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 contact between the pharmaceutical industry and the research community for sharing experiences with patient recruitment, treatment and clinical outcomes.
Second, the report recommends improving the lack of transparency and the need for increased public disclosure about ongoing clinical trials. This is particularly a concern for patient advocacy groups and health care professionals. The registration of clinical trial data on a publicly accessible database would help providers make informed decisions and would increase access to new medicines for patients seeking alternative options. It would also allow academics to perform a comprehensive analysis of trial data, producing more valuable risk-benefit profiles for new therapies. Foreign clinical trial data used to support submissions for drug approval in Canada should also be registered in order to better inform the strict risk-based approach employed by Health Canada in approving drugs for sale in the Canadian marketplace.
Third, the report calls for the standardization of the research ethics review process and the accreditation of research ethics boards. Originally, research ethics boards were created within academic institutions. Over time, many trials for new drugs have moved into the community and are led by community based physicians or contract research organizations. As such, ethical review of clinical trials varies among research centers. Most, if not all clinical trial sites establish their own research ethics review board and operate under their own guidelines. An accreditation process is proposed as a method of improving the lack of consistency among ethics boards. Accreditation would impose a uniform set of rules for the approval of clinical trials in Canada.
To complement the changes to the clinical trial regime, the report further called for changes to the drug regulatory regime. The recommended changes would require that clinical trial design reflect the population that can reasonably be expected to consume the drug once it is on the market. For example, where drugs are specifically designed for use in pregnancy, a population of pregnant patients should be included in the clinical design. Consequently, market approval should only be granted by Health Canada if clinical trial data is available about all relevant population sub-groups.
Finally, the issue of rare diseases and the need for specific policy measures aimed at encouraging drug development and improved drug access for patients with rare diseases (an Orphan Drug Policy), were also examined. The hope is that the recent creation of the Orphan Drug Framework will encourage research and development as well as facilitate authorization of new drugs. The hope is that the framework will promote Canada as a preferred site for conducting clinical trials for orphan drugs and facilitate the work of stakeholders to develop strategies for maximizing patient recruitment into such trials.
Canada's ability to attract life science investment from major pharmaceutical innovators has been critical in maintaining the infrastructure of the medical system and keeping Canada at the forefront of medical innovation. This report is an indication that Canada has set its eyes on regaining its competitive edge on the world stage as a destination for investment and innovation in medicine.
This report is the first phase of a four-part study on medical research and innovation; we will keep you informed of the next three phases which will discuss the post-approval monitoring of prescriptions pharmaceuticals, the off-label use of prescription pharmaceuticals, and the nature of the unintended consequences in the use of prescription pharmaceuticals.