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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…
Regulatory Guidelines for the Use of Baseline Covariates to Increase Clinical Trial Study Power
Clinical trials data analyses can employ baseline covariates to control for factors that may impact measurement of outcomes – particularly to describe individual patient characteristics that may…
Does the placebo response need to be considered in clinical trials for COVID-19 vaccines and treatments?
The search for drugs to treat and prevent SARS-CoV-2 infection is ongoing, with more than 1200 drugs in the pipeline and more 3,200 clinical trials planned or…
Frequently asked questions about COV-IQ
This webinar aimed to explain the impact of COVID-19 crisis on patient behavior in ongoing clinical trials, introduce the application of COV-IQ technology and describe how it…
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