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

Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M.

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.