Using the Placebell Covariate to Manage Placebo Response in Clinical Trials
Erica Smith, Chief Business Officer at Cognivia, introducing Placebell©™a tool that can be used to manage the placebo response in clinical trials.
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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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Video Presentation – Modeling of the Placebo Response in Parkinson’s Disease
Scientific Poster presented on September 2021 at the International Parkinson and Movement Disorder Society Annuel Meeting.
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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 a Machine-Learning model named Placebell©™ that can overcome this placebo challenge. This machine -learning
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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 pain is, by nature, subjective and the risk is high
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Interview on The Bio Report Podcast
Erica Smith, VP of Business Development, speaks with Daniel Levin of The Bio Report Podcast about the Placebell©™ method to reduce the impact of the placeb response in drug development”.
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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 adjustment has become a standard statistical tool because of its
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Predict placebo response using patient psychology to increase trial power
Advanced methods like AI and machine learning are uniquely poised to help scientists uncover the full spectrum of patient placebo responsiveness in a clinical trial. Learn more about this approach by attending our webinar, which explains how a solution like Placebell©™ leverages a time-tested predictive algorithm to improve clinical trial assay sensitivity and de-risk drug development.
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The Impact of COVID-19 on Clinical Trial Conduct: The Importance of Considering Patient Stress, Coping and Perceptions
Learn the importance of considering patient psychological traits, expectations, perception of patient relationship with the trial physician and staff, and social structure in efforts to understand the impact of the COVID-19 pandemic on clinical trials.
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Patient-Centric Approach To Characterizing Placebo response
Learn about how Tools4Patient considers the placebo response of each individual patient in clinical trials as a central part of the Placebell© methodology.
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The Characterization of Individual Patient Placebo Response: Impact on the Clinical Study Power
Learn about the Placebell©™ method, its development in chronic pain., and how it can be easily implemented to increase study power and de-risk clinical trials.