Controlled Formal Human Inverventional Study

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).

• AKA: In-Vivo Clinical Trial.
• Context:
  • It is based on In-Vivo Experiments.
  • It can range from being a Drug Development Clinical Trial, to being a Vaccine Development Clinical Trial, to being a Medical Device Clinical Trial, to being a Diagnostic Assay Clinical Trial.
• Example(s):
  • Phase-0 Clinical Trial,
  • Phase-I Clinical Trial,
  • Phase-II Clinical Trial,
  • Phase-III Clinical Trial,
  • Phase-IV Clinical Trial,
  • Phase Not Applicable Clinical Trial,
  • …
• Counter-Example(s):
  • a Controlled Formal Veterinary Inverventional Study.
  • In-Vivo Preclinical Trial,
  • In-Vitro Preclinical Trial.
• See: Decentralized Clinical Trial, Clinical Research, Placebo Effect, Animal Testing.

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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. 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	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

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