Nanivadekar Arun S
Independent Medical Research Consultant, Mumbai, Maharashtra, India.
Perspect Clin Res. 2013 Jul;4(3):157-9. doi: 10.4103/2229-3485.115371.
Pre-occupation with randomized control trials as the basis of evidence-based medicine has increasingly shadowed other study designs over the last half a century. These include surveys, case-control studies, and case-cohort studies. They have the potential to overcome several ethical and cost constraints, but depend on the embedding of research in routine practice, emphasis on relevant but limited, accurate, and complete data, harnessing of information technology for this purpose, and epidemiological and statistical literacy among clinicians. Only then will it be possible to nurture and network research-oriented practices by therapeutic areas. Given these, the alternative study designs can pave the way to regulatory reforms that will ultimately benefit the discoverers, approvers and users of health-care tools.
在过去半个世纪里，将随机对照试验作为循证医学基础的这种执念，日益掩盖了其他研究设计。这些研究设计包括调查、病例对照研究和病例队列研究。它们有可能克服若干伦理和成本限制，但这取决于将研究融入常规实践、强调相关但有限、准确且完整的数据、为此利用信息技术，以及临床医生具备流行病学和统计学素养。只有这样，才有可能按治疗领域培育和建立以研究为导向的实践网络。鉴于这些情况，替代性研究设计可为监管改革铺平道路，而这最终将使医疗保健工具的发现者、审批者和使用者受益。
