Canadian Senate committee finds faults in current clinical trials system

The absence of a standardized approach to research ethics review significantly impacts the time required to start up clinical trials in Canada and restricts the reporting of data in an open and transparent process. First and foremost, in changing the way we do clinical trials, must be the safety of Canadians and the effectiveness of the drugs they rely on, says a report from the Canadian Standing Senate Committee on Social Affairs, Science and Technology.

Titled Canada's Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines, the report is the first phase in a study to examine and report on prescription pharmaceuticals in Canada. Over the course of 11 meetings, from March 28 to May 30, 2012, the committee heard testimony from Health Canada, Office of the Auditor General of Canada officials, representatives from the pharmaceutical and clinical trial industries, patient advocacy groups, medical, ethical and legal academics and representatives of research ethics boards.

“While the quality of clinical trials has always been high in Canada, the drug industry suggested that this is no longer sufficient to give Canada a competitive advantage. Other developed countries have caught up to Canada in this regard as they have realized the benefits of increased clinical trial activity in their jurisdictions,” said Kelvin Ogilvie, chairman of the committee, adding: “High cost and slow implementation of clinical trials were described as aspects where Canada falls short and are reasons for the declining clinical trial activity in this country. This was attributed to the lack of a clinical trial infrastructure in Canada.”