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.
- AKA: Phase II CT.
- Context:
- It can (typically) be considered a human clinical trial's second learning phase.
- It can (often) involve of 30-300 clinical trial participants.
- It is conducted to evaluate whether a new medical intervention/treatment works.
- It can (typically) continue to collect data on safety and side effects.
- It can range from being an Uncontrolled Phase-II Clinical Trial (less often) to being a Controlled Phase-II Clinical Trial (more often).
- It can range from being a Phase-IIa Clinical Trial to being a Phase-IIb Clinical Trial.
- …
- Example(s):
- Counter-Example(s):
- See: Parallel Clinical Trial, Factorial Clinical Trial, Large-Simple Clinical Trial, Adaptive Clinical Trial.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#P Retrieved: 2022-01-13.
- QUOTE: Phase I/II trial
- A trial to study the safety, dosage levels, and response to a new treatment. (NCI)
- Phase II clinical trials
- A study to test whether a new treatment has an effect (NCI)
- Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. (NLM)
- Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. (21CFR312)
- Phase II/III trial
- A trial to study response to a new treatment and the effectiveness of the treatment compared with the standard treatment regimen. (NCI)
- QUOTE: Phase I/II trial
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Phase_II 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).
- 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.
- ↑ DeMets D, Friedman L, Furberg C (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN 978-1-4419-1585-6.
- ↑ 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.
2021c
- (ClinicalTrials.gov, 2021) ⇒ https://clinicaltrials.gov/ct2/about-studies/glossary Retrieved 2022-01-13.
- QUOTE: Phase 2: A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
2021d
- (Coursera, 2021) ⇒ "Design and Interpretation of Clinical Trials".
- QUOTE: Phases I and II are often considered the learning phases of clinical trials, and phase III is considered the demonstration phase.
Phase IV studies: these are studies of a drug or device after market approval. The objective of phase IV studies is to see how an intervention works in the real world and to examine long-term safety. Phase IV studies are frequently observational, but sometimes they are control trials.
- QUOTE: Phases I and II are often considered the learning phases of clinical trials, and phase III is considered the demonstration phase.