Support for registration/numbering of trials

European registers
Confidential registration of trials already exists in France, Italy, Spain and the Netherlands; registration of ongoing RCTs has been discussed at national level in Denmark and Germany. National registers of RCTs are beginning to be established in several other European countries, as are international and/or disease-based registers, such as PsiTri (the European Psychiatry Trials Register, http://www.psitri.helsinki.fi/project/project.htm).

European Clinical Trials Directive: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. The Directive states that, “Information on the content, commencement and termination of a clinical trial should be available to the Member States where the trial takes place and all the other Member States should have access to the same information. A European database bringing together this information should therefore be set up, with due regard for the rules of confidentiality.”
http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/l_121/l_12120010501en00340044.pdf

European Science Foundation
The European Science Foundation Policy Statement on Controlled Clinical Trials (May 2001) "endorses calls for prospective registration of controlled trials, and recommends that its Member Organisations should:

• Require registration as a condition of releasing funds for supporting randomised trials.
• Contribute core data items from their registers of randomised controlled trials to the international metaRegister of Controlled Trials at: www.controlled-trials.com
• Support the development and use of an International Standard Randomised Controlled Trial Number (ISRCTN)."

The Association of the British Pharmaceutical Industry (ABPI)
The ABPI has recommended all member companies active in the UK register details of Phase III trials within 3 months of approval in a major market; thereafter Phase IV trials prospectively. The trial records will be freely accessible and will be shared with the mRCT.
http://www.abpi.org.uk/press/press_releases_00/001003.asp

Department of Health in England and Wales Research Governance Framework for Health and Social Care
The Research Governance Framework defines the broad principles of good research governance and aims to ensure that health and social care research is conducted to high scientific and ethical standards. The document states that it is the responsibility of Research Funders to ensure that appropriate arrangements are in place for the registration of trials, and for Principal Investigators to ensure that controlled trials are registered.
http://www.doh.gov.uk/research/rd3/nhsrandd/researchgovernance.htm

USA
US Food and Drug Administration (FDA): The FDA Modernization Act of 1997 mandates registration for trials on drugs for serious and life-threatening diseases and conditions; the National Library of Medicine (for the US National Institutes of Health) has established a register of these trials at:
http://www.ClinicalTrials.gov

Australia
In February 2001, the State Government in Australia announced that they were creating the country's first public register of clinical drug trials by ordering all public hospitals to include the information in annual reports.
http://old.smh.com.au/news/0102/15/pageone/pageone2.html

Other organisations that support registration/numbering of trials

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
Standards for reporting RCTs have been developed (and revised) in 2001 by the CONSORT Group, and adopted by many journals. Some items were not considered essential for inclusion in an RCT report, but were felt to be highly desirable. These "items include institutional ethical review board approval, sources of funding for the trial, and a trial registry number (as, for example, the International Standard Randomized Controlled Trial Number (ISRCTN) used to register the RCT at its inception").
http://www.biomedcentral.com/1471-2288/1/2/

Contributors to the metaRegister of Controlled Trials
http://controlled-trials.com/mRCT/mRCT_contributors.asp

The Lancet
In a recent article (McNamee D: Review of clinical protocols and The Lancet. Lancet 2001, 357:1819), The Lancet announced a collaboration with Current Controlled Trials. David McNamee wrote "that The Lancet will ask all investigators who send in a protocol to register the protocol for an ISRCTN if they have not done so already. We will also ask investigators of protocols that we have accepted to register for an ISRCTN."
http://pdf.thelancet.com/pdfdownload?uid=llan.357.9271.editorial_and_review.16529.1&x=x.pdf

Recent articles providing scientific and ethical reasons for prospective registration of controlled trials

Chalmers I: Current Controlled Trials: an opportunity to help improve the quality of clinical research. Curr Control Trials Cardiovasc Med 2000, 1:3-8.
http://cvm.controlled-trials.com/content/1/1/3/

Grynszpan D, Godlee F, Marley C, Greenwood A: How prospective registration can help research in palliative care. European Journal of Palliative Care, Abstracts of the 2nd Congress of the EAPC Research Network, Lyon, 2002, p 56.
http://www.eapcnet.org/lyon2002/lyonabstracts.html#171

Horton R, Smith R: Time to register randomised trials. Lancet 1999, 354:1138-1139.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10513702&dopt=Abstract

Horton R, Smith R: Time to register randomised trials. The case is now unanswerable. BMJ 1999, 319:865-866.
http://bmj.com/cgi/content/full/319/7214/865?view=full&pmid=10506022

Marley C, Greenwood A, Godlee F: International Standard Randomised Controlled Trial Number: what is it and how will it help systematic reviewers? BMC Meeting Abstracts: 9th International Cochrane Colloquium 2001, 1:pb093 (26 August 2001).
http://www.biomedcentral.com/abstracts/cochrane/1/pb093/

Marley C, Godlee F, Chalmers I: An international metaRegister and unique identification system for randomized trials. Control Clin Trials 2001, 22 (suppl 2S):33S.

Tonks A: Registering clinical trials. BMJ 1999, 319:1565-1568.
http://bmj.com/cgi/content/full/319/7224/1565?view=full&pmid=10591727

Sykes R: Being a modern pharmaceutical company: involves making information available on clinical trial programmes. BMJ 1998, 317:1172.
http://bmj.com/cgi/content/full/317/7167/1172?view=full&pmid=9794848

Vale CL, Stewart LA: The International Standard Randomised Controlled Trial Number (ISRCTN): what does it mean for reviewers? BMC Meeting Abstracts: 9th International Cochrane Colloquium 2001, 1:pb092 (26 August 2001).
http://www.biomedcentral.com/abstracts/cochrane/1/pb092/