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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…
Video Presentation – Can Daily Self-Assessment Induce a Learning Effect Mitigating Pain Evaluation Error in Randomized Clinical Trials?
LEARNING EFFECT & EVALUATION ERROR At Tools4Patient, we are working on the prediction of placebo response and especially the placebo response with endpoints assessing the patients’ pain. As you know, these endpoints represent most of the efficacy endpoints in Osteoarthritis Randomized Clinical Trials. Nevertheless, the assessment of…
Predicting the Placebo response in OA to Improve the Precision of the Treatment Effect Estimation
Scientific Poster presented on April 2021 at the Osteoarthritis Research Society International Meeting. Purpose In osteoarthritis (OA) randomized…
Can Daily Self-Assessment Induce A Learning Effect Mitigating Pain Evaluation Error In Randomized Clinical Trials?
Scientific Poster presented on April 2021 at the Osteoarthritis Research Society International Meeting. Purpose Questionnaires assessing patients’ pain level…
Patient Psychology: The Missing Link in Understanding Clinical Trial Data
Patients are central to clinical trials – but the impact of patient psychology on clinical trial results is still poorly understated. In this blog, we discuss why…
Placebell©™ Predicts Placebo Response in Initial Study in Parkinson’s Disease
Parkinson’s disease (PD) is one of the most common neurodegenerative disorders, as it affects 1-2 per 1000 of the population at any time(1). Although it is primarily…
Placebo Effect vs. Placebo Response: Is There A Difference?
Placebo effect and placebo response are often used interchangeably – despite being two different phenomena. In this blog, we highlight the differences—and why it matters. Placebos are an important…
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