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Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to composite covariates
In May 2023, the FDA has unveiled its definitive guidance titled “Adjusting for Covariates in Randomized Clinical Trials (RCT) for Drugs and Biological Products”. This guidance marks a pivotal moment…
Is the placebo effect contagious between investigators and patients?
A recent study published in Nature Human Behavior developed a methodology to understand and assess the role of physician expectation on the placebo response. Read more about…
Tools4Patient Introduces New Brand and Website
Tools4Patient is committed to our mission of developing predictive tools to optimize the evaluation of clinical-stage drugs. Along with our recent launch of Placebell©™ – a predictive…
Identification Of Peripheral Neuropathic Pain Sensory Phenotypes Based On Specific Combinations Of Symptoms Identified With The NPSI (Neuropathic Pain Symptom Inventory)
One way to better personalized the treatment of peripheral neuropathic pain (PNP) would be to identify specific sensory…
Leveraging Historical Data For High-dimensional Covariate-adaptive Randomization, A Machine Learning Approach.
There is a continuous growth in data collected in clinical trials. Many of those patient’s characteristics are potential…
Correcting For The Individual Patient Regression To The Mean Effect
Often, the primary endpoint of RCTs is defined as a change from baseline of a continuous outcome. In…
Interview on The Bio Report Podcast
Erica Smith, VP of Business Development, speaks with Daniel Levin of The Bio Report Podcast about the Placebell©™ method to reduce the impact of the placeb response in drug development”.
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