Current Controlled Trials Strategic Review - 2001

When Current Controlled Trials (CCT) was established in 1998, its broad aim was to improve access to information about randomised controlled trials (RCTs). The metaRegister of Controlled Trials was set up within CCT to be an open access, fully searchable database of information from registers of planned and ongoing RCTs. CCT made an initial commitment to support the development and maintenance of the project for 3 years, after which time CCT would review its strategy in the light of developments. This strategic review has now taken place. The process, conclusions, and subsequent progress are summarised below.

Consultation process
In January 2001, CCT convened a meeting of a group of its advisors to formulate a strategy for CCT in relation to:

a)	the international registration and unique identification of randomised controlled trials, as the centrepiece for
b)	an application to the European Union for funding to underpin this work, through a multinational partnership coordinated by CCT; and
c)	the wider aims and objectives of CCT.

The delegates at the meeting were:
Gerd Antes (German Cochrane Centre)
Edvard Beem (Netherlands Council for Medical and Health Research)
Steve Berkowitz (US Veterans Affairs Cooperative Studies Program)
Maurizio Bonati (Mario Negri Institute, Italy)
Iain Chalmers (UK Cochrane Centre; Chair, metaRegister of Controlled Trials & ISRCTN International Advisory Group)
Rory Collins (Clinical Trial Service Unit, University of Oxford, UK)
Brian Davis (Medicines Control Agency, UK)
Marisa De Rosa (Centro di Calcolo Interuniversitario, Italy)
Philip Durrant (Current Controlled Trials, UK)
Bec Hanley (Consumers in NHS Research Support Group, UK)
Fiona Godlee (Current Controlled Trials, UK)
Anne Greenwood (Current Controlled Trials, UK)
William Harlan (US National Institutes of Health)
Jetty Hoeksema (Netherlands Council for Medical and Health Research)
Harry Keen (Emeritus professor of diabetes)
Richard Lilford (UK NHS Executive)
Claire Marley (Current Controlled Trials, UK)
Jill McEachern (UK Medical Research Council)
Joe McNamara (UK Medical Research Council)
Mark Starr (Update Software)
Ian Tarr (Current Drugs, UK)
Hazel Thornton (Independent advocate for quality in research and health care)
Vitek Tracz (Current Science Group)
Gerald Urrutia (Iberoamerican Cochrane Centre)
Norbert Victor (University of Heidelberg)
Elizabeth Wager (Glaxo SmithKline Research and Development)

The meeting explored ways of broadening the coverage of the metaRegister, implementation of the unique numbering scheme (International Standard RCT Number, ISRCTN), and long term funding.

Subsequent progress
Building on the discussions at the strategy meeting, CCT has undertaken the following:

1. An application for funding from the European Union
In partnership with key groupings within Europe, CCT is preparing an application for 3 years’ funding from the European Union. The partners include:

• CCT (coordinator)
• Centro Neurociencias de Lisboa, University of Lisbon
• Centro Cochrane Iberoamericano, Hospital de la Santa Creu i Sant Pau
• Consortium of Italian Universities (CINECA)
• Dutch Cochrane Centre
• German Cochrane Centre, University of Freiburg
• European Science Foundation
• UK Medical Research Council Clinical Trials Unit
• UK Consumers in National Health Service Research Support Unit

The objectives of the application are to work with European partners:

1. To create a climate in which approaches to organisations and individuals regarding the metaRegister and ISRCTN are more likely to meet with success.
2. To increase the number of organisations in Europe building new, or enhancing existing, online, study based registers of ongoing RCTs, whose data can be contributed to the metaRegister.
3. To increase the number of organisations and lead principal investigators in Europe participating in the ISRCTN scheme, and the appropriate use of the ISRCTN.
4. To improve the intelligibility to a lay audience of information in the metaRegister, and to help promote a better understanding of clinical trials among patients and the public, with particular reference to the metaRegister and ISRCTN.

2. Activities outside Europe
CCT continues its efforts to encourage register holders from outside Europe to share their registers with the metaRegister.

3. Site redesign
The redesigned site was launched in August 2001.

4. Improved data and functionality
Work is ongoing towards the publication of some standard formats for the representation of trial information. Further effort has been dedicated to maintaining the integrity of the material we hold. We hope to build upon these foundations to provide increasingly extensive facilities for the interrogation of CCT data.

5. Clarification of the relation between the metaRegister and the ISRCTN scheme
Rather than using the metaRegister as the base for the ISRCTN scheme, we now plan to create a separate ISRCTN database. This will also be open access, but will have three important features that distinguish it from the metaRegister:

1. To minimise the risk of duplication, only the sponsors of RCTs will be able to apply for numbers.
2. To remove the need to update ISRCTN records, the data requested will not include information about the status of the trial.
3. The ISRCTN database will cover all trials, whether planned, ongoing, or completed.

6. Work with other key groups to promote prospective registration and unique identification of trials
Important recent developments include:

a)	The Department of Health in England and Wales has included within its Research Governance Framework for Health and Social Care (March 2001) a responsibility, both for sponsor and principal investigator, to ensure that trials are registered.
b)	The European Science Foundation Policy Statement on Controlled Clinical Trials (May 2001) recommends that member organisations make trial registration a condition of funding, contribute core data items to the metaRegister, and support and use the ISRCTN.
c)	The CONSORT statement for improving reporting of the results of RCTs, which has been adopted by many medical journals, now includes encouragement to trialists to apply for an ISRCTN (see Consort Revised Recommendations).

7. Plans to develop other products and services
In parallel with developments on the metaRegister and ISRCTN scheme, CCT continues to explore opportunities to develop subscription products relating to trial registration and to follow up requests from third parties to help them with setting up, maintaining and hosting their own registers.