Call to make clinical trial data public(TH)

Call to make clinical trial data public(TH)

Context

ICMR makes it mandatory for companies, organisations to disclose outcomes

News

From April, companies and organisations that have registered for clinical trials in India will have to disclose the outcomes of their tests within a year of completing them

Current situation

Currently, all trials in India are registered on the Clinical Trials Registry — India (CTRI)

SC ruling

In 2013, the Supreme Court of India forbade fresh applications for clinical trials following a public interest litigation petition due to reports that there had been a high number of deaths among those registered for trials

• Proper mechanism: The court asked the government to set in place a proper mechanism to regulate trials
• This led to measures which required that compensation be paid to patients affected by trials and that there was audio-visual proof that participants had indeed consented to take part in a trial
• However, these requirements were later eased and a streamlined system is in place which, according to clinical-trial companies, is much more conducive to organising trials.

What is CTRI?

• The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics, is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007
• Initiated as a voluntary measure, since 15^thJune 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI)
• Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication
• Any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH is expected to register the trial in the CTRI before enrollment of the first participant
• Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI.