The lack of a properly coordinated infrastructure for clinical trials in Canada, and in particular of a standardised approach to ethics reviews, not only lengthens start-up times and pushes up costs for clinical research but is limiting transparency and blunting Canada’s international competitiveness in the field, a Senate committee has concluded.
“The time for Canada to act is now,” said Kelvin Ogilvie, chair of the Standing Senate Committee on Social Affairs, Science and Technology.
The committee’s report made 12 recommendations for change, spanning issues such as federal-government leadership in facilitating a comprehensive clinical-trials infrastructure in Canada; the transparency of the clinical-trial process; standards of research-ethics review; barriers to patient recruitment; drugs for rare diseases; and the role of patent protection and tax incentives as stimuli to drug development.
The new report, Canada's Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines, is the first phase of a wider project looking at prescription medicines in Canada, in accordance with an Order of Reference adopted by the Senate in November 2011.
The four components of this review, each to be studied separately, are: the approval process for prescription drugs, with a particular focus on clinical trials; the post-approval monitoring of prescription medicines; off-label use of these products; and unintended consequences in the use of prescription pharmaceuticals.
For the current report, the Senate committee heard testimony from a range of stakeholders, including representatives of Health Canada, the Office of the Auditor General of Canada, the pharmaceutical and clinical-trial industries, patient-advocacy groups, medical, ethical and legal academics, and research-ethics boards, over the course of 11 meetings between 28 March and 30 May 2012.
High cost, slow implementation
“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,” Ogilvie commented, noting that other developed countries had “caught up” after realising the local benefits of increased clinical trial activity.
“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,” Ogilvie added. “This was attributed to the lack of a clinical trial infrastructure in Canada.”
Senator Art Egglegton, deputy chair of the committee, highlighted concerns that data reporting from clinical trials in Canada is “not open and transparent as it should be”.
Despite assurances from Health Canada and the Canadian Institutes of Health Research, “information on authorised clinical trials is not fully accessible by industry and the public”, Eggleton noted. “This can only be achieved through mandatory registration.”
Among the report’s specific recommendations are:
• The federal government should set up a National Coordinating Office for Clinical Trials to provide leadership in the field; promote the importance of clinical trials and the benefits of being a participant; help to establish Canada as a preferred site for clinical research; and act as a point of contact between industry and research networks.
• The Ministry of Health should move immediately to require registration of clinical trials “to the greatest degree permitted under its existing legislative and regulatory authorities”.
• Manufacturers should be obliged register a comprehensive set of data for clinical trial Phases II and III, on a website recognised by the World Health Organization, before recruiting any participants – including, but not limited to, all results, adverse reactions, withdrawal of participants and trials ended prematurely.
• The Minister of Health should direct Health Canada immediately to develop an accreditation programme for Research Ethics Boards, starting with discussions on a national standard that could be applied to ethics reviews of all clinical trials for unapproved drugs in Canada.
• The new National Coordinating Office for Clinical Trials should encourage the creation of research networks and provide guidance to these networks on centralising research-ethics reviews and creating databases of patients willing to be considered for trials.
• Clinical trials must be designed to reflect “the same population that can reasonably be expected to consume the drug once approved for sale in Canada”.
• The federal government should create an expert advisory committee for “a thorough study of the intellectual property and tax incentive issues raised by stakeholders” during the review of clinical trials, exploring options and recommending changes “that will help to improve Canada’s global competitiveness in drug development”.