BIOSTATISTICAL APPROACHES IN COVID-19 TRIALS
After all the tensions and confusion, mankind conquered COVID-19 disease through the development of effective vaccine. When you are going through the development history of vaccines, you will come across these terms; ITT Analysis, Toxicity Monitoring, Interim analysis, Immunogenicity, noninferiority, Vaccine efficacy, etc. Yes, these terms are relevant in a novel vaccine development trial. This blog will take you to the biostatistical aspects of vaccine trials.
The duration and efficacy of the clinical trials for COVID-19 vaccine are the most considerable factors for the inventors. These two factors are focused based on statistical decisions. The statistical decisions are very helpful for the pharmaceuticals to get their roles quickly and more effectively. The following statistical areas played an important role in getting the COVID-19 vaccine trails quick and effective.
TRIAL DESIGN
The proper selection of the trial design will give a better accurate quick invention. As per WHO, Phase IIB/III efficacy trials should be randomized, blinded, and placebo-controlled or active-controlled. An individually randomized controlled trial with 1:1 or 2:1 randomization between vaccine and placebo groups is usually the most efficient study design for demonstrating vaccine efficacy. Other types of randomization, such as cluster randomization, may be acceptable if there is evidence that potential biases have been avoided.
INTERIM ANALYSIS
During the development of study, the data will be monitored and analyzed based on the safety and efficacy endpoint using current actual data. If interim Analysis of the data suggests that the vaccine is safe and effective, then the study can be reliably moving forward. Apart from the prediction of the outcome, this analysis should be primarily focused on cost reduction. Sample Sizes and Interim analysis time will be depending on the results coming from the primary and secondary analyses and the realistic nature of the outcomes from the subjects. During the interim analyses, data should be analyzed statistically as same as in the final analysis.
More approaches are available in the following link. Read the full blog at https://genproresearch.com/knowledge/biostatistical-approaches-in-covid-19-trials/
