Showing posts with label adequate & well-controlled study. Show all posts
Showing posts with label adequate & well-controlled study. Show all posts
Sunday, February 22, 2026

From "Two-Trial Dogma" to the Single Pivotal Standard: The Evolution of FDA Evidence Requirements

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The "two-trial" rule was born from the 1962 Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act , which mandate...
Tuesday, November 29, 2022

Randomized withdrawal design in action - Accord trial in Alzheimer's agitation

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The biotech company, Axsome Therapeutics, announced the positive results from one of their pivotal phase 3 studies (Accord study).  Axsome...
2 comments:
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...
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:
Saturday, January 01, 2022

Futility Analysis and Conditional Power When Two Phase 3 Studies are Simultaneously Conducted

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In late-phase clinical trials, an independent Data Monitoring Committee (DMC) is usually set up. If the clinical program includes multiple l...