Centre for Chronic Disease Control (CCDC), New Delhi, India.
Curr Opin Cardiol. 2009 Jul;24(4):295-300. doi: 10.1097/HCO.0b013e32832af21b.
To provide a broad perspective of contextual factors involved in the conduct of clinical trials in developing countries.
The quantity of research in developing countries continues to be inadequate, with clinical trials comprising a small fraction of the total research output. Most trials done in developing countries tend to be designed in developed countries and led by investigators in those nations. The main challenges in the conduct of trials in developing countries stem from the vulnerability of the populations due to illiteracy, poverty, limited research infrastructure, lack of sufficient numbers of experienced investigators and trained support personnel, and fragmented healthcare system.
There is a need to formulate and conduct trials to test treatments that are context-specific and socially relevant. With careful planning in advance and shared partnership among sponsors, host-country research practitioners, government agencies and the community, many of the challenges facing clinical trial research can be overcome over the medium to long term. This would enable conformity to contemporary guidelines in both letter and spirit and hopefully develop research questions addressing the needs of developing countries.
综述目的：提供在发展中国家进行临床试验所涉及的背景因素的广泛视角。
最新发现：发展中国家的研究数量仍然不足，临床试验仅占总研究产出的一小部分。大多数在发展中国家进行的试验往往是在发达国家设计的，由这些国家的研究人员主导。在发展中国家进行试验的主要挑战源于人口的脆弱性，这是由于文盲、贫困、有限的研究基础设施、缺乏足够数量的经验丰富的研究人员和训练有素的支持人员以及分散的医疗保健系统造成的。
总结：有必要制定和开展试验，以测试特定背景和社会相关的治疗方法。通过提前仔细规划，并在赞助商、东道国研究人员、政府机构和社区之间建立合作伙伴关系，许多临床试验研究面临的挑战可以在中长期内得到克服。这将使我们能够在形式和实质上符合当代指南，并希望提出解决发展中国家需求的研究问题。
