About this "amnesty"

ditors of medical journals, indeed all of us who are concerned about obtaining the truth, the whole truth, and nothing but the truth about the efficacy of treatment regimens, have been aware for some years that published evidence from clinical trials can distort reality. Published evidence does not always represent the whole truth. Investigators, editors, and sponsors of clinical trials, want positive results. Studies that yield negative or equivocal results don't so often get submitted for publication, and aren't so often accepted and published in peer-reviewed journals if they are submitted in the first place. This can be a serious source of bias. At the 3rd International Conference on Peer Review, held in Prague in September 97, the medical journal editors who were present agreed to an "amnesty" aimed at encouraging the reporting of unpublished clinical trials, in the interest of more closely approaching the whole truth. This is an ethical issue because distortion of reality in clinical trials reporting is not in the interests of the highest possible standard of medical care–although it may suit certain special interests to allow false impressions about the efficacy of drugs, for instance, to take root and flourish. It is hoped that the clinical trials "amnesty" will help to eradicate these false impressions.

eports of properly conducted randomized 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 publication¹. ² This fact has a number of important implications for patient care.

First, under-reporting 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.

Second, since 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 effective-ness, thus exposing patients to useless or even harmful therapies.

Finally, patients may be asked to participate in new research studies designed to address questions that have, in truth, already been answered.3

Trials go unreported for a myriad of reasons: the most common is that investigators think 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.4 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 unfinished; 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 it.

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– namely 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. We would like to register any unreported controlled trial, including trials that have only been published as abstracts. 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 duplicate registration. Registration information can be posted or faxed to the editorial offices of this journal. Alternatively, registration information can be sent by e-mail (meta@ucl.ac.uk). The information will be made available by listing the trial details on a web site, and in other ways as appro-priate. 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 are confident of a good response.

Unreported-trial registration form

Register any controlled trial which has not been published in full, including trials that have only been published as abstracts. Registration can be undertaken by anyone able to provide the registration information, even if they are unable to provide the actual trial data. Please complete one form for each trial being registered.

References

1. Dickersin K, Min YI. NIH clinical trials and publication bias. On-line J Curr Clin Trials [serial on-line] 1993; Apr 28; 50.
2. Easterbrook PJ, Berlin JA, Gopalan R, Mattews DR. Publication bias in clinical research. Lancet 1991; 337 : 867-72.
3. Egger M, Davey Smith G. Misleading meta-analysis. BMJ 1995; 310 : 752-4.
4. Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability. BMJ 1996; 313 : 390-3.