Bringing more transparency to clinical trials

Published in The Hindu on June 18, 2009

Two years after the Clinical Trial Registry — India was started, the Drugs Controller General of India has now made it mandatory to register trials. All trials initiated after June 15 will have to comply with this requirement.

This landmark decision is going to change the way clinical trials are conducted in the country.

It is bound to make clinical trials more transparent and accountable.

About 300 trials are registered in the Indian registry, with 150 being registered this year alone.

And that means the details of the 300-odd trials are freely accessible to the public.

The compulsion

Drug companies have been known to conduct unethical trials, undertake them without the permission of the government, publish only favourable results from specific sites, not report negative results, re-publish positive results in several journals etc.

Apart from the academic and scientific importance of trial registration, the requirement will go a long way in helping the public, particularly those interested in enrolling as volunteers.

The benefits

The registry, which is freely accessible ( www.ctri.in), will help potential volunteers know more about the nature and prime objective of a trial, and if similar trials have been conducted in the past and the results thereof.

In short, it will help arm the public with information that the trial sponsors may not be comfortable about sharing with them.

A major hub

This is particularly useful to the public and other health workers as India has become one of the major hubs for clinical trials. The major criticisms that trials conducted in India are not up to international standards would soon be a thing of the past.

It is highly likely that unethical trials are never conducted, or at least difficult to conduct, people are aware of what the objective of the trial is, help them when they give informed consent while volunteering for a trial, and ensure that compensation is provided to volunteers if any harm occurs as a direct result of the trial.

Many of those volunteering for a trial may not be literate or computer savvy. But the trickle down effect of the registry, it is hoped, will benefit even these people.

There have been several major initiatives taken in the last few years to make clinical trials more transparent and drug companies more accountable.

The first one, taken in 2005, by the International Committee of Medical Journal Editors (ICMJE) will remain the landmark initiative.

Landmark initiative

The ICMJE, comprising a dozen journal editors, decided to publish only the results of trials that have been registered in the clinical trial registry.

The rationale was simple. Drug companies cannot afford to miss the chance of publishing their trial results by not complying with the ICMJE directive.

Within five months of the ICMJE decision, the U.S. registry, the biggest in the world, registered a 73 per cent rise in the number of new trials registered.

The WHO platform

The WHO started the International Clinical Trial Registry Platform (WHO ICTRP) and helped decide the basic and crucial elements that have to be disclosed by the trial sponsors. The ICTRP serves as a platform in which registries from many countries are linked.

The amendment of the U.S. Food and Drug Administration Act in December 2007 making it mandatory to register all trials tightened the grip further.

And finally, 11 Indian journal editors followed the ICMJE line and made trial registration mandatory for any paper to be considered for publication form January 2010.

But the latest initiative (mandatory registration) is surely the best to get all trials conducted in India closely scrutinised.

The government has made it mandatory to register trials in the Indian registry, if a trial is conducted here, even if it is already registered elsewhere.

“If a trial is done in India as part of a multi-country trial then it should be registered here even if it is registered elsewhere,” said Dr Prathap Tharyan, professor of psychiatry at the Christian Medical College, Vellore, India.

Dr. Tharyan is a member of the steering group of the Indian Clinical Trials Registry.

He was also a member of the erstwhile Scientific Advisory Group of the WHO International Clinical Trials Registry Platform (ICTRP).

According to an Editorial published in the Tropical Gastroenterology journal last year, registering trials before the first volunteer is recruited “will prevent discrepancies in reporting outcomes between trial protocols and published reports.”

Prime objective

Very often drug companies project secondary or unexpected findings from a trial as the prime objective.

This is done when the real objective turns out to be either negative or insignificant. But comparing the details of the trial with those provided in the registry will help reveal what the prime objective of the trial was.

Finally, it will help journal editors to know more about the trial from the registry which will help them take an informed decision whether or not to publish the trial results in their journals.

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