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Embracing Human Complexity in Clinical Research
As clinical trials become more diverse, patient heterogeneity, placebo responses, and inter-site variability become more pronounced, contributing to high rates of failed trials and extended development timelines…
Capturing Patients Diversity as the Next Challenge in Drug Development? Insights from IASP 2024
Earlier this month, the IASP (International Association for the Study of Pain) meeting marked a significant moment in honoring the vision of Professor John Bonica founder of…
Covariate Adjustment in Randomized Clinical Trials Based on Latest FDA Guidance: Application to Composite Covariates
In May 2023, the US Food and Drug Administration (FDA) released its final guidance titled “Adjusting for Covariates in Randomized Clinical Trials (RCT) for Drugs and Biological Products”. It is difficult to overstate the importance of this guidance as baseline covariate adjustment is an integral part of any statistical analysis of RCTs. Covariate…
How Cognivia Turns Traits Into Data with a Validated Questionnaire & Machine Learning
Learn more about the development of the MPsQ and the its use as part of the Placebell©™ technology.
Self-Training in Pain Assessment as a Mediator of the Prognostic Performance of Pain Variability
Background and Aims Baseline Pain Variability (PV) is often cited as a key predictor of placebo response (1-3)….
Pain: the Tree that Hides the Forest of Symptoms
The 2024 International Osteoarthritis Research Society (OARSI) conference concluded last week, offering valuable exchange and information. What insights could we gather from these dynamic four days? One…
MODELING THE EXPECTATIONS FOR IMPROVEMENT IN OSTEOARTHRITIS TRIALS TO ENHANCE MANAGEMENT STRATEGIES
Objective: The expectations of improvement among subjects participating in a Randomized Controlled Trials (RCT) are one of the…
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