Mash Robert, Fatusin Bolatito B, Madela-Mntla Edith, Butler Christopher
Division of Family Medicine and Primary Care, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town.
Afr J Prim Health Care Fam Med. 2025 Jul 25;17(2):e1-e8. doi: 10.4102/phcfm.v17i2.5062.
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.
本文概述了针对博士研究生或早期职业研究人员的临床试验的基本特征。世界卫生组织最近强调了开展更高质量临床试验的必要性，包括来自低收入和中等收入国家以及基层医疗的更多试验，更多地让患者和社区参与，以及采用创新的试验设计。在撒哈拉以南非洲，基层医疗研究人员需要超越准实验设计和前后对照设计，开展随机对照试验。本文描述了随机对照试验的关键方法学要求：假设、设计、设置、招募、随机化、样本量、干预、评估、结果、解释和外推。我们还讨论了尊重研究参与者、参与协作过程、具备适当治理和透明结果传播的伦理且组织良好的试验的各个方面。最后，我们概述了诸如阶梯楔形设计、临床试验网络和适应性平台设计等创新设计。
