Showing posts with label RCTs. Show all posts
Showing posts with label RCTs. Show all posts
Friday, November 29, 2024

Real world data (RWD) and Real world evidence (RWE) in Drug Development

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The 21st Century Cures Act (Cures Act) , signed into law on December 13, 2016, is designed to accelerate medical product development and bri...
Wednesday, June 19, 2024

Functional Unblinding in Double-blind, Randomized, Controlled Trials (RCTs)

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Earlier this month,  FDA advisory committee declined to endorse Lykos Therapeutics’ application to market its psychedelic drug MDNA, also k...
Sunday, April 21, 2024

Expanded access, compassionate use, and eINDs

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Traditionally, drug approvals relied on at least two adequate and well-controlled studies, each convincing on its own, to establish effectiv...
Sunday, November 19, 2023

RCTs for Chinese Traditional Medicine and Botanical Drug Development

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In the latest issue of JAMA (Journal of American Medical Association), Yang et al published a paper " Traditional Chinese Medicine Com...
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 ...
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...
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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 ...