Insights
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.
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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 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.
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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 variability in clinical trial data. An imbalance in these factors between treatment groups at baseline will increase variability of the estimated treatment effect, ultimately compromising study power and decreasing
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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 or may not relate to treatment response. For example, patient age may be used as a baseline covariate to reduce data variability resulting from this factor. The use of baseline
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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 initiated as of 21 September 2020 (GlobalData). The success of these studies, however, may be at risk due to an invisible threat – the placebo response.
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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 may improve interpretation of clinical trial results. During the webinar, questions from the audience were addressed; the main ones are compiled below.
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