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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…
How to Increase Clinical Study Power with Covariate Adjustment
Adjustment for covariates helps clinical trial statisticians demonstrate differences in drug effect between groups of people. In this blog, we discuss what this means and how it…
Minimizing Evaluation Error in Osteoarthritis Pain
Osteoarthritis trials have relatively a rate of failure due to many factors, including disease heterogeneity, a disconnect between pain improvement and structural improvement, a strong placebo response,…
Predicting the placebo response in OA to improve the precision of the treatment effect estimation
The current abstract is the result of a collaboration between Unity biotechnology and Tools4 patient As you know, the placebo response is one of the major sources of variability in randomized clinical trials As a result, many trials fail due to a high placebo response. Unfortunately, this is also true in OA studies. However, within Tools4Patient, we have developed…
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…
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