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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…
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,…
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…
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…
The placebo response – a phenomenon related to the placebo group or to the individual patient?
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…
From covariates to confounding factors: the danger of having too many covariates
Clinical trials typically evaluate efficacy of experimental therapies in heterogeneous patient populations, as patient characteristics vary significantly. These patient characteristics might be prognostic factors that ultimately induce…
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