Clinical Trials Registry – India: A decadal perspective
Mendu Vishnu Vardhana Rao, Mohua Maulik, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Jyotsna Gupta, Yashmin Panchal, Neha Yadav
CTRI, ICMR-National Institute of Medical Statistics, New Delhi, India
OBJECTIVE: To present a descriptive analysis of the clinical studies registered in the Clinical Trials Registry – India (CTRI) and deduce its impact.
METHODS: We searched the CTRI databease for all registered clinical studies from July 20, 2007 to May 31, 2018. Extracted data were analyzed in three time periods i.e., Periods 1, 2, and 3 based on the major activities and milestones of the CTRI. In addition, comparative registrations of the various Primary Registries of the WHO were compiled and registration policy of Indian journals with regard to trial registration assessed.
RESULTS: A total of 20,160 clinical studies were submitted to the CTRI in the designated study period. Of the registered 14,341 clinical studies, 10,485 (76.3%) were interventional trials which were either regulatory (n = 2004), academic non-regulatory (n = 3855), or those conducted as part of PG thesis (n = 4626) trials. Regulatory trials registration numbers varied according to the Indian regulatory scenario. PG thesis trial registrations showed a steep rise, although unlike regulatory trials, these were mostly retrospective registrations. CTRI registration numbers were comparable to that in other Primary Registries. Instructions to authors of 48% indexed Indian journals made a mention of trial registration.
CONCLUSIONS: The CTRI has a strong global presence and has enhanced the transparency of regulatory trials as well as academic research particularly thesis-based work. The latter is expected to help improve standard of research and prevent repetitive research. Additional support from Indian journal editors by strict implementation of prospective registration is crucial for increasing compliance by researchers.
Dr. Mendu Vishnu Vardhana Rao
ICMR-National Institute of Medical Statistics, New Delhi - 110 029
|How to cite this article:|
Rao MV, Maulik M, Juneja A, Adhikari T, Sharma S, Gupta J, Panchal Y, Yadav N. Clinical Trials Registry – India: A decadal perspective.Indian J Pharmacol 2020;52:272-282
|How to cite this URL:|
Rao MV, Maulik M, Juneja A, Adhikari T, Sharma S, Gupta J, Panchal Y, Yadav N. Clinical Trials Registry – India: A decadal perspective. Indian J Pharmacol [serial online] 2020 [cited 2023 Jan 27 ];52:272-282
Available from: https://www.ijp-online.com/article.asp?issn=0253-7613;year=2020;volume=52;issue=4;spage=272;epage=282;aulast=Rao;type=0