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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…
Top 3 Risks of Unchecked Placebo Response in Clinical Trials
Placebo response is one of the biggest threats to clinical data analysis– especially when left unchecked. In this blog, we review the top three risks trial scientists must address (and how to address them).
How to Use ePRO to Understand the Impact of Decentralized Clinical Trials on Patients
In this article, we will first discuss the rise of DCTs, empowered by technology like ePRO in clinical trials. Then, we will review how related technology can…
Should placebo responders be excluded from RCTs?
Scientific Poster presented on September 2021 at the International Society for CNS Clinical Trial and Methodology Conference The…
Getting New Pain Drugs to Market: 3 Challenges
Each September, pain advocates and specialists raise awareness about issues facing the millions of people living with chronic pain. One of the most pressing? The lack of treatments available to alleviate suffering.…
How much of the measured treatment response in clinical trials is due to the placebo response?
Clinical trials measure efficacy of experimental therapies by comparing outcomes in patients receiving therapeutic interventions (treatment response) with patients receiving placebo (placebo response).
Video Presentation – Towards an automated rating of the MDS-UPDRS motor scores
Scientific poster presented on September 2021 at the International Parkinson and Movement Disorder Society Annual Conference.
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