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Director of St. Michael’s Research Ethics Office testifies at Senate committee looking into clinical trials

Toronto, November 12, 2012

By Leslie Shepherd

Sharon Freitag
Sharon Freitag

A Senate committee has found 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.

The Standing Senate Committee on Social Affairs, Science and Technology, issued a report on Canada’s clinical trial infrastructure on Nov. 1, after hearing from expert witnesses, including Sharon Freitag of St. Michael’s Hospital.

Freitag, director of the hospital’s Research Ethics Office, appeared before the committee in May in her role as past president of the Canadian Association of Research Ethics Boards. CAREB is a national organization dedicated to promoting the protection of humans who participate in research. It has more than 300 members representing more than 200 research ethics boards across Canada.

Freitag told the committee that her organization has long recognized the need for changes in how clinical trials are initiated, reviewed and administered.

“Members of our association continue to express frustration with the ever-increasing workload due to the rapidly changing regulations and added legal and regulatory complexity in ethics review,” she said.

“Unfortunately, much of the regulatory burden has no bearing on patient or participant safety and, conversely, detracts from the primary purpose of the REB — to protect humans in research.”

Freitag said there are numerous obstacles to promoting streamlined ethics review nationally:

  • The lack of a Canadian accreditation system.
  • Interprovincial difference in privacy legislation.
  • Differences between research ethics policies and guidelines and the regulations of Health Canada or the U.S. Food and Drug Administration.
  • The lack of a national body to oversee and champion all aspects of human research protection.
  • A clinical trials registration system that is error-prone and relies on the researcher's buy-in to yet another administrative process, again with little to no impact on participant safety.

The Senate report, Canada's Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines, said the first consideration in changing the way we do clinical trials must be the safety of Canadians and the effectiveness of the drugs upon which they rely.

The report is the first phase in a study to examine and report on prescription pharmaceuticals in Canada.

Senator Kelvin K. Ogilvie, the committee chair, said that while the quality of clinical trials in Canada has always been high, the pharmaceutical industry suggested this was 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,” he said. “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.”

Senator Art Eggleton, the deputy chair, said the committee was concerned that the reporting of data from clinical trials was not as open and transparent as it should be.

“Despite assurances from Health Canada and CIHR officials, information on authorized clinical trials is not fully accessible by industry and the public,” he said. “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.”

The report makes 12 recommendations altogether.