Insights
Predicting the placebo response in quality of life, sleep and fatigue
While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area – particularly in diseases that rely on subjective or patient-reported outcomes as primary efficacy endpoints. Quality of life (QoL) endpoints, for example, are often used to measure therapeutic efficacy in oncology clinical trials – but also in diseases like schizophrenia, pain, heart failure, inflammatory bowel disease (IBD), allergy and pruritus.
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
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).
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
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.
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.