Clinical trial methods for family medicine and primary care

African Journal of Primary Health Care & Family Medicine

 
 
Field Value
 
Title Clinical trial methods for family medicine and primary care
 
Creator Mash, Robert Fatusin, Bolatito B. Madela-Mntla, Edith Butler, Christopher
 
Subject Family medicine clinical trials; randomised controlled trial; experimental studies; study design; adaptive platform design; methodology; methods; primary care.
Description This article outlines the essential features of clinical trials for doctoral or early career researchers. The World Health Organization has recently emphasised the need for higher quality clinical trials, more trials from low- and middle-income countries, as well as primary care, more engagement with patients and communities and adoption of innovative trial designs. In sub-Saharan Africa, primary care researchers need to move beyond quasi-experimental and before-and-after designs to conduct randomised clinical trials. The article describes the key methodological requirements of a randomised controlled trial: the hypothesis, design, setting, recruitment, randomisation, sample size, intervention, assessment, results, interpretation and extrapolation. We also discuss the aspects of ethical and well-organised trials that respect study participants, engage with collaborative processes, have appropriate governance and transparent dissemination of results. Finally, we outline innovative designs such as step-wedge, clinical trial networks and adaptive platform designs.
 
Publisher AOSIS
 
Contributor Funding from NIHR grant at UCT for APCs
Date 2025-07-25
 
Type info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion — Randomised controlled trial
Format text/html application/epub+zip text/xml application/pdf
Identifier 10.4102/phcfm.v17i2.5062
 
Source African Journal of Primary Health Care & Family Medicine; Vol 17, No 2 (2025); 8 pages 2071-2936 2071-2928
 
Language eng
 
Relation
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:

https://phcfm.org/index.php/phcfm/article/view/5062/8457 https://phcfm.org/index.php/phcfm/article/view/5062/8458 https://phcfm.org/index.php/phcfm/article/view/5062/8459 https://phcfm.org/index.php/phcfm/article/view/5062/8460
 
Coverage — — —
Rights Copyright (c) 2025 Robert Mash, Bolatito B. Fatusin, Edith Madela-Mntla, Christopher Butler https://creativecommons.org/licenses/by/4.0
ADVERTISEMENT

International Tel: 021 975 2602

15 Oxford street, Durbanville, Cape Town, 7550 (South Africa)
Copyright © AOSIS (Pty) Ltd. All rights reserved.
No unauthorised duplication allowed