Clinical Trial Phase

A Clinical Trial Phase is a clinical trial label (study phase ordinal) that differentiates the increased risks taken to determine whether a novel therapy is safe and effective.

• Context:
  • It can (typically) designed to assess different clinical trial measures (e.g. safety, efficacy, and effectiveness).
  • It can (typically) be defined by a government, clinical research expert, or ruling authority.
  • It can be the classification of a Clinical Trial Sub-Task.
  • …
• Example(s):
  • Phase-0 Clinical Trial,
  • Phase-I Clinical Trial,
  • Phase-II Clinical Trial,
  • Phase-III Clinical Trial,
  • Phase-IV Clinical Trial,
  • …
• Counter-Example(s):
  • Phase Not Applicable Clinical Trial,
  • Preclinical Trial.
• See: Medical Diagnosis, Health Intervention, Medical Treatment, Drug Development Clinical Trial, Human Subject Research, Vaccine, Medical Device.

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References

2022

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research Retrieved:2022-1-15.
  • The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

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