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NHS Trusts Clinical Trials Register - Key points
(10 February 03)
This document is a summary of the key points concerning the new NHS Trusts Clinical Trials Register.
What is the NHS Trusts Clinical Trials Register?
The NHS Trusts Clinical Trials Register is a new register of randomised controlled trials in England that end after 31st March 2003 and for which the research costs have been met by the NHS. The register is being supported under a 3 year contract let by the Department of Health.
What are we being asked to do?
You are being asked to provide slightly fuller information on a small number of projects that are routinely included in your submissions to the National Research Register (NRR) – please see below. The good news is that the additional information can be included within the fields that are already familiar to you.
What are the benefits to researchers?
The NHS Trusts Clinical Trials Register will be made available online within the Current Controlled Trials’ metaRegister of Controlled Trials - an international register of randomised controlled trials (see http://www.controlled-trials.com/mrct/). The benefits to researchers are that the results and reports accrued by locally run randomised clinical trials will be available to researchers worldwide and the work could be included in meta-analyses.
Why is the NHS Trusts Clinical Trials Register being created?
- To ensure that all randomised controlled trials carried out in England for which the research costs have been met by the NHS are registered, as required by the Research Governance Framework.
- To assign International Standard Randomised Controlled Trial Numbers (ISRCTN) to these trials. The ISRCTN is a simple numeric system for the unique identification of clinical trials worldwide. It simplifies the identification of trials and provides a unique number that can be used to track all publications and reports resulting from each trial (see http://controlled-trials.com/isrctn/isrctn_faqs.asp for more information).
When do we have to do this?
We should like you to include the additional details listed below for your March 2003 return to the NRR.
How do you wish us to do this?
All you need to do is to ensure, as an NRR Data Provider, that the records you send to the NRR are complete and up-to-date. All relevant records will then be extracted from the NRR and added to the new register.
Do we need to change anything in the records we send to the NRR?
No, but you do need to make sure records for randomised controlled trials that end after 31st March 2003 are complete and up-to-date. Specifically:
- The methodology field must state that the record is a randomised controlled trial and should state what comparisons are being made. A supplement to the NRR guidance document concerning the methodology field has been issued to help (see http://www.update-software.com/national/SupplementToGuidance.pdf).
- The funding organisation fields must be filled in if a project is receiving funding from external organisations.
- Multi-centre trials must be coded as such and the record must show whether or not you are the lead centre in a multi-centre trial.
Which of the trials submitted by us will be included in this new register?
Only the randomised controlled clinical trials. You need to ensure that the comparison groups in the trial have been generated at random using a computer, or random number tables, or some other technique guaranteed to abolish selection bias. This does not apply to controlled clinical trials that have not been randomised, which are not being included in the register.
If I am not sure whether a trial should be included, whom should I contact?
Hélène Faure
Editorial Project Manager
Current Controlled Trials Ltd
Floor 6, 236 Gray's Inn Road, London WC1X 8HL, UK
Tel: +44 (0) 20 3192 2000
Direct line: +44 (0)20 7631 9935
Fax: +44 (0) 20 3192 2011
Email: helene.faure@cursci.co.uk
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