Q&A: Fasering van klinische proeven

by 17 December 2022 · Science & Research

Klik op de afbeelding voor een grotere weergave (via Box.net)

Op Wikipedia wordt met een overzichtelijke tabel op beknopte wijze de fasering van klinische proeven uitgelegd. Met behulp van deze informatie heb ik een iets fraaiere weergave van de tabel gemaakt.

Klik op de afbeelding voor een grotere weergave.

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 Ia: In single ascending dose studies, small groups of subjects are given a single dose of the drug while they are observed and tested for a period of time to confirm safety.
  • Phase Ib: Multiple ascending dose studies investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug, looking at safety and tolerability.
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 IIa studies are usually pilot studies designed to demonstrate clinical efficacy or biological activity (‘proof of concept’ studies);
  • Phase IIb studies determine the optimal dose at which the drug shows biological activity with minimal side-effects (‘definite dose-finding’ studies).
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

bron: https://en.wikipedia.org/wiki/Phases_of_clinical_research (geraadpleegd 23 oktober 2022).

Tags:

Pages

Nieuwsbrief

Meld je aan voor de Nieuwsbrief voor Goede Onderzoekspraktijken en blijf op de hoogte van nieuws en ontwikkelingen rond medisch-wetenschappelijk onderzoek. Klik hier om je aan te melden

Follow me on Bluesky

Nieuws van de CCMO

Nieuws van de DCRF