1. Neither investigators reporting clinical trials nor journal editors selecting reports of trials for publication consistently follow the excellent guidelines published in the biomedical literature.

2. The reporting of data from clinical trials might be more consistent and complete if there were a readily accessible and more concise guide to the most basic methodologic elements required in reports of clinical trials—a checklist.

3. Because the editors of journals publishing reports of clinical trials are the persons best positioned to promote better reporting by the investigators submitting papers to their journals, such a checklist could help journal editors and peer reviewers evaluate the reports of trials submitted for publication.

In response to the call for comments, the Working Group received more than 150 letters from editors, clinicians, clinical investigators, statisticians, and others worldwide, and these letters included many suggestions for revisions or additions. In revising the checklist to reflect those suggestions and the further discussions of the Working Group, every effort was made to address the points raised by correspondents, although compromise was necessary because brevity was a key consideration. The final checklist appears in Table 1; an extended selected bibliography appears at the end of the text.

This checklist might be used to help improve the reporting of clinical trials in several ways. The following are examples.

1. If journal editors incorporate such a checklist into their instructions for authors, it can serve as a framework to guide authors submitting reports of clinical trials.

2. If clinical investigators use the checklist as a quick reference tool in planning and writing reports of their work, reports in the medical literature will become more uniformly complete and useful to clinicians and other investigators.

3. If clinical investigators use the checklist as a teaching tool when training new investigators to plan and write clinical reports, the quality and usefulness of the biomedical literature will continue to improve.

4. If investigators submitting a clinical report indicate on such a checklist the page and line numbers in their manuscript where each item is addressed, the time spent in peer review and editorial decision making can be used more effectively.

5. If peer reviewers use the checklist when evaluating manuscripts for publication, they can foster more uniformly complete and consistent reporting of clinical trials.

In parallel with the efforts of the Asilomar Working Group, the Standards of Reporting Trials (SORT) group, which primarily includes clinical investigators and epidemiologists and biostatisticians, designed a checklist intended specifically to improve the reporting of randomized, controlled trials [2]. Developed independently, the two checklists fulfill remarkably complementary functions. Whereas the Asilomar checklist covers the essential clinical, statistical, structural, and ethical elements necessary to provide a framework for the report of any clinical trial and can be adapted for other types of clinical reports, the SORT checklist details four main areas of content in the report of a randomized, controlled trial: participant assignment, masking, participant follow-up, and approaches to statistical analysis. In September 1995, members of both groups met to collaborate on a focused checklist for randomized, controlled trials that combined the best points of the Asilomar and the SORT checklists. The resulting checklist will be a valuable companion to the Asilomar checklist, providing detail essential to the reporting of randomized, controlled trials and a flow diagram with which to chart the progress of participants through the stages of a trial.

Thorough but concise, the checklist in Table 1 can be used to improve the scientific excellence and clinical usefulness of published reports of clinical trials. Improved reports will provide more consistently complete and reliable information on which clinicians can base their treatment decisions. Such reports will also provide the information needed for an accurate interpretation of findings across several clinical trials and, in the future, for more reliable meta-analyses of all trials on a topic. To encourage the widest possible use of the checklist, it may be copied and reprinted freely, without permission, for educational purposes.

Appendix

Members of the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature:

Journal Editors: Martin L. Fackler, MD, Wound Ballistics Review (Hawthorne, Florida); Edward J. Huth, MD, Annals of Internal Medicine (Philadelphia, Pennsylvania); Roy M. Pitkin, MD, Obstetrics and Gynecology (Los Angeles, California); and Drummond Rennie, MD, Journal of the American Medical Association (Chicago, Illinois) and the University of California, San Francisco (San Francisco, California).

Statisticians: Colin Begg, PhD, Memorial Sloan Kettering Cancer Center (New York, New York); Sander Greenland, MS, DrPH, University of California, Los Angeles (Los Angeles, California); Ingram Olkin, PhD, Stanford University (Stanford, California); and Donna F. Stroup, PhD, MSc, Centers for Disease Control and Prevention (Atlanta, Georgia).

Biomedical Investigators: Dennis F. Deen, PhD, Brain Tumor Research Center, University of California, San Francisco (San Francisco, California); and Joseph Lau, MD, New England Medical Center (Boston, Massachusetts).

Biomedical Editors: Pamela Derish, MA, University of California, San Francisco (San Francisco, California); Susan Eastwood ELS(D), Brain Tumor Research Center, University of California, San Francisco (San Francisco, California); and Thomas Lang, MA, The Cleveland Clinic Foundation (Cleveland, Ohio).

Information Scientist: Kirstin Nichols, MA, ALZA Corp. (Palo Alto, California).

Selected Bibliography of Guidelines for Reporting Clinical Trials

Altman DG, Bland JM. Improving doctors' understanding of statistics. Journal of the Royal Statistical Society. 1991; 54:223-67.

Altman DG, Gore SM, Gardner MJ, Pocock SJ. Statistical guidelines for contributors to medical journals. Br Med J (Clin Res Ed). 1983; 286:1489-93.

Bailar JC 3d, Mosteller F. Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations. Ann Intern Med. 1988; 108:266-73.

Bailar JC 3d, Mosteller F, eds. Medical Uses of Statistics. 2d ed. Boston: NEJM Books; 1992.

Chalmers TC, Smith H Jr, Blackburn B, Silverman B, Schroeder B, Reitman D, et al. A method for assessing the quality of a randomized control trial. Controlled Clin Trials. 1981; 2:31-49.

Cox DR, Oakes D. Analysis of Survival Data. New York: Chapman & Hall; 1984.

Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics. 2d ed. Norwalk, CT: Appleton & Lange; 1994.

Finney DJ, Clarke BC. Guest editorial: code for presentation of statistical analyses. Philosophical Transactions of the Royal Society—London. 1992; 337:381-2.

Glantz SA. Primer of Biostatistics. 3d ed. New York: McGraw-Hill; 1992.

International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals. JAMA. 1993; 269:2282-6.

Lang TA, Secic M. Reporting Statistical Information in Medicine: Annotated Guidelines for Authors, Editors, and Reviewers. Philadelphia: American Coll Physicians; 1996: [In press].

Moher D, Dulberg CS, Wells GA. Statistical power, sample size, and their reporting in randomized controlled trials. JAMA. 1994; 272:122-4.

Murray GD. The task of a statistical referee. Br J Surg. 1988; 75:664-7.

Olkin I. Reconcilable differences: gleaning insight from conflicting scientific studies. The Sciences. 1992; Jul/Aug:30-6.

Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer. 1976; 34:585-612.

Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br J Cancer. 1977; 35:1-39.

Reidenberg MM. The quality of clinical research [Editorial]. Clin Pharmacol Ther. 1990; 47:669-70.

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA. 1995; 273:408-12.

Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA. 1994; 272:125-8.