Any day now, the Canadian government is going to announce a website that federal health minister Leona Aglukkaq is calling a coup for transparency and patient access. The soon-to-be-launched database of clinical trials happening in Canada will go live before the end of May, which means Canadians will soon have a one-stop shop for information about what pharmaceutical products are being tested on humans in this country.
Before your eyes glaze over at what sounds like a regulatory snooze fest, know that how our government regulates clinical trials impacts anyone who uses or prescribes pharmaceuticals. It also affects all those brave souls who give their bodies over to science in the hope that they’ll not only get help with an ailment, but also contribute to the advancement of knowledge about treatments and human health.
Right now, it’s estimated that about half of all trials run globally never see the light of day. This is because scientists—both independent and those working for the pharmaceutical industry—are more inclined to publish studies about drugs that have positive results, a phenomenon known aspublication bias. As Sir Iain Chalmers, a British researcher and one of the founders of the Cochrane Collaboration, asked, “How many (patients) would have agreed to participate (in a trial) if researchers had told them, ‘If the results of this trial don’t serve our academic or commercial interests we won’t make them public?’”
To rectify this situation, governments around the world have been requiring researchers to register trials on international registries—or face fines. Australia and the U.S. require the registration of trials. So do India and Brazil. In Europe, the Medical Research Council mandated trial registration in the 1990s. Taking transparency even further, Europe should soon start publishing anonymous patient-level data from trials on these registries so that, if anyone questions the truth of published research, they can go back to the raw data to double-check findings for themselves.
These measures were supposed to bring to the clinical studies process some independent oversight, which is currently lacking. Just consider the fact that when you buy a new SmartPhone or blender for your kitchen, you can be sure it was vetted for safety by an independentorganization. Not so for the medicines you use. Testing is often done by the manufacturer of a new drug; studies from those tests are then provided to health regulators at the discretion of the manufacturer.
When the news about Canada’s trial website was first announced in October, the research community was eager to see what Health Canada was planning. But as researchers pointed out back then, the site seems to lag behind other countries on the transparency front. Now, with the impending launch, there are more detailsavailable: Health Canada says it will publish information about the drug, the medical condition, and the study population that’s being tested in every trial authorized to run here as of April 1, 2013. The database will also include the name of the company or institution that is running the trial, as well as the Health Canada control number, and the start and end date of the clinical trial, if known.
Science-ish took the update to experts to see what they thought about the initiative and whether it’s truly a coup for transparency in health. They agreed it’s moving Canada in the right direction, but by baby steps when other countries are making giant leaps.
That’s because of what this new website won’t include: the reporting of results from trials. “There are parts of this proposal that I like, and parts that I don’t,” wrote Dr.Michael Law (PhD) a pharmaceutical policy researcher at the University of British Columbia, in an email. “The part I like is that Health Canada is going to publish information on clinical trials that they authorize, which means the completeness of the data set is likely to be quite good. What I like less, however, is how limited the information is going to be.”
He noted that Health Canada is not pushing the people who run trials to put results of their studies on the database, or even specify an end date for their experiments. Without these requirements, “I’m not sure this will do much to counter the concerns about selective publication that likely skew our understanding on the true benefits and harms of prescription drugs.”
Dr. Karmela Krleza-Jeric, based in Montreal, is a global expert on transparency in clinical trials and one of the people who created the international standards for reporting on clinical trials at the World Health Organization. She pointed out that Health Canada’s new database falls short of those standards and felt the effort was “too little, too late.”
Her main concern was that it does nothing to address the fact that Canada—unlike its international counterparts—still does not require trial sponsors to register trials on international databases. This would consolidate knowledge and uphold the global standard, she explained. “The Health Canada database should include the registration number and link to a WHO-accepted registry,” she said, suggesting that could have been a quick fix to the issue. “Canada does not need the registry. We need a policy and tools to implement it.”
Others who study global pharmaceutical regulation also charged that Canada is a laggard when it comes to formalizing transparency measures. In comparison with the U.S., for example, “Canada lacks the kind of stringent rules on registration of clinical trials and results reporting, accompanied by serious penalties for non-compliance,” said Dr. Trudo Lemmens (PhD), a health law researcher at the University of Toronto. Also, unlike the U.S. FDA, Health Canada only provides summaries of its decisions about drugs instead of making transparent all the evidence on which those decisions rest.
So if Canada lags on transparency, the more interesting question is why. For example, why is it that Health Canada and dedicated senate committees have been studying how to overhaul the clinical trials process since 2005, but we’re only now addressing that gap in knowledge with this limited measure?
Some say part of the reason is that Health Canada doesn’t want to stifle innovation and deter pharmaceutical companies from running trials here. Jack Corman, the president of IRB Services, which conducts ethics reviews of clinical trials, pointed out that health regulators are in a tough position because more stringent regulation can be seen as anti-business and lead to “dysregulation“—or dysfunctional regulation.
As well, Corman said more regulation isn’t necessarily better, asking whether the costs of transparency will outweigh the benefits. For example, he asked how many independent researchers would actually search for the patient-level data on registries and have the wherewithal and resources to analyze them. “This all sounds fine and dandy,” he said, “but when you get into the real world, it just doesn’t compute.”
Another impediment: legislative barriers and a lack of political will. Dr. Brian O’Rourke, the president and CEO of the Canadian Agency for Drugs and Technologies in Health, which advises provincial and federal governments on which drugs and devices to cover on their formularies, said part of the reason Health Canada lags in transparency is because of our outdated Food and Drugs Act. “The act, which dates back to the 1950s, hasn’t been updated,” he explained. “The Ministry is trying to do that but I’m not sure it’s resonating well or it’s a high enough priority.” Dr. O’Rourke added in working with health regulators, he has seen up close what a tough job they have, and thinks pharmaceutical companies should take a leadership role in opening their data for the public good. “All of us have a shared responsibility to get information out.”
Striking the right balance between over-regulation and under-regulation, too littleopen data and too much is a tricky task. But Canada should learn from the leadership—and mistakes—of other nations and the global body of evidence that’s been accumulating. As Corman pointed out, “There’s no ideal (clinical trials) regimen, quick fix, no easy answers. One of my real concerns looking at what Canada is doing is that we seem to be emulating failed approaches from other jurisdictions in the hope we’re going make it better here.” That kind of wishful thinking is better left to things less important than our health.
source Maclean’s
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