The addition of Delphine to T4P’s expanding team reflects the company’s commitment to building and maintaining a robust quality program, which is central to its goal of being a trusted partner providing predictive tools to biopharmaceutical companies. Delphine works with T4P’s operational and scientific groups to support software and clinical-related activities for programs conducted with sponsors or as part of the company’s R&D activities.View
What if you could predict placebo responsiveness of each patient in your clinical trial? Historical strategies to address the placebo response may help but haven’t completely solved the placebo response problem. Until now. 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.View
Prediction of placebo response in Osteoarthritis improves estimation of the treatment effect: Impact on drug development
Placebell©™ can be used in OA and similar diseases in which efficacy is characterized using patient-reported outcomes to reduce the interference of the placebo effect and improve assessment of the drug effect. The performance and applicability of PlacebellI©™ has recently been demonstrated in a Phase 2 RCT conducted by a biotech sponsor in subjects with moderate to severe painful knee OA.Read More
Historically, interpretation of clinical trials relies on “assay sensitivity”, or the sensitivity to detect clinically meaningful differences between endpoints measured in the group of patients given active drug compared to the group of patients given placebo. Assay sensitivity can be influenced by many factors, including the study design, specific endpoints selected, number of clinical sites and, of course, the magnitude of the placebo response.Read More
Placebo effect and placebo response are often used interchangeably – despite being two different phenomena. In thisRead More
Phase II and III trial failure due to unexpectedly large placebo response rates is still all too common. In this blog, we explain what this means and how clinical trials can better manage the placebo response.Read More
The Psychedelic Therapeutics and Drug Development Conference has been organized to bring together the world’s leading researchers and leaders in academia and industry to discuss the challenges and opportunities facing those engagedView
Modelling of PNP and OA Placebo Response: Working towards a unique model of the placebo response in chronic pain?
In analgesia randomized clinical trials (RCTs), the magnitude and the variability of the placebo response negatively impacts the ability to demonstrate superiority of active compounds compared to placebo. The first objective of this analysis was to investigate parameters influencing the placebo response in PNP as a way to control for this major confounding factor.
Type: Scientific Poster
Date: February 2020
Conference: CNS Clinical Trials and Methodology (ISCTM)
Identification Of Peripheral Neuropathic Pain Sensory Phenotypes Based On Specific Combinations Of Symptoms Identified With The NPSI (Neuropathic Pain Symptom Inventory)
One way to better personalized the treatment of peripheral neuropathic pain (PNP) would be to identify specific sensory phenotypes of patients responding to different classes of drugs.
Type: Scientific Presentation
Date: September 2019
Conference: European Pain Federation (EFIC)
Leveraging Historical Data For High-dimensional Covariate-adaptive Randomization, A Machine Learning Approach.
There is a continuous growth in data collected in clinical trials. Many of those patient’s characteristics are potential confounding factors. Ideally, these factors should be accounted for in the randomization process to balance study arms and reduce the variability of the estimated treatment effect.
Type: Scientific Presentation
Date: June 2019
Conference: Promoting Statistical Insight Conference
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.
Date: June 2020
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”.
Date: June 2019
Learn about how Tools4Patient considers the placebo response of each individual patient in clinical trials as a central part of the Placebell© methodology.
Date: March 2019
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