Reports of properly conducted randomized, controlled trials are the foundation of safe and effective health care. However, a substantial proportion of all such trials never contribute to our knowledge base because they are not submitted for publication [1, 2]. This fact has several important implications for patient care. First, 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. Second, 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, thereby exposing patients to useless or even harmful therapies [3]. Finally, patients may be asked to participate in new research studies designed to address questions that have already been answered [4].
Trials go unreported for myriad reasons; the most common is that investigators think the results are "not interesting," and it is well documented that trials with nonsignificant 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 unfinished; or investigators may discover a recently published trial on the same topic and conclude that their own results are redundant. Editors must also take some of the responsibility. There is a limit to the number of reports we can publish, and we are sometimes 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 for what amounts to 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, with 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 those with results that have been published only in abstract form. Registration can be undertaken by anyone able to provide the registration information, even if he or she is unable to provide the actual trial data. We expect a degree of duplicate registration. Registration information can be mailed or faxed to the editorial offices of Annals or sent by e-mail to metaucl.ac.uk. The information will be made available through a listing of trial details on a World Wide Web site and in other ways, as appropriate. If specific trial data are required (for example, by persons conducting systematic reviews), the reviewer will be able to seek this information directly from the trialists. Some of the trials may be suitable for full publication, and Annals will be happy to consider these if they are formally submitted according to the specifications given in our Information for Authors.
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 endeavoring to cleave the trials from the tribulations. We cannot confidently estimate the total number of unreported trials, but we hope for a good response.
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Unreported Trial Registration Form
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Register any controlled trial that has not been published in full, including trials with results that have been published only in abstract form. Registration can be undertaken by anyone able to provide the registration information, even if he or she is unable to provide the actual trial data. Please complete one form for each trial being registered.
Contact Details
Last name: ____________________
First name: ____________________
Postal address: ____________________
Telephone number (with area code): ____________________
Fax number (with area code): ____________________
E-mail address: ____________________
Trial Details
Approximate number of participants in the trial: ____________________
Type of participants (e.g., persons with head injury, women at risk for breast cancer): ___________________
Type of intervention (e.g., steroids versus placebo, annual mammography versus standard practice): ____________________
versus
____________________
Please mail or fax completed registration forms to
Medical Editors Trial Amnesty
Annals of Internal Medicine
Independence Mall West
Sixth Street at Race
Philadelphia, PA 19106
Fax: 215-351-2644
The above information can also be sent by e-mail to metaucl.ac.uk.
Frank Davidoff, MD
On Behalf of the Medical Editors Trial Amnesty
1. Dickersin K, Min YI. NIH clinical trials and publication bias. J Curr Clin Trials [serial on-line]. 28 April 1993; Doc. No. 50.
2. Easterbrook PJ, Berlin JA, Gopalan R, Matthews 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; 313:1390-3.
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