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Tuesday, July 19, 2005

More on OA to clinical trial data

Is This Clinical Trial Fully Registered? A Statement from the International Committee of Medical Journal Editors. Annals of Internal Medicine, July 19, 2005. Excerpt:
In September 2004, the members of the International Committee of Medical Journal Editors (ICMJE) published a joint editorial aimed at promoting registration of all clinical trials. We stated that we will consider a trial for publication only if it has been registered before the enrollment of the first patient. This policy applies to trials that start recruiting on or after 1 July 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before 13 September 2005. Our goal then and now is to foster a comprehensive, publicly available database of clinical trials. A complete registry of trials would be a fitting way to thank the thousands of participants who have placed themselves at risk by volunteering for clinical trials. They deserve to know that the information that accrues from their altruism is part of the public record, where it is available to guide decisions about patient care, and deserve to know that decisions about their care rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish....Our September 2004 editorial specified the information that we would require for trial registration. Attendees at a recent meeting of the WHO registration advisory group identified a minimal registration data set of 20 items (Table). The WHO-mandated items collectively address every key requirement that we established in our September 2004 editorial. The ICMJE supports the WHO minimal data set and has adopted it as the ICMJE's requirement....We stated our requirements for an acceptable trial registry in the September 2004 editorial, and they remain the same. The registry must be electronically searchable and accessible to the public at no charge. It must be open to all registrants and not for profit. It must have a mechanism to ensure the validity of the registration data.