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Insights

Embracing Human Complexity in Clinical Research

As clinical trials become more diverse, patient heterogeneity, placebo responses, and inter-site variability become more pronounced, contributing to high rates of failed trials and extended development timelines…

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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…

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Education

Understanding the Placebo Effect: Increasing Clinical Trial Success

Placebos are used in randomized, placebo-controlled controlled trials, in which one group (or more) receives the active treatment and the other group receives the placebo control. This…

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Insights

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…

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Insights

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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Insights

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…

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Insights

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…

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Understand patient differences in your next clinical trial

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