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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…
Placebo Effect vs. Placebo Response: Is There A Difference?
Placebo effect and placebo response are often used interchangeably – despite being two different phenomena. In this blog, we highlight the differences—and why it matters. Placebos are an important…
Mitigating the Placebo Response in Phase II & III Clinical Trials
Phase II and III trial failure due to unexpectedly large placebo response rates is still all too common. In this blog, we explain what this means and…
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…
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…
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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