December 14, 2004 OTTAWA - Health Minister Ujjal Dosanjh, reaffirming his commitment to openness and transparency, today released Health Canada’s 2003-2004 Summary Report of inspections of clinical trials. The objectives of the report are to ensure the well-being of Canadians involved in clinical trials, while also educating scientific and research ethics communities and the public, on their roles and responsibilities in the conduct of clinical trials in Canada. “As an advocate for public health, I strongly favour public disclosure of all clinical trials, including the results of findings made during inspections of clinical trials in Canada,” said Minister Dosanjh. “The inspections allow us to verify that trials are conducted in compliance with regulatory requirements of the Food and Drugs Act and Regulations.” The inspection report highlights the observations made at five leading Canadian pediatric research institutions in 2003-2004. These inspections included 45 clinical trials, an increase from 18 in 2002-2003. All deviations from the regulatory requirements, noted during the inspections, were rectified and none warranted a suspension or cancellation of a clinical trial. “I am very pleased with the cooperation displayed by researchers, research ethics boards, institutions and sponsors who took all the necessary steps to comply with their regulatory obligations,” added the Minister. “This collaborative approach allows us to maintain the highest level of scientific and ethical standards for the conduct of clinical trials in Canada, which results in more effective therapies for Canadians.” Health Canada is the regulatory authority responsible for the review and authorization of clinical trials involving human subjects, including compliance activities. Inspections of clinical trials are conducted on a selected number of clinical trials, and focus on protection of subjects enrolled in clinical trials. The Health Products and Food Branch Inspectorate of Health Canada delivers compliance and enforcement activities, including inspections, compliance verifications and investigations. Clinical trial inspections in 2004-2005 are focussing on other areas of research and ethics. The full 2003-2004 Summary Report of the inspections of clinical trials can be found at http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate/gcp_inspection_sum_rep_2003-2004_tc_e.html. -30- Media Inquiries: Jirina Vlk Health Canada (613) 957-2988 Adèle Blanchard Office of the Minister of Health (613) 957-0200 Public Inquiries: (613) 957-2991
