International experts renew calls for registration of clinical trials

Main Category: Pharma Industry / Biotech Industry
Article Date: 23 Apr 2005 - 0:00 PDT

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A group of 80 international experts is calling for the public registration of all clinical trials. The Ottawa Statement, the result of an open meeting hosted by the Canadian Institutes of Health Research (CIHR) in October 2004, was published today in the British Medical Journal (BMJ).

"Publicly registering clinical trials will lead to the sharing of new knowledge that will accelerate the development of safer, more effective treatments," said Alan Bernstein, President of CIHR. "Consensus that public disclosure is a necessary ingredient of ethical clinical research is growing and CIHR's decision last summer to register the randomized controlled trials it funds is contributing to this momentum."

"Health Canada will continue to move toward greater transparency and awareness of information on clinical trials - I want Canadians to have access to the good, the bad and the ugly," said the Hon. Ujjal Dosanjh Minister of Health. "The World Health Organization has recently launched a process to develop a global approach to clinical trial registration and Health Canada and CIHR will be contributing to this process."

Sally Brown, Steering Committee Member of the Health Charities Council of Canada (HCCC) shared the support of national health charities and applauded the leadership of the Canadian research community to registration of clinical trials. "HCCC strongly supports the efforts of the Government of Canada to make the clinical trials process more transparent for the benefit of Canadians participating in trials and, indeed, for all Canadians," said Sally Brown.

The registration of clinical trials has been of long-time interest to the research community. Widespread media coverage last spring of reports linking suicide to the use of anti-depressants in children highlighted the need for early public access to evidence obtained through clinical trials.

The Ottawa Statement outlines three key principles for registration to help ensure clinicians, researchers, patients and the public have access to information about clinical trials. These principles are:

1 Registering all types of trials - Protocol information and results from all trials related to health or healthcare - regardless of topic, design, outcomes, or market status of interventions examined - should be registered and publicly available;

2 Timing of public release of protocol information - The public should have cost-free access to each trial's unique ID, minimum protocol items, and consent forms prior to participant enrolment. Registered amendments should be made publicly available as they occur;

3 Registering unpublished results - At a minimum, results for outcomes and analyses specified in the protocol (as approved by the main institutional review board/independent ethics committee), as well as any data on harms, should be registered regardless of whether or not they are published.

"The Ottawa Statement on clinical trial registration is already having an impact," says Dr. Karmela Krleza-Jeric, co-author of the Ottawa Statement and CIHR clinical research officer, referring to a group assembled by the World Health Organization that has used the Ottawa Statement to guide its development of global trial registration protocols, "In the coming year, we will continue to work together to define the most effective and practical ways to put these principles into action throughout the world."

In July 2004, CIHR began registering all randomized controlled trials it funds. In September, many of the world's major medical journals decided only to publish results of registered clinical trials.

About CIHR

The Canadian Institutes of Health Research (CIHR) is the Government of Canada's agency for health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system. Composed of 13 Institutes, CIHR provides leadership and support to almost 10,000 researchers and research teams in every province of Canada.

For additional information contact:

Janet Weichel McKenzie
Canadian Institutes of Health Research
613 941-4563 wk 613-447-4794 cell
jweichel@cihr-irsc.gc.ca

Adèle Blanchard
Office of Minister Dosanjh
(613) 957-0200

Health Canada

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