当前位置： SCI文献检索 > ANNALS OF INTERNAL MEDICINE期刊下所有文献 > Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

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

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.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

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

doi

10.7326/M13-0480

subject

Has Abstract

pub_date

2014-04-01 00:00:00

pages

477-83

issue

eissn

0003-4819

issn

1539-3704

pii

1852869

journal_volume

160

pub_type

杂志文章

在线工具

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