Registry name: Clinical Trials Registry – India (CTRI)
Year established: 2007
Points of interest:
- CTRI is hosted by the Indian Council of Medical Research at the National Institute of Medical Statistics in New Delhi.
- The CTRI is a primary registry with the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ensuring that all CTRI-registered trial results are adequately reported and publicly available.
- In June 2009, the Drugs Controller General of India (DCGI) mandated that all phase 1 through 4 clinical trials are CTRI registered.
- Editors of major biomedical journals in India only consider publishing the results of registered clinical trials.
- In 2017, the CTRI had 3,433 registered clinical trials, 73 percent of which used interventions.
- As of April 2018, the CTRI only registers clinical trials and observational studies prior to enrollment of the first patient.
- While clinical trial registration is required in India, results disclosure is not a requirement as of January 2019.
- Trials should be registered in the English language only, with no cost to register.
- For those registering clinical trials for the first time in India, the “new user” form will need to be filled out at www.ctri.nic.in to attain login credentials.
Related transparency research/articles:
- Clinical Trials Registry – India: An overview and new developments
- How to Register a Clinical Trial in India?
- Clinical trial registration: A practical perspective
- WHO Registry Profile
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