OTTAWA - Health Minister Ujjal Dosanjh today announced the launch of the first phase of consultations on the registration and disclosure of clinical trial information. The consultations are part of a national and international trend towards more transparency and information-sharing in the area of clinical trials. "I am very pleased that we are now starting the process that will lead to a Canadian approach to this important issue," said Minister Dosanjh. "Health Canada is committed to improving access to information about clinical trials so that Canadians can make informed decisions about their health. We are moving in this direction while taking into account some legitimate exceptions relating to personal privacy and business confidentiality." This preliminary consultation focuses on potential users of clinical trial information, including academics, community and consumer groups, industry, ethicists, patient organizations, health professionals, and medical journal editors. The consultations have two components, a questionnaire to gather information, followed by workshops. A Web-based questionnaire will be launched (the week of June 13, 2005) to help identify the need for, and requirements of, registration and disclosure of clinical trial information, including the types of clinical trials that should be registered, the timing of registration, the scope of information that should be included in a registry, roles and responsibilities, and the disclosure of clinical trial results. Workshops will be held in Ottawa June 15, 2005, in Halifax June 21, and in Vancouver June 23, to provide an opportunity for open discussion among stakeholders on the approach, opportunities and challenges of registration and disclosure of clinical trial information. The feedback gleaned from these consultations will be made public and will be used to help Health Canada develop options for facilitating the registration and disclosure of clinical trial information in Canada. Further consultations will take place in the late fall to obtain feedback on the options. "We are committed to working with international partners, industry and other stakeholders to obtain greater disclosure of clinical trial information," said Minister Dosanjh. "Consumers, health care providers and researchers all have a direct and compelling interest in obtaining as much information as possible." Clinical trials are studies that provide scientific evidence of a drug's quality, safety and efficacy in humans. They consider such questions as whether a drug is safe, what dosages are most effective and what side effects a drug may cause. The results of the questionnaire will be posted on Health Canada's website. Members of the public, media or other stakeholders who would like to have a copy of the questionnaire can contact: Tannis Topolnisky, Regional Public Involvement Officer at (780) 495-7437. -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
