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Current Controlled Trials' numbering scheme is adopted by CHIR

July 23, 2004

Dr. Alan Bernstein, President of the Canadian Institutes of Health Research (CIHR), announced today a new randomized controlled trial policy that will require all CIHR funded clinical trials to register with an International Standard Randomised Controlled Trial Number (ISRCTN). The goal of the policy is to help ensure clinicians, researchers, patients and the public have access to information about CIHR clinical trials.

"The new CIHR policy will help to support the drive for greater openness of information about randomised controlled trials among its various stakeholders-including patients, researchers, funding agencies, and policy makers," said Dr. Bernstein. "It will also ensure the health research community is kept up-to-date with the latest clinical trial research being conducted around the world."

The ISRCTN is a simple numeric system for the identification of randomised controlled trials (RCTs) worldwide. It was developed by the UK-based company Current Controlled Trials, Ltd., which is part of the Current Science Group of biomedical publishing companies. Once assigned an ISRCTN, basic information about each randomised controlled trial (RCT) is posted on the website of the ISRCTN Register (http://www.controlled-trials.com)

The goal of the ISRCTN system is to be able to differentiate between trials, simplify their identification and enable the tracking of any trial through its life cycle, including all results.

Randomised controlled trials are studies in which people are allocated at random to receive one of several health interventions. RCTs are used to compare two or more interventions. They are considered to be the gold standard of clinical research because they provide the most reliable evidence.

However, randomized trials are difficult to identify, especially those that are ongoing and unpublished. As a result, potentially important information from unpublished trials are often not taken into account when the scientific community summarizes all of the available RCT evidence to guide clinical practice and health policy.

In the context of moving to a new level of accountability regarding the research that it funds, CIHR performed a thorough analysis of the current trends in clinical research, including trials that the agency has been funding. Consequently, in addition to the continuously improving peer review process, CIHR decided to increase the value and practical application of the trials that it funds through the assignment of the ISRCTN to all of them.

"CIHR is in good company," says Anne Greenwood, Managing Director of Current Controlled Trials, Ltd. "Other leading funding agencies, such as the UK's Medical Research Council, as well as the World Health Organization, are assigning ISRCTNs to their respective randomised controlled trials to ensure that basic information about their trials is made available to a wider audience."

Aside from informing clinicians, researchers, patients and the public about ongoing trials, the assigning of the ISRCTN to all CIHR randomised controlled trials is expected to:

o encourage collaboration between researchers and community
o reduce publication bias
o differentiate between trials with the same title
o identify trials that might use several different titles
o reduce duplication of research efforts, and
o increase the international visibility of Canadian research

BioMed Central Limited