The Canadian government announced plans yesterday to establish a Web-based list of all clinical trials conducted in Canada. Such a nationwide registry would create a centralized source of information for patients to find studies they can join and for drugmakers to identify trial participants. However, critics charge that the initiative may do little to increase transparency and accountability in the reporting of clinical research results.

“I find it somewhat cynical that here the government is supporting a website to encourage participation in clinical trials when they allow the companies to keep that information proprietary,” says Alan Cassels, a pharmaceutical policy researcher at the University of Victoria in British Columbia. “It’s hypocritical and it’s crass.”

Currently, only trials funded by Canadian taxpayers or conducted at hospitals that receive public funds must be listed on a trial registry. (With no Canada-specific repository, such studies can be listed on any registry that is compliant with certain criteria set by the World Health Organization or the International Committee of Medical Journal Editors, including the US government’s clinicaltrials.gov, the UK-based Current Controlled Trials International Standard Randomised Controlled Trials Number Register and more than a dozen other national registries around the world.)

Drug company-sponsored trials, in contrast, carry no such mandate. South of the border, US law requires that trial investigators publically release protocols and results for all experimental drugs and devices on clinicaltrials.gov, including for privately funded trials. But in Canada, drugmakers have no obligation to publically disclose study data or register their trials—and, to many researchers’ chagrin, the announcement this week from Health Canada makes no mention of plans to change that.

Without a mandatory disclosure requirement, Kay Dickerson, director of the Center for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health in Baltimore, worries that the proposed Canadian registry will do little to actually increase access to information for both patients and medical professionals. “If it’s voluntary that you register the trials it’s unlikely that you’re going to get 100% ascertainment,” she says.

Hardly registered

Matthew Herder, a health law researcher at Dalhousie University in Halifax, Nova Scotia, has been one of the most vocal advocates of a mandatory reporting requirement. In a letter sent to the Canadian Senate’s Standing Committee on Social Affairs, Science and Technology in June 2012, Herder and two colleagues argued against a “labor-intensive, time-consuming and costly” Canadian portal like the one being proposed, calling instead for Canadian trial sponsors to use a limited number of the already established websites.

“What’s needed is a stronger commitment to enforcing the requirement that people conducting clinical trials actually register in those existing registries,” Herder told Nature Medicine.

Nothing is finalized in the government’s plan. According to the press release from Health Canada, stakeholders will be able to weigh in on the proposal once it is ready, which is expected in the coming months. Still, most onlookers aren’t expecting much.

“We have a staggeringly opaque system here,” says Michael McDonald, a bioethicist at the University of British Columbia in Vancouver. “I applaud anything that brings some semblance of transparency, but I don’t just want it to be window-dressing.” He adds, “The devil is in the details.”

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