Policy of truth: the pursuit of clinical trial transparency

New Health Canada policies intend to improve access to medication research

Three years ago, the efficacy of antiviral medications Tamiflu and Relenza was called into question when a highly-publicized report suggested that the drugs’ benefits were overstated by Roche, their manufacturer. The report was the work of the Cochrane Collaboration, a non-profit that evaluates health care practices and clinical trials for the purpose of disseminating information.

This kickstarted a saga consisting of myriad reports and articles supporting or challenging the findings of the group. However, the group’s efforts to access information from the manufacturer were not met with open arms. When data was requested in 2009, Cochrane Collaboration reviewers were met with a drawn-out abstinence, resulting in intensified media scrutiny toward Roche.

Here in Canada, getting access to research reports remains difficult. Health Canada’s approval of medications is often based on research reports that are exceedingly difficult to obtain. This ultimately leaves patients, physicians, and independent researchers in the dark regarding evidence.

St. Michael’s Hospital Physician and University of Toronto Assistant Professor Dr. Nav Persaud spent five years struggling to access records of clinical trials for the morning sickness drug Diclectin. Following a long-winded endeavour, he was given access to reports that, upon his analysis, reaffirmed his position that the medication was ineffective at quelling nausea and vomiting.

Despite having published his findings in the peer-reviewed journal PLOS One, the amount of information he was able to disclose was limited due to a confidentiality agreement he was required to sign.

A recent Health Canada proposal may alter the current state of affairs. The proposed regulation calls for the release of detailed reports for new clinical trials and retroactive release of old reports based on demand.

Persaud placed emphasis on the crucial nature of the contents of the reports, saying, “This is information about the effects of medication — so how effective they are, how safe they are — that’s the sort of information that’s included in the detailed clinical study reports. This is information that anyone taking these medications should have access to,” Persaud said. “This is definitely information that doctors and patients should have and they need it to make informed decisions.”

Nevertheless, there are complications that emerge upon close inspection of the policy. Information with “ongoing commercial value” — the definition of which is not explicitly stated — can be withheld. This did not seem to rouse Persaud’s concerns, as he said, “Information that pharmaceutical companies submit to Health Canada includes technical information about the way medications are made. This is information their competitors would like but most other people wouldn’t benefit from having access to. So there might be some examples of information that pharmaceutical companies have a legitimate interest in keeping confidential.”

Persaud expressed more apprehension toward the provisions around projects that have not officially been completed. “There’s exception for ongoing studies and interim results. The sponsors of these studies — the pharmaceutical companies — they could describe any study as ongoing or any result as interim and so if they make that an exception, it could be a way around transparency… there may or may not be an actual plan to continue a study. If they haven’t decided they could just label it interim… So in the future… I hope that it’s not the case that sponsors of these studies stamp them all as interim because that would be a way around the regulation.”

Such reports are not written for a lay readership and this, Persaud hopes, may minimize the possibility of misinterpretation. “They are fairly technically written… so they’re not easy to analyze or interpret… realistically most people aren’t going to look at the raw clinical study report,” he said. “These documents can be ten thousand pages long… But these documents could lead to publications describing the results and those could be read by members of the public and reported in the newspapers.”

Facilitating access to vital information will likely eliminate some of the delays and red tape in which requests are currently shrouded. One may argue, however, that among the chief benefits the policy would impart is increased participation. After all, getting involved is likely less appealing if the sole benefactor is the drug company.

Health Canada is welcoming input from the public until May 26.

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