Question

How many phases of clinical studies are there write your answer in numeric from

Answer 1

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.[1] 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.[1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

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SummaryEdit

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.[1] Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over several years.[1]

Summary of clinical trial phasesPhasePrimary goalDosePatient monitorTypical number of participantsSuccess rate[2]NotesPreclinicalTesting of drug in non-human subjects to gather efficacy, toxicity and pharmacokinetic informationUnrestrictedScientific researcherNo human subjects, in vitro and in vivo onlyIncludes testing in model organisms. Human immortalized cell lines and other human tissues may also be used.Phase 0Pharmacokinetics; particularly oral bioavailability and half-life of the drugSmall, subtherapeuticClinical researcher10 peopleOften skipped for Phase I.Phase IDose-ranging on healthy volunteers for safetyOften subtherapeutic, but with ascending dosesClinical researcher20–100 normal healthy volunteers (or cancer patients for cancer drugs)Approx. 70%Determines whether drug is safe to check for efficacy.Phase IITesting of drug on participants to assess efficacy and side effectsTherapeutic doseClinical researcher100–300 participants with a specific diseasesApprox. 33%Determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effectPhase IIITesting of drug on participants to assess efficacy, effectiveness and safetyTherapeutic doseClinical researcher and personal physician300–3,000 people with a specific disease25–30%Determines a drug's therapeutic effect; at this point, the drug is presumed to have some effectPhase IVPost marketing surveillance in publicTherapeutic dosePersonal physicianAnyone seeking treatment from a physicianN/AMonitor long-term effects

Answer 2

Answer:

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