The editors of 11 eminent medical journals have written a joint editorial for the May 23 issue of JAMA, Is This Clinical Trial Fully Registered? A Statement From the International Committee of Medical Journal Editors. 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 July 1, 2005. Because many ongoing trials were not registered at inception, we will consider for publication ongoing trials that are registered before September 13, 2005....We recognize that requiring public registration of trials whose prespecified goal is to investigate the biology of disease or to direct further research might slow the forces that drive innovation. Therefore, each journal editor will decide on a case-by-case basis about reviewing unregistered trials in this category. Authors whose trial is unregistered will have to convince the editor that they had a sound rationale when they decided not to register their trial. The ICMJE will maintain this policy for the next 2 years. We will then review our experience. 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 will consider a trial for publication if the authors register it at inception by completing all 20 fields in the WHO minimal data set....We stated our requirements for an acceptable trial registry in the September 2004 editorial,1 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. The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision making.'
(PS: Kudos to the ICMJE journals for reaffirming the open-access condition on their willingness to publish the results of drug trials. This is a good time to consider that the rationale for this policy --"to promote the public good by ensuring that everyone can find key information...whose principal aim is to shape medical decision making"-- also applies to peer-reviewed research literature.)
Update. Today's statement differs from last September's primarily by adding the requirement that drug companies provide 20 specific pieces of information for each drug trial. For a good sense of the reasons why, see Theresa Agovino's story in yesterday's Boston Globe, Editor: Drug firms don't disclose enough. Excerpt: 'The editor-in-chief of the New England Journal of Medicine accused three of the largest drug companies of "making a mockery" of efforts to create transparency in clinical trials, adding that could lead some important medical publications to avoid publishing their studies. Dr. Jeffrey M. Drazen, the editor, said that Pfizer Inc., GlaxoSmithKline PLC and Merck & Co. are not providing enough useful information on clinical trials they register with the government...."They (the three companies) are giving nonsense details," Drazen said in an interview on Monday. "They are written in a way that they are trying to hide what they are doing."'
Posted by
Peter Suber at 5/24/2005 09:49:00 AM.
The open access movement:
Putting peer-reviewed scientific and scholarly literature
on the internet. Making it available free of charge and
free of most copyright and licensing restrictions.
Removing the barriers to serious research.
I recommend the OA tracking project (OATP) as the best way to stay on top of new OA developments. You can read the OATP feed on a blog-like web page or subscribe to it by RSS, email, or Twitter. You can also help build the feed by tagging new developments you encounter.
