Clinical Trials Registry – India

A registry for clinical trials conducted in India

Logo of Clinical Trials Registry, India

The Clinical Trials Registry – India (CTRI) is a national registry of clinical trials conducted in India. It is a platform for registering all clinical trials conducted in the country, ensuring transparency and accountability in the conduct of clinical research. The registry is maintained by the Indian Council of Medical Research (ICMR) and is hosted at the National Institute of Medical Statistics (NIMS), New Delhi.

History

The CTRI was launched on 20 July 2007, in response to the need for a comprehensive database of clinical trials in India. Prior to its establishment, there was no centralized system for registering clinical trials, which led to issues of transparency and duplication of research efforts. The registry was developed to address these concerns and to align with global standards for clinical trial registration.

Objectives

The primary objectives of the CTRI are to:

• Ensure that all clinical trials conducted in India are registered before the enrollment of the first participant.
• Improve transparency and accountability in clinical research.
• Facilitate the dissemination of information about ongoing and completed clinical trials to the public and the scientific community.
• Promote ethical research practices by ensuring that trials are conducted in accordance with national and international guidelines.

Registration Process

The registration process in the CTRI involves the submission of detailed information about the clinical trial, including the study design, objectives, methodology, and participant eligibility criteria. Researchers are required to register their trials prospectively, meaning before the enrollment of the first participant. The information submitted is reviewed for completeness and accuracy before being made publicly available on the CTRI website.

Importance of Registration

Registering clinical trials in the CTRI is crucial for several reasons:

• It prevents selective reporting and publication bias by ensuring that all trials, regardless of outcome, are documented.
• It provides a public record of trials, which can be used by researchers, policymakers, and the public to track research activities and outcomes.
• It enhances the credibility of research findings by demonstrating a commitment to transparency and ethical standards.

Challenges and Future Directions

Despite its successes, the CTRI faces challenges such as ensuring compliance with registration requirements and maintaining the quality of data submitted. Efforts are ongoing to improve the user-friendliness of the registry and to integrate it with other international registries to facilitate global research collaborations.

Related pages

• Indian Council of Medical Research
• Clinical trial
• Ethics in clinical research
• International Clinical Trials Registry Platform