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Evaluating the Completeness of ClinicalTrials.gov
Stella Stergiopoulos1, Kenneth A Getz1, Christine Blazynski2
11 Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA.
Therapeutic Innovation & Regulatory Science
|July 27, 2018
Summary
This study found significant discrepancies in clinical trial site and country data between ClinicalTrials.gov and Trialtrove. Caution is advised when using ClinicalTrials.gov alone for landscape assessments.
Area of Science:
- Clinical research informatics
- Biomedical data management
- Health services research
Background:
- Limited research exists on the accuracy and completeness of clinical trial site information on ClinicalTrials.gov.
- Existing studies primarily focus on compliance with listing trial information, not data accuracy.
Purpose of the Study:
- To assess the completeness and accuracy of clinical trial site information on ClinicalTrials.gov.
- To compare data from ClinicalTrials.gov with a commercial database, Trialtrove.
Main Methods:
- A head-to-head comparison of clinical trial data from ClinicalTrials.gov and Trialtrove for breast cancer, non-small cell lung cancer, type 2 diabetes mellitus, and pain.
- Analysis of specific data fields including trial counts, site information, country, enrollment, status, phase, and start year for trials with identical NCT numbers.
Main Results:
- Trialtrove captured 31% more trials than ClinicalTrials.gov for the selected indications.
- Clinical trial site information was identical in only 48% of cases, country information in 82%, and enrollment figures in 86%.
- Discrepancies were noted in clinical trial status, phase, and start year between the two databases.
Conclusions:
- This study establishes a baseline for evaluating ClinicalTrials.gov reporting practices against NIH and HHS requirements.
- Significant variations in site and country data suggest caution when relying solely on ClinicalTrials.gov for clinical trial landscape assessment.
- The comparative accuracy of ClinicalTrials.gov versus Trialtrove could not be definitively determined.
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