PUBLICATIONS

Abstract

Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.


Hartung DM, Zarin D, Guise JM, McDonagh M, Paynter R, Helfand M

Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.

Abstract:

BACKGROUND ClinicalTrials.gov requires reporting of result summaries for many drug and device trials. PURPOSE To evaluate the consistency of reporting of trials that are registered in the ClinicalTrials.gov results database and published in the literature. DATA SOURCES ClinicalTrials.gov results database and matched publications identified through ClinicalTrials.gov and a manual search of 2 electronic databases. STUDY SELECTION 10% random sample of phase 3 or 4 trials with results in the ClinicalTrials.gov results database, completed before 1 January 2009, with 2 or more groups. DATA EXTRACTION One reviewer extracted data about trial design and results from the results database and matching publications. A subsample was independently verified. DATA SYNTHESIS Of 110 trials with results, most were industry-sponsored, parallel-design drug studies. The most common inconsistency was the number of secondary outcome measures reported (80%). Sixteen trials (15%) reported the primary outcome description inconsistently, and 22 (20%) reported the primary outcome value inconsistently. Thirty-eight trials inconsistently reported the number of individuals with a serious adverse event (SAE); of these, 33 (87%) reported more SAEs in ClinicalTrials.gov. Among the 84 trials that reported SAEs in ClinicalTrials.gov, 11 publications did not mention SAEs, 5 reported them as zero or not occurring, and 21 reported a different number of SAEs. Among 29 trials that reported deaths in ClinicalTrials.gov, 28% differed from the matched publication. LIMITATION Small sample that included earliest results posted to the database. CONCLUSION Reporting discrepancies between the ClinicalTrials.gov results database and matching publications are common. Which source contains the more accurate account of results is unclear, although ClinicalTrials.gov may provide a more comprehensive description of adverse events than the publication. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.


Hartung DM, Zarin D, Guise JM, McDonagh M, Paynter R, Helfand M Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. 
Ann Intern Med. 2014 Apr 1;160(7):477-83. doi: 10.7326/M13-0480.

PMID | PMCID