Medical Editors Trial Amnesty (META)

Reports of properly conducted randomised controlled trials are the foundation of safe and effective health care. However, a substantial proportion of all controlled trials never contribute to this knowledge base because they are not submitted for publication.1 2This fact has important implications for patient care. Firstly, underreporting of trials reduces the power of systematic reviews to detect moderate but clinically important treatment effects. As a result, patients may be denied effective forms of health care. Secondly, because trials that show more promising treatment effects are more likely to be submitted for publication, research syntheses based on published studies can give misleading conclusions about treatment effectiveness, thus exposing patients to useless or even harmful therapies.3 Finally, patients may be asked to participate in new research studies designed to consider questions that have, in truth, already been answered.4

Trials go unreported for a myriad of reasons: the most common is that investigators think that the results are “not interesting”, and it is well documented that trials with non-significant results are substantially less likely to be submitted for publication.1 Sometimes participant recruitment takes longer than anticipated at the expense of time and resources set aside for report writing; investigators may change jobs with the result that important work remains finished; or an investigator may discover a recently published trial on the same topic and conclude that their own results are now redundant. Editors must also take some of the responsibility. There is a limit to the number of reports we can publish and sometimes we are forced to decline publication. Many investigators regret not having published their trial results, and almost all investigators when contacted about unreported data are delighted to provide them.

Because of the important consequences of unreported trials, the editors of nearly 100 international medical journals have joined together to call an unreported trial amnesty. Although amnesty means giving pardon, we hope that investigators will see this as an opportunity to make the results of previously unreported trials publicly accessible, thus having the potential to contribute to the scientific foundation of health care. We urge all investigators with unreported trial data to register their trial or trials by filling in and returning an unreported trial registration form (see p 3 in this volume). We would like to register any unreported controlled trial, including trials that have only been published as an abstract. Registration can be undertaken by anyone able to provide the registration information, even if they are unable to provide the actual trial data. We expect a degree of duplication registration. Registration information can be posted or faxed to the editorial office of the JNNP. Alternately, it can be sent by email (meta{at}ucl.ac.uk). The information will be made available by listing the trial details on a web site, and in other ways as appropriate. If specific trial data are required—for example, by those conducting systematic reviews—then the reviewer will be able to seek this information directly from the trialist. Some of the trials may be suitable for full publication, and the Journal will be happy to consider these.

Medical editors are acutely aware of the trials and tribulations of research reporting but on this occasion, because of the serious implications of unreported research, we are endeavouring to cleave the trials from the tribulations. We cannot confidently estimate the total number of unreported trials, but we expect a good response.

For the Medical Editors Trial Amnesty