Coming soon: Clinical trials transparency

Big Funders Decide To Make Results Public
 

Some of the world's largest funders of medical research, including Indian 

Council of Medical Research (ICMR), UK Medical Research Council 

and international organisations like PATH and Bill and Melinda Gates 

Foundation, have decided to make public results of all clinical trials funded 

and supported by them.

This assumes significance as almost half of clinical trials go unreported currently. 

Moreover, the move will enhance access to crucial data which can be useful 

in advancement of medical research. The decision is part of an agreement on 

standards, framed by the World Health Organisation (WHO), signed by the 

agencies at the ongoing United Nations' World Health Assembly in Geneva. 

Health Minister J P Nadda and senior officials from the health ministry are 

attending the Assembly where delegates from health groups and civil society 

from across the world are present.

The research institutes and other funding agencies agreed to develop and implement 

policies within the next 12 months that require all trials they fund, co-fund, 

sponsor or support to be registered in a publicly-availa ble registry. They also agreed 

that all results would be disclosed within specified time-frames on the registry or by 

publication in a scientific journal.

“We need timely clinical trial results to inform clinical care practices as well as 

make decisions about allocation of resources for future research,“ said Dr Soumya 

Swaminathan, DG of ICMR. “We welcome the agreement of international 

standards for reporting time-frames that everyone can work towards.“

Most of these trials and their results will be accessible through WHO's International 

Clinical Trials Registry Platform, a unique global database of clinical trials that 

compiles data from 17 registries around the world, including the US' clinicaltrials.gov, 

the EU's Clinical Trials Register, the Chinese and Indian Clinical Trial Registries and many others.

Experts say unreported trial results leave an incomplete and potentially misleading 

picture of the risks and benefits of vaccines, drugs and medical devices, and can lead to 

use of suboptimal or even harmful products. A common registry is expected to solve this 

problem. “Research funders are making a strong statement that there will be no more 

excuses on why some clinical trials remain unreported long after they have been 

completed,“ said Dr MariePaule Kieny, Assistant Director-General for Health Systems 

and Innovation at WHO.

Source: The Times of India