Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the ClinicalTrials.gov. Here is an overview of this registry:
Registry name: ClinicalTrials.gov
Country: United States of America
Year established: 1997
Points of interest:
- ClinicalTrials.gov is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Information is provided and updated by the clinical trial’s sponsor or principal investigator.
- The registry was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which required the U.S. Department of Health and Human Services (HHS), through NIH, to establish a registry of clinical trials information.
- Congress passed the FDA Amendments Act of 2007 (FDAAA), requiring registration of controlled clinical investigations and certain medical device studies. Learn the details of FDAAA 801 and the Final Rule here: https://clinicaltrials.gov/ct2/manage-recs/fdaaa
- As of February 2019, only 35 percent of registered clinical studies are exclusively located in the U.S.
- There were 293,387 registered clinical trials in 2018, a significant increase from 65,864 a decade prior, in 2008.
- There is no charge for registering studies on ClinicalTrials.gov, as it is a service of the NIH and NLM.
- Protocol registration and results disclosures are mandatory for Phase 2-4 interventional trials. Studies can be registered at any time, even after it has started, closed to recruitment, or been completed
- According to the FDAAA TrialsTracker, nearly 40 percent of clinical trials have not been reported, as of February 2019.
Related transparency research/articles:
- How to register a clinical trial, using ClinicalTrials.gov
- The drug approval process and conducting clinical trials
- ClinicalTrials.gov FAQs
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