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POSITION PAPER

Call for Comments on a Proposal To Improve Reporting of Clinical Trials in the Biomedical Literature

Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature.

1 December 1994 | Volume 121 Issue 11 | Pages 894-895

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Published guidelines for reporting clinical-research data range from the succinct paragraph on statistics in the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" [1] to articles of differing detail [2-7] and books written for the clinical researcher [8-10]. Despite such excellent resources in the biomedical literature, neither investigators reporting clinical trials nor journal editors selecting reports of trials for publication follow those guidelines consistently. For this reason, a working group of medical journal editors, biostatisticians, researchers, and editors from biomedical institutions met to consider how reporting of clinical-trials data might be made more consistent and complete. The group proposed that 1) editors of journals publishing reports of clinical trials are the persons best positioned to promote better reporting by investigators submitting papers to their journals, and 2) a readily accessible guide to the most basic methodologic elements required in reports of clinical trials could be helpful to journal editors and peer reviewers in evaluating reports of trials submitted for publication.

On this basis, the group drafted the following checklist Table 1 and a proposal for its use: If journal editors incorporate such a checklist in their "Instructions for Authors," it can serve as a framework for authors submitting reports of clinical trials. If journal editors ask their peer-review panels to use such a checklist in evaluating the selection of manuscripts for publication, it can foster more uniformly complete and consistent reporting of clinical trials. Such a checklist could also be helpful to clinical investigators as a quick reference tool in planning and writing reports of their work and as a training tool for clinical trainees.

View this table: [in this window] [in a new window]   Table 1. Checklist of Information for Inclusion in Reports of Clinical Trials

 

Adequate statistical reporting of data from clinical trials must follow detailed, comprehensive guidelines, and this checklist can serve as no more than a reminder. Nonetheless, authors of clinical trials who use this checklist to report data would provide clinicians with more consistently complete and reliable information on which to base treatment decisions. They would also provide clinical investigators with the information needed for an accurate interpretation of findings across several clinical trials and, in the future, for more reliable meta-analyses [11] of all trials on a topic.

With the generous cooperation of several professional medical, statistical, and scientific editors' societies, this checklist is being disseminated as widely as possible for consideration and comment by editors of medical journals, clinical investigators, biostatisticians, and others who would benefit from more uniform reporting of clinical-trials data. The working group would appreciate receiving your comments on this checklist, the potential value of its use by authors if it were published in the "Instructions for Authors" section of different journals, and its usefulness to journal editors and reviewers as a tool for peer review. Please send your suggestions and comments by 15 March 1995 to: Working Group, c/o Neurosurgery Editorial Office, 1360 Ninth Avenue, Suite 210, San Francisco, CA 94122. If you wish to receive a copy of the final checklist, please send a stamped, self-addressed envelope or $1.00 U.S. equivalent for postage to this address, and it will be mailed to you as soon as possible.

Appendix

Members of the Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, which met at the Asilomar Conference Grounds, Pacific Grove, California, 14 to 16 March 1994. Journal Editors: Martin L. Fackler, MD, Wound Ballistics Review (Hawthorne, Florida); Edward J. Huth, MD, Annals of Internal Medicine and The On-Line Journal of Clinical Trials (Philadelphia, Pennsylvania); Roy M. Pitkin, MD, Obstetrics and Gynecology (Los Angeles, California); Drummond Rennie, MD, Journal of the American Medical Association and University of California, San Francisco (San Francisco, California); Statisticians: Colin Begg, PhD, Memorial Sloan Kettering Cancer Center (New York, New York); Sander Greenland, DrPH, University of California, Los Angeles (Los Angeles, California); Ingram Olkin, PhD, Stanford University (Stanford, California); 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, California); 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), University of California, San Francisco (San Francisco, California); Thomas Lang, MA, The Cleveland Clinic Foundation (Cleveland, Ohio); Information Scientist: Kirstin Nichols, MA, ALZA Corporation (Palo Alto, California). The working group appreciates support provided by the Asilomar Western Regional Conference and Northern California Chapter of the American Medical Writers Association.

Author and Article Information

Top Author & Article Info References

For members of the Working Group, see the Appendix.
Requests for Reprints: Susan Eastwood, ELS(D), Department of Neurological Surgery, Box 0926, c/o The Editorial Office, 1360 Ninth Avenue, Suite 210, San Francisco, CA 94122.

References

Top Author & Article Info References

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

2. Altman DG, Bland JM. Improving doctors' understanding of statistics. J R Statist Soc A. 1991; 54(Pt 2):223-67.

3. Altman DG, Gore SM, Gardner MJ, Popcock SJ. Statistical guidelines for contributors to medical journals. Br Med J. 1983; 286:1489-93.

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

5. 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.

6. Finney DJ, Clarke BC. Guest editorial: code for presentation of statistical analyses. Phil Trans R Soc Lond B. 1992; 337:381-2 (code first appeared in Proc R Soc Lond B. 1992; 249:1-2).

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

8. Bailar JC 3d, Mosteller F, eds. Medical Uses of Statistics. 2nd ed. Waltham, Massachusetts: NEJM Books; 1992:449.

9. Glantz SA. Primer of Biostatistics. 3rd ed. New York: McGraw-Hill; 1992; 440.

10. Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics. 2nd ed. Norwalk, Connecticut: Appleton & Lange; 1994:344.

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

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