Background: There now appears to be general support for the public registration of clinical trials. This support has been stimulated in part by the action of the International Committee of Medical Journal Editors (ICMJE) stating that, as of July 1 2005, only registered trials will be eligible for journal publication and, by the WHO International Clinical Trials Registry Platform (ICTRP) initiative to develop a Register Network and a Search Portal. The editors of the major kidney journals embraced these initiatives by calling for the public registration of trials before consideration for publication1.
Objectives: To develop a publicly accessible and searchable Prospective Trials Register for the nephrology community that complied with the WHO Clinical Trial Registration Data Set and followed the guidelines suggested by the ICMJE for trial registration. To work with the Australian Clinical Trials Registry (ACTR) as a collaborating register to enable the exchange of information so that trials registered with the Cochrane Renal Group Registry will be accessible via the WHO International Clinical Trials Registry Platform Search Portal.
Methods: In 2005 the Cochrane Renal Group (CRG) set up a web-based Prospective Trial Register accessible at http://www.cochrane-renal.org/trialsubmissionform.php . It is publicly accessible and searchable. The data requested complies with the 20 fields described in the WHO Trial Registration Data Set developed as part of the WHO ICTRP initiative. The registration process requires data about a trial to be submitted under the following headings: o Study title which includes an acronym or a web site for further information o Lead Investigator [position and contact details] o Study contact or Study coordinator [position and contact details] o Sources of funding o Study design [study design, group assignment, blinding, start and completion dates both proposed and actual, whether the study is multi-centre and multi-national] o Study description [research question in plain English, status of study, health care condition, interventions, participants, recruitment, inclusion & exclusion criteria, primary and secondary outcomes] o References [reports generated by study]. Once the data about a trial has been submitted, it is checked to ensure that the data is complete. If so, a registration number, e.g. CRG060400011, is then emailed to the registrants. Email follow-up is initiated if the data set submitted is incomplete and the registration is considered pending until all data is received.
Results: Since June 2005, 115 trials from 22 countries have been registered. These trials span various aspects of nephrology such as peritoneal dialysis, diabetic nephropathy, transplantation, nephrotic syndrome and contrast nephropathy. 70% are randomised trials; 28% are government funded while 26% are industry funded. The submission of incomplete data most frequently involves the lack of secondary & primary outcomes (in particular the lack of pre-specified timepoints for all outcomes) and information regarding the funding and sponsorship of a trial.
Conclusions: The number of trials registered has increased steadily over the last two years. The CRG registry has been endorsed by the editors of the major kidney journals1 and the CRG registration number has been cited in at least 5 publications to date. Collaboration with the ACTR is continuing. The CRG register is currently applying to join the WHO Register Network and the WHO Registry Platform Secretariat are in the process of ascertaining whether or not the register meets the requirements necessary to be a collaborating or partner register.

1. Couser W, Drueke T, Halloran P, Kasiske B, Klahr S, Morris P. Special announcement: a uniform clinical trial registration policy for journals of kidney diseases, dialysis and transplantation. American Journal of Kidney Diseases 2005;45(4):625