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Clinical Trials Registry - India: An overview and new developments
M Vishnu Vardhana Rao1, Mohua Maulik1, Jyotsna Gupta1
1Clinical Trials Registry - India, ICMR-National Institute of Medical Statistics, New Delhi, India.
Indian Journal of Pharmacology
|December 4, 2018
Summary
The Clinical Trials Registry - India (CTRI) is updating its policies to require prospective registration only from April 1, 2018. Future updates will include structured summary results disclosure for interventional trials.
Area of Science:
- Clinical research and trial management
- Public health informatics
- Regulatory affairs in medicine
Background:
- The Clinical Trials Registry - India (CTRI) has been a key platform for over a decade.
- It serves as a free, searchable online database for clinical trials in India and other nations.
- CTRI accommodates various clinical studies, including postgraduate theses.
Purpose of the Study:
- To evaluate the current status and recent advancements of the CTRI.
- To inform stakeholders about upcoming changes in trial registration policies.
- To highlight the CTRI's role in enhancing clinical trial transparency.
Main Methods:
- Review of CTRI's operational history and policy documents.
- Analysis of the transition from dual to prospective-only registration.
- Examination of planned enhancements for results disclosure.
Main Results:
- CTRI is shifting to prospective-only trial registration starting April 1, 2018.
- Only trials without prior patient enrollment will be accepted post-transition.
- Structured summary results disclosure for interventional trials is forthcoming.
Conclusions:
- The CTRI is evolving to enhance the quality and transparency of clinical trial data.
- The move to prospective registration aligns with global best practices.
- Future results disclosure will improve data accessibility and research integrity.
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