George Bobby
AVP and Head Regulatory Affairs, Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, Rabale, Navi Mumbai, India.
Perspect Clin Res. 2012 Oct;3(4):122-4. doi: 10.4103/2229-3485.103592.
A clinical trial registry (CTR) is an official platform for registering a clinical trial (CT) with an objective of providing increased transparency and access to CTs to the public at large. Clinical Trials Registry - India (CTRI) is a free online public record system for registration of CTs being conducted in India. The vision of the CTRI is to ensure that every CT conducted in the region is prospectively registered with full disclosure of the trial data set items. With more number of CTs being conducted in the country, with a large number being global multicentre trials, it is binding on the industry/investigators/sponsor to comply with the requirements laid down. While there are pros and cons, there is enough scope for improvement of CTRI.
临床试验注册库（CTR）是一个用于注册临床试验（CT）的官方平台，其目的是提高透明度，让广大公众能够获取临床试验信息。印度临床试验注册库（CTRI）是一个免费的在线公共记录系统，用于注册在印度开展的临床试验。CTRI的愿景是确保该地区开展的每项临床试验都能进行前瞻性注册，并全面披露试验数据集项目。随着该国开展的临床试验数量增多，其中大量是全球多中心试验，行业/研究者/申办者有义务遵守规定的要求。虽然有利有弊，但CTRI仍有很大的改进空间。
