralised clinical trials in sub-Saharan Africa.
See this image and copyright information in PMC

References

    1. Manyazewal T, Woldeamanuel Y, Blumberg HM, et al. . The potential use of Digital health Technologies in the African context: a systematic review of evidence from Ethiopia. NPJ Digit Med 2021;4:125. 10.1038/s41746-021-00487-4 - DOI - PMC - PubMed
    1. Banks MA. Core concept: in the wake of COVID-19, decentralized clinical trials move to center stage. Proc Natl Acad Sci U S A 2021;118:e2119097118. 10.1073/pnas.2119097118 - DOI - PMC - PubMed
    1. Petrini C, Mannelli C, Riva L, et al. . Decentralized clinical trials (Dcts): A few ethical considerations. Front Public Health 2022;10:1081150. 10.3389/fpubh.2022.1081150 - DOI - PMC - PubMed
    1. Rogers A, De Paoli G, Subbarayan S, et al. . A systematic review of methods used to conduct Decentralised clinical trials. Br J Clin Pharmacol 2022;88:2843–62. 10.1111/bcp.15205 - DOI - PMC - PubMed
    1. Grignolo A. The clinical trials transformation initiative (CTTI). Ann Ist Super Sanita 2011;47:14–8. 10.4415/ANN_11_01_04 - DOI - PubMed

Publication types