Paramasivan Sangeetha, Bhan Anant, Rodrigues Rashmi, Menon Usha
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Bhopal Hub, Sangath, India.
Lancet Reg Health Southeast Asia. 2024 Feb 2;22:100360. doi: 10.1016/j.lansea.2024.100360. eCollection 2024 Mar.
This Viewpoint presents an overview of trials methodology research (TMR) and the case for investing in TMR in India. Randomised controlled trials and other types of clinical research inform evidence-based medicine, but this endeavour is dependent on the quality of such research. TMR is aimed at improving the way in which clinical trials are designed, conducted, analysed, and reported. The evolution of TMR in countries like the UK has been nurtured through dedicated funding support. Similar funding opportunities for TMR in India will help optimise the ethical and methodological rigour of the growing number of trials conducted in India. Such funding could help initiate an interdisciplinary network of key stakeholders in India to lead on TMR priority-setting exercises so that methodological questions of relevance to India are addressed. The establishment of trials methodology hubs will enhance initiatives such as the disease-specific clinical trials networks being set up as part of the National Biopharma Mission in India. We posit that promoting and establishing TMR as a distinct field of study in India will ensure the improvement of our health research ecosystem and call on national and international funding bodies to initiate consultation, consensus building and ringfenced funding for TMR in India.
本观点文章概述了试验方法学研究（TMR）以及在印度投资开展TMR的理由。随机对照试验和其他类型的临床研究为循证医学提供依据，但这一工作依赖于此类研究的质量。TMR旨在改进临床试验的设计、实施、分析和报告方式。在英国等国家，TMR的发展得到了专项资金支持。在印度为TMR提供类似的资金机会，将有助于优化在印度开展的越来越多试验的伦理和方法严谨性。此类资金可帮助在印度发起一个由关键利益相关者组成的跨学科网络，以主导TMR优先事项确定工作，从而解决与印度相关的方法学问题。试验方法学中心的建立将加强诸如作为印度国家生物制药使命一部分而设立的特定疾病临床试验网络等举措。我们认为，在印度推动并确立TMR作为一个独特的研究领域，将确保我们的健康研究生态系统得到改善，并呼吁国家和国际资助机构就印度的TMR开展磋商、建立共识并提供专项资金。
