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...
Monday, April 04, 2022

Common Issues in Implementing Randomization and Blinding

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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)

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In clinical trials, there are usually different committees established to ensure the study protocol is executable, to ensure the integrity o...
1 comment:
Monday, February 28, 2022

Human Preclinical Studies and Phase 0 Clinical Trials

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The drug development process includes various steps from discovery (discovery of a new compound or biological product) to preclinical resear...
4 comments:
Tuesday, February 08, 2022

FDA's Priority Review Voucher for COVID-19 Vaccine

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 To spur drug development in the under-developed area, FDA relies on various policies and programs to incentify the biotech and pharmaceutic...
2 comments:
Tuesday, February 01, 2022

Randomization, Re-Randomization, and Micro-Randomization

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 I recently saw a Twitter post mentioning " Micro-Randomized Study Design Example - Maryland Alcohol-Dependent Moms Abstinence (MAMA) S...