Sunday, July 26, 2020

Blinding and Masking Issue in Covid-19 Vaccine Clinical Trials

›
Clinical trials for Covid-19 vaccine development are moving into the critical late phase stage. The front runners right now are Moderna (in ...
7 comments:
Sunday, July 19, 2020

Waterfall plot(s) to display the results in oncology and non-oncology clinical trials

›
The waterfall plot(s) started as a visualization tool in oncology studies to display the results of tumor burden, tumor size (or change in t...
6 comments:
Sunday, July 05, 2020

FDA Guidance "Development and Licensure of Vaccines to Prevent COVID-19" - sample size situation for phase 3 studies

›
Last week, FDA issued its guidance for industry " Development and Licensure of Vaccines to Prevent COVID-19 ". Unlike the usual FD...
Sunday, June 28, 2020

Sample Size for COVID-19 Vaccine Phase 3 Study

›
Vaccine development for COVID-19 is at historic speed. Several companies have already had vaccines in the early phase of clinical trials. Le...
1 comment:
Friday, June 12, 2020

Neutralizing Antibodies: Active Immunization and Passive Immunization Against Covid-19

›
Generally speaking, a person achieves immunity to disease through the presence of neutralizing antibodies, or proteins produced by the body ...
1 comment:
Wednesday, June 10, 2020

Coronavirus Vaccine Tracker - Developing Vaccines Against Covid-19

›
Ultimately, to win the battle against the Covid-19, we will rely on a safe and effective available in very large quantities. Pharmaceutical ...
Sunday, June 07, 2020

Should Drug Safety (or Pharmacovigilence) Group be Provided with the Randomization Schedule for Blinded Studies?

›
To avoid the conscious and unconscious bias in safety and efficacy assessment, clinical trials are usually designed as double-blinded studie...
1 comment:
Tuesday, May 26, 2020

Binding Antibodies, nonneutralizing antibodies (n-NAbs), and Neutralizing Antibodies (NAbs)

›
Last Monday, Moderna announced the positive results from its phase I clinical trial for its mRNA vaccine against Covid-19. The study was lis...
1 comment: