Clinical Trials Registry – India

Clinical Trials Registry – India (CTRI) is a free and online public record system for registration of clinical trials being conducted in India. It was launched on 20th July 2007 by the Indian Council of Medical Research (ICMR) in collaboration with the Department of Science and Technology (DST), Government of India. The registry aims to bring transparency, improve the credibility of, and ensure that the clinical trials conducted are in accordance with the ethical guidelines. The CTRI is hosted at the National Institute of Medical Statistics (NIMS), ICMR, New Delhi.

Overview

The primary objective of the CTRI is to ensure that every clinical trial conducted in the region is registered, thereby promoting transparency and accountability in clinical research. The registry provides a platform for the public to access information about the clinical trial activities across the country, including trial objectives, sponsor details, research sites, and the status of the trial. This initiative is in line with the global movement towards trial registration, aiming to prevent selective reporting of trials and ensure that trials do not duplicate unnecessarily.

Registration Process

The registration process in CTRI is designed to be comprehensive and requires detailed information about the trial. This includes scientific and ethical aspects of the study, such as the study design, target participant details, interventions, and outcomes. The registry mandates the registration of clinical trials before the enrollment of the first participant. This proactive approach ensures that all trials are accounted for from their inception.

Compliance and Enforcement

Compliance with CTRI registration has been made mandatory by the Drugs Controller General of India (DCGI) for all clinical trials conducted in the country. This mandate is aimed at enhancing the ethical standards and transparency of clinical research in India. Non-compliance with the registration requirement can lead to the rejection of trial results by regulatory authorities and journals.

Impact

Since its inception, the CTRI has significantly contributed to increasing the visibility and transparency of clinical trials conducted in India. It has facilitated the tracking of trials and their outcomes, thereby aiding in the prevention of selective reporting and publication bias. The registry has also played a crucial role in ensuring that clinical trials are conducted in accordance with ethical guidelines and regulatory requirements.

Challenges

Despite its successes, the CTRI faces challenges such as ensuring the completeness and accuracy of trial registrations. There is also a need to enhance awareness among researchers and institutions about the importance of trial registration and compliance with the registry's requirements.

Future Directions

The CTRI aims to continuously improve its platform and processes to better serve the needs of stakeholders in the clinical research community. This includes enhancing the user interface, expanding the registry's functionalities, and strengthening collaborations with international trial registries to promote global data sharing and transparency in clinical research.