ClinicalTrials.gov: The Tip of the Iceberg
Posted on August 13, 2014 by Kelli Hines | No Comments
We all know that ClinicalTrials.gov is a great resource for searching for current, completed, or recruiting trials. The same resource, however, can provide a great deal more information to researchers. Federal law requires that interventional trials of FDA-approved drugs, biologics and devices, initiated after September 2007 with at least one site in the US must post results to Clinicaltrials.gov within one year of completion of the trial. Results are submitted in a series of data tables with supporting notes, but no narrative. They include participant flow, baseline characteristics, outcome measures and statistical analyses, and adverse events.
The reason this is important is that there are a number of clinical trials that are never published. Trials that are published may not include as much detail in the reporting of results as those submitted to ClinicalTrials.gov. According to a recently published study, Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals, of the 600 completed trials included in the study’s sample about 50% had no published article. For trials whose results were submitted and published the authors report that there was a significant difference in reporting levels between the published article and ClinicalTrials.gov, with more complete results for flow of participants, efficacy results, adverse and serious adverse events at ClinicalTrials.gov.
When doing your research, search ClincialTrials.gov for the results of published and unpublished trials.
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