ClinicalTrials.gov Registry

A ClinicalTrials.gov Registry is a clinical trials registry.

• Context:
  • It can be supported by a ClinicalTrials.gov Database.
  • …
• Example(s):
  • …
• Counter-Example(s):
  • WHO International Clinical Trials Registry Platform (ICTRP).
  • EudraCT (European Union Drug Regulating Authorities Clinical Trials).
  • Aggregate Analysis of ClinicalTrials.gov (AACT) Database.
  • …
• See: National Institutes of Health, Citeline Organization, United States National Library of Medicine, FDA Modernization Act of 1997, ClinicalTrials.gov Glossary.

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References

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/ClinicalTrials.gov Retrieved:2021-11-23.
  • ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, holding registrations from over 329,000 trials from 209 countries.

2018

• (Zarin et al., 2018) ⇒ Deborah A. Zarin, Rebecca J. Williams, Tony Tse, and Nicholas C. Ide. (2018). “The Role and Importance of Clinical Trial Registries and Results Databases.” In: Principles and Practice of Clinical Research. Academic Press.
  • QUOTE: Clinical Trials.gov uses the following definitions to distinguish between interventional and observation studies 3⁹.
• Interventional: A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by a study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
• Observational: A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions as part of their routine care, but the investigator does not assign participants to specific interventions (as in an interventional study).

The key factor in differentiating between these study types is whether the individual received a specific inter vention based on assignment by an investigator accord ing to a research protocol. A common misconception is that studies of diagnostic interventions are not interven tional. For example, some studies that investigators consider to be observational or epidemiologic use exper imental diagnostic tests as part of the design. Use of these tests makes the study interventional because such participants are being exposed to an intervention as a consequence of the research protocol; they would not have received that intervention had they not been in the study. This would also be true if the study involves the use of an approved diagnostic test (e.g., a positron emission tomography scan) with greater frequency or in a different manner than would have. occurred had the individual not been included in the study.

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