Blog Information

• Posted By : oncology cro
• Posted On : Sep 30, 2022
• Views : 162
• Category : General
• Description : Phase 0 studies are usually performed on healthy individuals. Patients who have already tried the Clinical Trials standard therapies are also eligible to take part in this type of trial.

Overview

• These volunteers are paid a variable amount for their time and inconvenience. Phase II Clinical Trials involve testing new medicines on patients. They can last for several years and are costly. Many trials are terminated due to lack of results or unwanted side effects.
  
  The results of these trials are important for determining the efficacy and safety of a new drug. In addition, they can help in determining whether a given medicine is safe for a particular population.
  
  
  Phase II Clinical Trials are usually conducted in single-arm designs. This design helps avoid some common pitfalls of randomized studies. The first advantage is that it allows researchers to examine the relative effectiveness of different treatments against historical controls.
  
  The Bayesian approach allows researchers to compare results using a binary response variable to determine which treatment is most effective. Phase II Clinical Trials are also conducted in multi-institution settings. The sample size in these trials is usually around 100. The sample size is important, as a high false-positive rate could lead to a negative outcome.
  
  Moreover, over-large targeted differences may lead to the premature termination of potentially beneficial regimens. To limit this risk, Rubinstein et al. recommend a difference of 0.20 between a drug and a placebo regimen in a screening study, and a target difference of 20 percent.