Controlled Formal Human Inverventional Study

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A Controlled Formal Human Inverventional Study is a controlled clinical trial that is a human clinical study (conducted to test the effects of a new medical intervention/treatment or medical product in humans).



References

2022

  • (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Summary Retrieved:2022-1-15.
    • QUOTE: Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years.[1] If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over several years.
Summary of clinical trial phases
Phase Primary goal Dose Patient monitor Typical number of participants Success rate[2] Notes
Preclinical Testing of drug in non-human subjects to gather efficacy, toxicity and pharmacokinetic information Unrestricted Scientific researcher No human subjects, in vitro and in vivo only Includes testing in model organisms. Human immortalized cell lines and other human tissues may also be used.
Phase 0 Pharmacokinetics; particularly oral bioavailability and half-life of the drug Small, subtherapeutic Clinical researcher 10 people Often skipped for Phase I.
Phase I Dose-ranging on healthy volunteers for safety Often subtherapeutic, but with ascending doses Clinical researcher 20–100 normal healthy volunteers (or cancer patients for cancer drugs) Approx. 70% Determines whether drug is safe to check for efficacy.
Phase II Testing of drug on participants to assess efficacy and side effects Therapeutic dose Clinical researcher 100–300 participants with a specific disease Approx. 33% Determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect
Phase III Testing of drug on participants to assess efficacy, effectiveness and safety Therapeutic dose Clinical researcher and personal physician 300–3,000 people with a specific disease 25–30% Determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect
Phase IV Post marketing surveillance in public Therapeutic dose Personal physician Anyone seeking treatment from a physician N/A Monitor long-term effects

  1. "The drug development process". US Food and Drug Administration. 4 January 2018. Retrieved 17 August 2020.
  2. "Step 3. Clinical research". US Food and Drug Administration. 14 October 2016. https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm. Retrieved 1 February 2017.