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A shocking study found that only three per cent of Canadian human research trials testing new drug treatments or therapies meet all three international criteria that ensure fair and timely sharing of results for all to learn from.
Its authors say the look at whether these trials are properly registered, with results reported and formally published, serves as a clear warning that researchers may be wasting millions of dollars of funding, along with patients’ time and effort.
"Our data shows that there's basically no public record of many trial results... I think it's (scary) really," said Kelly Cobey, a co-author of the study, associate professor at the University of Ottawa and researcher at the university's Heart Institute.
The study, published in the journal Facets, reviewed some 6,720 clinical trials conducted in Canada between 2009 and 2019, all of which were listed on a public database. Some were conducted in Canada alone, while others had international collaborators.
An estimated 612,000 Canadian patients were involved, testing out treatments for conditions like diabetes, cancer, asthma, and multiple sclerosis, among others, along with the safety and effectiveness of new medical devices.
The question posed by the research team was to determine how many followed the World Health Organization guidelines from 2015, which specify that: clinical trials must be registered before they begin to ensure they follow a pre-planned design; that key findings are made publicly available within a year of the study’s completion; and that the results are published in a journal at most two years after completion, "regardless of the outcome."
Of the Canadian trials studied, however:
"Betrayed" is the word used by Geoff Eaton, a former cancer patient in St. John’s, N.L., when he heard about the results from CTV News.
At age 22, he was diagnosed with acute myeloid leukemia (AML) and then participated in a clinical trial.
Now 47 and the executive director of Young Adult Cancer Canada, Eaton says patients who agree to join a clinical trial, enduring all the invasive testing, do so with the specific goal of helping others.
“They feel like they're contributing to the betterment of care for the future of cancer patients, and clearly what this new study is showing is that almost all of that effort is disregarded or negated," said Eaton.
The study was led by Mohsen Alayche, a fourth-year medical student in Ottawa, who says he was “disappointed” to see so much wasted research, and that he worries all the unpublished data ultimately endangers patients.
"Let's assume there was a bad drug with adverse effects. If the results were never reported, then other researchers may reuse that same drug and affect more people over and over again,” said Alayche.
He said he also found that 42 per cent of Canadian studies that had international collaborators registered, reported and published results, while only 3 per cent of “Canadian only” trials met all three requirements. A link to the raw data and the institutions where the studies were conducted is provided in Alayche's paper.
Much of the research that is conducted in Canada is funded by drug companies and medical device firms, with an estimated budget of $2.1 billion in 2016.
The remainder of trials initiated in Canada are funded by health charities, universities, provincial health research agencies, and by taxpayers through the Canadian Institutes of Health Research. Last year the CIHR had a budget of $1.2 billion, supporting some 15,000 researchers across the country.
The bottom line, says Cobey, is “there’s a lot of waste, and as a research community we’re not helping anyone if we just keep the data to ourselves.”
Studies from around the world have found similar problems with vast numbers of unreported clinical trials. German scientists, for example, found that between 2009 and 2013, the results of only 39 per cent of clinical trials were published within two years of their completion, a rate similar to Canada’s.
A study earlier this year also found that 29 international studies on patients with multiple sclerosis registered on ClinicalTrials.gov were also never published.
Researchers also noted that MS studies with a "favourable" outcome regarding treatment were more likely to be published than those with negative findings.
"It's clearly unethical. And it's also scientifically irresponsible," said Till Bruckner, the founder of TranspariMED, a group trying to make all scientific data public and transparent. While he says some researchers may be deliberately hiding findings, he suspects that for the large majority, it's the result of forgetfulness combined with lax enforcement.
"In many cases, researchers decided that their clinical trial results weren't that exciting or that interesting, so they just decided to move on to the next trial," said Bruckner from his office in London.
"The problem that that creates is that other researchers then can't see that the trials have already been run and they might repeat it again and again and again," he said.
Bruckner points to the case of Tamiflu, which became a blockbuster antiviral medication thought to prevent severe cases of the flu. More than US$18 billion was spent on the drug worldwide, until researchers discovered data from eight clinical trials was missing and that agencies that recommended the drug’s use had never seen the full picture.
But it's a problem with a solution, Bruckner says. If governments can track cars with licence plates and drivers with licences, why can't "the government do that for thousands of clinical trials?" he asked.
Officials with the CIHR say the federal agency is doing its part.
In January 2022, it published a policy guide that requires all clinical trials funded by the institutes going forward to be registered before the first participants begin. It also requires results be disclosed publicly within a mandated time frame.
In an email to CTV News, CIHR officials said that in early 2023, the agency received data from “almost all of the 154 clinical trials funded by CIHR in 2022.
But Cobey says the reporting is voluntary, and so this system is not completely effective.
“As the funder, they have the onus to monitor trial registration and reporting using methods that will capture all of the studies they support,” said Cobey.
The federal government also recommends that researchers promptly update the study results, but critics say what’s missing are penalties, such as those being introduced by other countries.
Regulators in seven European Union countries can impose fines of up to 250,000 EUR on clinical trial sponsors that fail to make results public to studies launched after January 2022.
The U.S. also threatens fines of US$13,000 a day until clinical trial results are published.
The threat alone seems to work, says Bruckner. “In over 90 per cent of cases, the (study) results were up in a few weeks," he said, adding the U.S. Food and Drug Administration has yet to impose an actual fine.
Regulators in six countries – Austria, Belgium, Denmark, Finland, Germany and the Netherlands – go a step further, demanding trial sponsors dig out results of past drug trials and make them public.
Cobey says efforts need to be made in Canada to make funding agencies and scientists aware of the need to publish and to introduce education training.
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