Phase-2 Controlled Interventional Clinical Study

(Redirected from Phase-II Clinical Trial)
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A Phase-2 Controlled Interventional Clinical Study is a controlled clinical trial that assesses an investigational medical treatment's safety and the initial evaluation of its efficacy and effectiveness.




  • (Wikipedia, 2021) ⇒ Retrieved 2022-01-13.
    • QUOTE: Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect.[1] Phase II trials are performed on larger groups (50–300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Genetic testing is common, particularly when there is evidence of variation in metabolic rate. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.

      Phase II studies are sometimes divided into Phase IIa and Phase IIb. There is no formal definition for these two sub-categories, but generally:

      • Phase IIa studies are usually pilot studies designed to demonstrate clinical efficacy or biological activity ('proof of concept' studies);[2]
      • Phase IIb studies determine the optimal dose at which the drug shows biological activity with minimal side-effects (‘definite dose-finding’ studies).
  1. DeMets D, Friedman L, Furberg C (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN 978-1-4419-1585-6.
  2. Yuan J, Pang H, Tong T, Xi D, Guo W, Mesenbrink P (2016). "Seamless Phase IIa/IIb and enhanced dose-finding adaptive design". Journal of Biopharmaceutical Statistics. 26 (5): 912–23. doi:10.1080/10543406.2015.1094807. PMC 5025390. PMID 26390951.