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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…
Data Integrity in GCP environment
As clinical trials become more complex, are conducted at more sites with multiple vendors (clinical sites, CROs, e-PRO, data management vendors, etc.), properly protecting data integrity becomes…
The Placebo response in drug development. Part 1: Rheumatoid Arthritis
Evidence has accumulated in recent years that the placebo response is a significant issue in evaluating efficacy of drugs for rheumatoid arthritis (RA). RA is a chronic…
The Opioid Crisis in the US: Fueling the Next Wave of Drug Development for Chronic Pain
While the opioid crisis may be creating opportunity for development of novel therapies to treat chronic pain, drug development in this area has historically struggled. According to…
Tools4Patient: Starting a new year with 20/20 hindsight
As 2019 came to a close and we begin a new decade, it’s an excellent opportunity to evaluate and learn from the past year and set a…
Modelling of PNP and OA Placebo Response: Working towards a unique model of the placebo response in chronic pain?
In analgesia randomized clinical trials (RCTs), the magnitude and the variability of the placebo response negatively impacts the…
Characterizing Personality Traits Related to the Placebo Response Using the MPsQ Questionnaire
Learn more about the development of the MPsQ and the its use as part of the Placebell©™ technology.
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