The Standing Senate Committee on Social Affairs,
Science and Technology Tables its Report on Clinical Trials

Ottawa (November 1, 2012) – 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 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 28 March to 30 May 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 the Honourable Kelvin K. Ogilvie, chair of the committee. “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.”

“The committee is concerned that the reporting of data from these clinical trials is not open and transparent as it should be”, said the Honourable Art Eggleton, the committee’s deputy chair. “Despite assurances from Health Canada and CIHR officials, information on authorized clinical trials is not fully accessible by industry and the public. This can only be achieved through mandatory registration. We ask the Minister of Health to make the necessary changes to the Food and Drugs Act to facilitate the disclosure of information.”

Witnesses told the committee that mandatory registration should be linked with the need to establish substantial penalties for drug companies contravening the clinical trial regulations.

The report makes 12 recommendations that address issues such as: enhanced leadership of the federal government; transparency of the clinical trial process; standards and accreditation of research ethics review; barriers to patient recruitment; inclusion of vulnerable sub-groups of the population; drugs for rare diseases; and, the need to assess patent protection and tax incentives.

“The time for Canada to act is now. Implementing the recommendations contained in this report will result in an improved clinical trial infrastructure, an increase in Canada's global competitiveness in the clinical trial sector and ultimately, improved access to innovative medicine for Canadians,” added Senator Ogilvie.