The metaRegister of Controlled Trials and the International Standard Randomised Controlled Trial Number

An introduction

'The case for registering all clinical trials is now unanswerable' (BMJ/The Lancet, October 1999)

How will the metaRegister help?

• Assist in the planning of new trials
• Avoid unnecessary duplication of research
• Encourage collaboration
• Facilitate optimal use of research funds by funding agencies
• Facilitate patients' access to information and improve recruitment
• Improve opportunities for methodological research
• Reduce discrepancies between published results and original trial protocol
• Help to detect publication bias

Who will use the metaRegister?
The Current Controlled Trials (CCT) website (http://controlled-trials.com) was set up in October 1998 in response to growing demand for more openness about clinical trials. CCT's metaRegister of Controlled Trials (metaRegister) aims to promote the availability and exchange of information about randomised controlled trials in all areas of healthcare so that:

• Patients and clinicians can find out about ongoing trials to which they might contribute
• Researchers and funders can avoid duplicating research and wasting valuable resources
• People preparing systematic reviews of research can take account of possible publication bias

What do the experts say?
An extract from an article in the British Medical Journal and The Lancet by their editors Richard Smith and Richard Horton, October 1999:

"The case for registering all clinical trials – first advanced a decade ago – is now unanswerable. The public has the right to know what research is being funded. Researchers and research funders don't want to waste resources repeating trials already underway. And those conducting systematic reviews need to be able to identify all trials begun on a subject to avoid the problem of publication bias. Otherwise, clinicians may be deceived on what the evidence shows."

(Horton R, Smith R: Time to register randomised trials. BMJ 1999, 319: 865-866.)

What is the metaRegister?
The metaRegister provides access to major registers making it one of the largest controlled trials resources in the world. Although its primary aim is to include information about ongoing controlled trials, the metaRegister does include information about some completed trials. In order to make the metaRegister as comprehensive as possible we are calling upon:

• funding agencies, medical charities, drug and device manufacturers to require registration of their trials, and to share their trial registers with the metaRegister
• lead principal investigators and sponsors to register their own trials
• ethics committees and journal editors to advocate registration of trials before they are eligible for approval or publication

The metaRegister aims to improve information exchange and thereby reduce duplication and wastage, and minimise the problem of publication bias. All records in the metaRegister are in English.

Access to the metaRegister is free of charge
To find out more and to register for updates on the development of the metaRegister contact info@controlled-trials.com

How can we prevent confusion between different yet similar trials?
International Standard Randomised Controlled Trial Number
One of the most important tools required to improve the accessibility of trial data is a simple method of identifying trials throughout their lifecycle. The ISRCTN scheme was conceived to address the confusion experienced by the clinical trials community in which several trials may have the same title, one trial may be reported in several places under different titles, and many trials are never reported. The ISRCTN register assigns a unique number to each randomised controlled trial in order to track the trial unambiguously throughout its life cycle. Current Controlled Trials was guided in the early stages of this project by its own International Advisory Group and an informal working group that included representatives from the UK Cochrane Centre, the Medical Research Council, the UK Co-ordinating Committee for Cancer Research, industry and consumers.

Here's how you can help:

• Sponsors: apply for an ISRCTN for your trial(s). Contact us for further details at isrctn@controlled-trials.com
• Ethics committees and review boards: consider requiring ISRCTNs in application details
• Editors: strongly advocate ISRCTNs as a prerequisite for publication

Find out more about the ISRCTN scheme from the Current Controlled Trials website or contact isrctn@controlled-trials.com.

Current Controlled Trials has the benefit of an International Advisory Group. Click here to see a full list of members.

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