Showing posts with label clinical trial design. Show all posts
Showing posts with label clinical trial design. Show all posts
Friday, July 03, 2026

The Rejuvenation Revolution: Inside the First Waves of Human Longevity or Anti-Aging Clinical Trials

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For decades, longevity science was restricted to petri dishes and mouse models. We watched as mice regained their vision, ran farther on tre...
Monday, September 15, 2025

Steroid Tapering Design in Action - Failed

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In a previous post, I discussed steroid tapering design clinical trials . In these trials, the primary efficacy endpoint is the reduction in...
Thursday, December 14, 2023

Defining 'disease modification effect', 'disease modification therapy (DMT)' or 'disease modifier'

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The concept of "disease modification," "disease modification therapy (DMT)," and "disease modifier" has been a...
Friday, October 20, 2023

Human Challenge Study Design in Action - a Dengue Fever vaccine trial

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A human challenge study, also known as a controlled human infection model (CHIM), is a type of clinical research study in which healthy volu...
Sunday, May 21, 2023

Comparing assumptions for sample size estimation with the interim and final results

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Sample size estimation is one of the critical aspects of the clinical trial design. The sample size estimation is usually based on the prima...
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Wednesday, May 17, 2023

Another successful trial with randomized withdrawal design

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Biotech company PTC Therapeutics announced today that their phase III study of Sepiapterin in PKU patients achieved the primary efficacy en...
Monday, February 20, 2023

Open-Label Extension (OLE) Study

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I asked OpenGPT to write a blog article about the open-label extension study and got the following response. The contents from OpenGPT seem ...
Thursday, December 01, 2022

Sample size re-estimation or sample size increase?

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Recently, a press release from a biotech company caught my eye. This seems to be an example of the adaptive design with sample size re-esti...
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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. ...
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...
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...