Sunday, June 26, 2022

Adverse event / serious adverse event data entry when death event occurs

›
If the death event is an efficacy endpoint in the study, should the death event still be reported as AE/SAE?  If the death (or mortality) is...
Sunday, June 19, 2022

Sentinel Dosing (Sentinel Subject) and Staggering Enrollment in First-in-Human (FIH) Clinical Trials

›
First-in-human (FIH) study is a type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time. ...
Thursday, June 09, 2022

Drug Development for Rare Diseases - Public Workshops

›
Drug development for rare diseases is challenging, complex, but absolutely necessary. FDA has special programs to manage and encourage the d...
Monday, May 30, 2022

Clinical trials with external control, historical control, concurrent control, contemporaneous control, and synthetic control

›
Three critical features for modern clinical trials are control, randomization, blinding. For the golden standard of RCTs (randomized control...
Sunday, May 22, 2022

The Use of External Controls in FDA Regulatory Decision Making and Bayesian Borrowing

›
An good article by Jahanshahi et al "The Use of External Controls in FDA Regulatory Decision Making". The authors reviewed and su...
Monday, May 02, 2022

Power of the statistical graphs - an example of different ways for a Bar Chart

›
For the same set of data from the clinical trial, it is important to choose the appropriate statistical analysis methods. It is also importa...
5 comments:
Monday, April 25, 2022

Estimands, Estimator, Estimate, and Estimation

›
With the adoption of ICH E9(R1) " ADDENDUM ON ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS TO THE GUIDELINE ON STATISTICAL PRI...
1 comment:
Monday, April 11, 2022

Randomization and elements of randomization specifications

›
Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignme...
Monday, April 04, 2022

Common Issues in Implementing Randomization and Blinding

›
Randomization and blinding are two techniques to help prevent (conscious or unconscious) bias in clinical trials and they are the cornerston...
Thursday, March 31, 2022

Safety Assessment Committee (SAC), Data Monitoring Committee (DMC), Steering Committee (SC), Clinical Event Committee (CEC)

›
In clinical trials, there are usually different committees established to ensure the study protocol is executable, to ensure the integrity o...
1 comment: