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How to read a ClinicalTrials.gov record without overclaiming
A field-by-field guide to study status, sponsor, design, outcomes, enrollment, posted results, and record history.
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Réponse directe
Read a ClinicalTrials.gov record in this order: study type and status, sponsor, enrollment, allocation and masking, primary outcomes and time frames, eligibility, posted results, and version history. A registered or completed study is not automatically a positive study, and the registry does not certify scientific accuracy.
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- Registration documents a plan and status; it does not establish benefit.
- Primary outcomes and time frames are more important than the brief summary.
- Posted results and adverse events can exist without a journal publication.
- The version history helps identify changes made after registration.
Start with status and responsibility
Identify whether the record describes an interventional or observational study, then read recruitment status and completion dates. Note the sponsor and collaborators because they are responsible for the submitted information.
ClinicalTrials.gov explains that the National Library of Medicine performs limited quality-control review. Sponsors and investigators remain responsible for accuracy, and posted results are not reviewed for scientific correctness.
Read the prespecified design
For an interventional study, inspect allocation, intervention model, masking, comparator, enrollment, and eligibility. Then read each primary outcome, its measurement, and its time frame before looking at secondary outcomes.
A vague title can hide a narrow question. The primary outcome defines the central test more reliably than promotional language around the study.
Connect the record to results and publications
If the Results tab is present, inspect participant flow, baseline characteristics, outcome tables, and adverse events. Search the registry identifier in PubMed to find related publications.
Finally, open the record history and compare early versions with later ones. Changes are not automatically improper, but they may change how the eventual result should be interpreted.
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Sources
- 01U.S. National Library of Medicine
- 02U.S. National Library of Medicine
- 03U.S. National Library of Medicine
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