Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the Clinical Trials Registry India (CTRI). Here is an overview of this registry:
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
TrialAssure® Registry can automate the disclosure of clinical trial results for the Clinical Trials Registry India (CTRI). For questions or a free demo, email firstname.lastname@example.org