Do Clinical Trials In Canada Suffer From Poor Oversight?
By ED SILVERMAN
Are clinical trials conducted in Canada suffering from poor regulatory oversight?
A report suggests that Health Canada has been lax and, as a result, risky work is sometimes performed by Canadian doctors who are running trials for drug makers.
After reviewing FDA inspection reports on Canadian trials, The Star writes that some doctors did not report all adverse events and reported that some patients responded more favorably to treatment than they actually did. Some physicians also failed to tell trial participants that one of the goals of a clinical trial is to test the safety of the drug they were being given. The story has some specific examples.
The paper relied on FDA documents after Health Canada balked at releasing its own inspection reports. Why? The regulator explained reports could only be released after consulting with third parties, notably the physicians and drug makers. There is another issue – The Star writes that Health Canada inspects only a “sliver” of the 4,000 or so trials that under way at a given time.
Consequently, the paper writes that much of the oversight responsibility rests with the drug makers sponsoring the trials, as well as research and ethics board. Meanwhile, the FDA documents indicated that problems with the way trials were conducted – such as reporting side effects – were found in more than 60% of the 192 study sites the agency inspected since 1981.
What else did The Star find? Health Canada only began a trial inspection program in 2002, and the data made available shows the regulator has not met its goal of inspecting 2% of trials each year. A 2011 auditor general report found that, when the agency does find a problem, it can take up to 1432 days to inform study investigators of the deficiencies.
Unlike the FDA, Health Canada inspection reports do not identify the drugs, the physicians running trials or the drug makers, because “confidential and/or proprietary information” is removed from summary reports. We should note, however, that the FDA often redacts certain information from inspection reports as well.
Moving on, during the past decade, Health Canada found at least 33 clinical trials with serious problems and not in compliance. The Star asked for details but was told the request would “require an exhaustive manual paper file review.” Meanwhile, the regulator refused to say how many clinical trials had been halted, if any.
A Health Canada spokesman sent us a note saying new powers in a proposed bill, called Vanessa’s Law, would give the Minister of Health authority to make more available clinical trial information “than ever before.” The law would also provide tools to respond to drug safety issues, such as carrying out mandatory product recalls or requiring additional testing.
In general, he wrote, the regulator is “committed to making more information about its regulatory activities publicly available” through what is being called an Openness and Transparency Framework. For instance, drug safety review summaries are now being published and summary reports of inspections of manufacturing facilities are starting to be posted. Annual reports summarizing inspection results, which contain statistics and examples of problems cited during inspections, are also being made available.
