Monday, August 22, 2022

Story of BrainStorm's Stem Cell Treatment for ALS - Criticality of the Statistical Analyses

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This past week, the biotech company BrainStorm announced the decision to submit a BLA to the FDA for NurOwn® (a stem cell treatment) for th...
Sunday, August 21, 2022

Mediation analysis and SAS CAUSALMED procedure

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In a recent publication (Benza et al " Contemporary Risk Scores Predict Clinical Worsening in Pulmonary Arterial Hypertension - An Anal...
Thursday, August 18, 2022

Handling of values below or above a threshold (Below the Low Limit of Quantification or Above the Upper Limit of Quantification)?

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In clinical trials, the samples are often collected and sent to the central laboratory or specialty laboratory for measuring certain paramet...
Monday, August 01, 2022

Placebo effect and its impact on the overall treatment effect

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RCTs (randomized, controlled clinical trials) are still the golden standard in clinical research. In RCTs, the most common control group is ...
Friday, July 29, 2022

CRO, ARO, and VRO - All types of clinical research organizations

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CRO (Contract Research Organization or Clinical Research Organization) A CRO is a company that provides clinical trial management services f...
2 comments:
Sunday, June 26, 2022

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

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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

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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

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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

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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

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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

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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

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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

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Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignme...