Positive response to registering clinical trials seen
Published in The Hindu on July 5, 2007
Registering clinical trial details, by those conducting the trials, in registries that are easily accessible by the public has come a long way. The determination of medical journal editors has prevailed over commercial and other interests of pharmaceutical companies.
Two years after the International Committee of Medical Journal Editors (ICMJE) made clinical trial registration mandatory to be considered for publication post July 1, 2005 in the 12 medical journals, the response to the policy “has been overwhelming.”
Now many other journals have embraced the same policy. It requires sponsors to register trials before the enrolment of volunteers could begin.
“The research community has embraced trial registration,” noted the Editorial in the latest issue of the British Medical Journal. “Three years ago, trial registration was the exception; now it is the rule.”
One month after the ICMJE made its stand clear in 2005, the number of registrations in the clinicaltrials.gov, the U.S. government registry, shot up from 13,153 to 22,714. And according to the journal, in April this year, the number of entries in the registry had touched the 40,000 mark. More than 200 entries occur every week!
India’s number
That 467 trials have been registered in the U.S. clinical trial registry, of which, 264 trials are currently recruiting volunteers is a proof that the ICMJE strictures have paid dividends.
The fact that trials undertaken by Indian institutions, not to mention multinational pharmaceutical companies, international organisations or foreign institutions are also listed in the U.S. registry is encouraging.
If it was feared that India would become a haven for unethical clinical trials and Indians would be used as guinea pigs, the list of trials posted in just one registry is encouraging.
Surely, there are more trials being done in India than what have been registered. After all, registration is not the only way to root out the problem.
Probably, the compulsion from ethics committee and institutional review boards will “…have an important role by mandating trial registration as a requirement for full ethics committee approval,” as the Editorial in the May 2006 issue of British Medical Journal points out.
The Indian Council of Medical Research (ICMR) has been working towards setting up a national clinical trial registry. “We are almost ready to launch the registry,” said Dr. Vasantha Muthuswamy, Senior Deputy Director General, ICMR. “It is undergoing a trial run.”
“The registry has six parameters more than what is required by the WHO,” she added. The Indian registry will be linked to the WHO clinical trail registry platform, a global network that will enable a single point access to information.
The WHO had last May called for all trials involving humans to be registered at their earliest stage of development.
The September 2004 Editorial in British Medical Journal highlights the need for registration: “Missing out on the chances of publishing favourable findings in prestigious journals by not complying with this [ICMJE] policy is undesirable for industry…”
But what in the first place makes the act of registering clinical trials so very important?
Cherry picked data
Journal editors have always been critical of sponsors reporting cherry-picked results of trials in journals, multiple reporting of the same results in different journals, and non-disclosure and concealment of negative results. These, the editors argued, made a strong case for registering trials. The need for bringing about greater transparency and accountability was long overdue.
Finally, sponsors of trials owe it to the public, particularly the volunteers, who participate in the trials. And as an article in British Medical Journal (January 2005) has rightly put it, “…Participants… are as much owners of that “proprietary” information as the companies.”
If the journals have been harping on the issue of transparency, pharmaceutical companies initially resisted the idea due to the morbid fear that putting out details of trials for free public access before the trails are completed would blunt their competitive edge.
The scandals
But the several high-profile scandals where pharmaceutical companies were penalised for selective reporting and concealment of negative results left them with little power to negotiate or stand up to the mounting pressure.
The landmark case when GlaxoSmithKline was forced by a U.S. lawsuit to disclose unfavourable results of the drug paroxetine was the turning point.
Registering trials was seen as a possible way for pharmaceutical companies to regain public confidence.
Result registration
Though trial registration has now gained acceptance, the battle is far from over. The ICMJE’s goal is now to get companies to provide full disclosure of trial results through result registration.
“Researchers should be aware that editors may consider more detailed deposition of trail results in publicly available registries to be prior publication,” cautioned the Editorial in the latest issue of British Medical Journal.
The noose appears to be slowly but surely tightening around the drug companies.
