TY - JOUR
T1 - Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications
AU - Hartung, Daniel M.
AU - Zarin, Deborah A.
AU - Guise, Jeanne Marie
AU - McDonagh, Marian
AU - Paynter, Robin
AU - Helfand, Mark
PY - 2014/4/1
Y1 - 2014/4/1
N2 - 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 industrysponsored, 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.
AB - 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 industrysponsored, 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.
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U2 - 10.7326/M13-0480
DO - 10.7326/M13-0480
M3 - Article
C2 - 24687070
AN - SCOPUS:84897417340
SN - 0003-4819
VL - 160
SP - 477
EP - 483
JO - Annals of internal medicine
JF - Annals of internal medicine
IS - 7
ER -