Current Controlled Trials' strategy for supporting the continued development of the mRCT and ISRCTN scheme, making freely and publicly available information on ongoing randomised controlled trials

INTRODUCTION
Current Controlled Trials Ltd (CCT) is committed to providing free and open access to information about ongoing randomised controlled trials, and this remains the guiding principle behind the company's activities.

CCT published a Strategic Review in September 2001. In this, CCT undertook to submit an application for a three-year grant from the European Union (EU), that would contribute substantially to CCT's core funding. The application was submitted under the Fifth Framework Programme Quality of Life and Management of Living Resources Programme in October 2001, and resubmitted - taking account of feedback from the evaluation panel - in February 2002. This application was a carefully developed response to published but unimplemented EU calls over the past decade for clinical trial registration; both submissions, however, were rejected.

This decision has inevitably led CCT to take stock of its position. CCT cannot continue to sustain the overall costs of running the mRCT/ISRCTN, but is committed to ensuring that access to the mRCT/ISRCTN information remains free.

BACKGROUND

• Current Controlled Trials (CCT) took part in the meeting convened at the UK Cochrane Centre in July 1998 to take forward prospective registration of controlled trials, and offered to develop and make freely available a metaRegister of Controlled Trials.
• A pilot register was launched by CCT within three months. It now contains 24 registers (>14,000 records) from four continents.
• The mRCT provides a valuable service: there are more than 18,000 registrants on the CCT website.
• Working closely with the Medical Research Council, the UK Co-ordinating Committee on Cancer Research and others, CCT has also led the development of the International Standard Randomised Controlled Trial Number (ISRCTN).
• During the pilot phase, >350 ISRCTNs were assigned in the UK alone. Click here to view the ISRCTN Register.
• A commitment was made initially that there would be no charge to deposit information in the mRCT (unless significant editing was required).
• CCT continues to explore other sources of income, including building and maintaining registers for outside organisations.
• The European Science Foundation (ESF) 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 mRCT, and support and use the ISRCTN. The ESF hosted a symposium on 19 November 2002 in Frankfurt to discuss progress on prospective registration of clinical trials in Europe. The outcome of this meeting is that the ESF plan to issue a communiqué in the New Year to their member organisations and to ministries of health within their member countries urging them to implement the ESF 2001 policy briefing.

Following consultation with members of the mRCT/ISRCTN international advisory group and the ISRCTN working group, CCT has decided to look to clinical trial sponsors and other register-holders to support the effort to provide information on ongoing trials free to the user. Plans are as follows:

mRCT - charge for participation in the mRCT
From October 2002, organisations wishing to include their trial register in the mRCT, and so bring it to a wider audience, will be asked to contribute to the costs of processing, indexing, and displaying the information, and ensuring that it is continuously available via the CCT website, so that is freely available to users.

ISRCTN - administrative charge for ISRCTN assignment
From January 2003, an administrative charge will be made for each ISRCTN assigned.

For further details, please contact info@controlled-trials.com.

3 January 2003