![]() Statistical basis for the quantitative evaluation of the evidence relating to treatment effects. During subsequent analysis of the trial data, it provides a sound Randomisation introduces a deliberate element of chance into the assignment of treatments to ICH Topic E 9Statistical Principles for Clinical Trials has an entire section discussing randomization as the key design technique to avoid biases: Bias occurs when a trial's results are affected by human choices or other factors not related to the treatment being tested. At several points during and at the end of the clinical trial, researchers compare the groups to see which treatment is more effective or has fewer side effects. ![]() In the simplest trial design (parallel-group design), the investigational group receives the new treatment and the control group receives standard therapy. Randomization is the process of assigning subjects (patients, clinical trial participants) by chance to groups that receive different treatments. Based on the number of times that a subject can be randomized in a study, we can differentiate the studies as randomized, re-randomized, and micro-randomized trials. I recently saw a Twitter post mentioning " Micro-Randomized Study Design Example - Maryland Alcohol-Dependent Moms Abstinence (MAMA) Study" and found the term 'micro-randomization' interesting and prompted me to compare the concept of randomization, re-randomization, and micro-randomization.
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