Insights
Should strong placebo responders be excluded from clinical trials?
Using Predictive Modeling to understand the impact on assay sensitivity The placebo response is a heavily studied and historically challenging phenomenon for drug developers. Strong placebo effect diminishes the ability to distinguish efficacy of an experimental drug, leading to phase II and III trial failures1– even for otherwise effective drugs. Researchers have long devised strategies
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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).
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The Importance of Patient Psychology in Health and Clinical Research
When we think about patient characteristics that influence health, disease, and clinical research, we tend to think about things like vital statistics, medical history and genetic makeup – while patient personality or psychology is often overlooked. In reality, the importance of personality has been under scrutiny for centuries and dates back to Greek and Roman times
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The placebo response in drug development. Part 4: Irritable Bowel Disease
As in many other diseases (e.g. pain, osteoarthritis, rheumatoid arthritis, Parkinson’s Disease, etc ), patients participating in clinical trials for IBD treatments may experience a pronounced placebo effect or placebo response. As IBD is a chronic disease, efficacy is comprised of improvement rates as well as remission rates; unfortunately, both are influenced by placebo response, albeit at different rates.
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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, and high variability/inaccuracy in patient reporting of pain.
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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 a disease of the elderly, individuals have developed PD in their 30s and 40s(2). Gender differences pertaining to the incidence of PD are reflected in a 3:2 ratio of males to females, with a delayed onset in females attributed to the neuroprotective effects of estrogen on the nigrostriatal dopaminergic system(3,4).
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