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The role of the Clinical Trials Registry – India (CTRI)

Jun. 22, 2017

The Clinical Trials Registry - India (CTRI) is hosted at the National Institute of Medical Statistics in the Indian Council of Medical Research.

Launched in July 2007, the CTRI is a FREE online portal for the recording and publishing of information on clinical trials conducted in India.

The CTRI database benefits patients, social activists, parliamentarians, healthcare professionals, the pharmaceutical industry and healthcare policy makers. The CTRI is a key contributor to the monitoring of clinical trials in India.

India today and the role of the CTRI

Nowadays, all clinical trials involving human participants of any intervention are required to be registered in the CTRI before enrollment of the first participant.

Interventions include:

  • Drugs
  • Surgical procedures
  • Preventative measures
  • Lifestyle modifications
  • Devices
  • Educational or behavioral treatment
  • Rehabilitation strategies
  • Trials

The CTRI aims to improve the transparency of clinical trials and the accountability of those conducting them. The CTRI’s ultimate goal is to enhance public confidence in clinical trials in India by:

  • Improving the internal validity of trials
  • Conforming to universally accepted ethical standards
  • Monitoring all registrations to ensure the increase of voluntary disclosure of all items in the register
  • Reporting relevant results of registered trials to the relevant authorities

When a clinical trial is registered, full disclosure of trial data set items is compulsory. Cases where patient recruitment has begun or even been completed must be registered too.

A slow but steady increase in trial registrations

As in other Asian countries, training in conducting clinical research is not a part of medical education in India. This has contributed to a lack of awareness of the CTRI and the need to register clinical trials among researchers.

Clinical trial registrations with the CTRI have been slow, but clinical trial participation in India appears to be growing. The Indian government continues to promote clinical trial registry. As of June 2017, 8,775 clinical trials have been reported.

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