Canada's Clinical Trial Infrastructure: A National Framework For Coordinating Clinical Trials

Author:Ms Christelle Gedeon and Joanie Lapalme
Profession:Fasken Martineau
 
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The Standing Senate Committee on Social Affairs, Science and Technology released a report in November (2012) entitled Canada's Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines, which paints a dreary picture of the health of the Canadian pharmaceutical R&D landscape. The report indicates that Canada is losing its ability to attract clinical trials by pharmaceutical innovators. This decline in clinical trial activity is expected to translate into lost opportunities for Canada in drug innovation. The report proposes a standardized approach to research ethics review and the reporting of data in an open and transparent process as a step stone to resolving the issue. These changes are expected to significantly impact the time required to launch clinical trials and help Canada reclaim a competitive edge.

The report is the first phase of a four-part study aiming at examining and reporting on prescription pharmaceuticals in Canada. Over the course of eleven (11) meetings, from March 28 to May 30, 2012, the Committee heard testimony from Health Canada, the Office of the Auditor General of Canada, representatives from the pharmaceutical and clinical trial industries, patient advocacy groups, medical, ethical and legal academics and representatives of research ethics boards. 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 primary objective of the report is to provide recommendations to the federal government that may position Canada more favourably on the global stage as a preferred jurisdiction for clinical trials. Among the first recommendations is the creation of a National Framework for Coordinating Clinical Trials. At the moment, clinical trials for the same pharmaceutical entity are performed in silos. Each site operates independently. Sites are limited to their patient population and are restricted to the ethics review within their own institution. The creation of a National Framework is expected to promote the importance of new clinical trials and the benefits of being a participant to the individual and to the community at large. Most importantly, it is intended as a point of...

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