Canadian Statement calls for clinical trials registration

The Ottawa Statement was published in the British Medical Journal (BMJ). It outlines three key principles for registration to help ensure clinicians, researchers, patients and the public have access to information about clinical trials.

The first principle is to register all types of trials, with protocol information and results from all trials related to health or healthcare registered and publicly available.

The second is the timing of public release of protocol information. The statement claims the public should have cost-free access to each trial’s unique ID, minimum protocol items, and consent forms prior to participant enrolment.

Finally, the statement is concerned about registering unpublished results. At a minimum, the statement says, results for outcomes and analyses specified in the protocol, as well as any data on harms, should be registered regardless of whether or not they are published.

“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 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 the Canadian Institutes of Health Research (CIHR) will be contributing to this process.”

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.

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.