LETTER
Recommendations for Reporting Clinical Trials
Thomas A. Marciniak, MD
1 March 1997 | Volume 126 Issue 5 | Page 411
TO THE EDITOR:
The recent recommendations by the Asilomar Working Group [1] represent a major advance toward improving the reporting of clinical trial results, but have we forgotten so quickly the lessons of last year? The most serious recent threat to the validity of clinical trial results was the falsification of data by an investigator [2]. The current checklist does not require the reporting of procedures, such as independent audits, to counter such a threat. The checklist also does not suggest the reporting of procedures and results regarding other aspects of data integrity (for example, quality of data). I urge that the following items be added to the checklist: First, the Methods section of the checklist should include the following: "Procedures ensuring data integrity and quality (for example, independent audits of data collection, blind reabstractions, reference laboratory use)." Second, the Results section should include the following: "Measures of data quality (for example, interrater reliability statistics, measurement error estimates for all variables used in analyses)."
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Author and Article Information
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Rockville, MD 20852
1. Checklist of information for inclusion in reports of clinical trials. The Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1996; 124:741-3.
2. Fisher B, Redmond CK. Fraud in breast cancer trials. N Engl J Med. 1994; 330:1458-60.
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