What is a Phase IIA study?
Phase IIa Clinical Trial means a relatively small Phase II Clinical Study designed to study the effectiveness of a particular Product against placebo or other positive controls for a particular indication in patients with the disease or condition under study, including narrowing the optimal dose, the potential utility.
What is clinical trial comparative study?
Controlled (sometimes synonym “comparative” is used) clinical study is the trial in which the investigational drug whose efficacy and safety are not fully studied is compared with the agent whose efficacy and safety are well known (comparator drug). Comparator can be placebo, standard therapy or no treatment at all.
What is a comparative trial?
Comparative effectiveness clinical trials are randomized comparisons of treatments designed to determine which treatment options are superior in order to help better inform decision makers.
What is a comparative effectiveness trial?
Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial.
What is a Phase 4 study?
A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. Phase IV clinical trials may include thousands of people. Also called phase 4 clinical trial and post-marketing surveillance trial.
What are the different types of clinical trials?
Types of clinical trials
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.
What is a randomized comparative trial?
study in which a participant is randomly assigned to one of two or more different treatment groups for purposes of comparing the effects of the treatments.