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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…
Patients are people: a new take on patient-centricity
If you ask a dozen people in the pharmaceutical / biotech industry what the term “patient-centricity” means, you’re likely to get a dozen different answers. These may include…
Predicting the placebo response in quality of life, sleep and fatigue
While significant placebo responses rates are often noted in clinical trials for indications like pain and depression, this issue can plague drug development in any therapeutic area…
Leveraging historical data to optimize the number of covariates and their explained variance in the analysis of randomized clinical trials
The amount of data collected from patients involved in clinical trials is continuously growing. All baseline patient characteristics…
Should strong placebo responders be excluded from clinical trials?
Using Predictive Modeling to understand the impact on assay sensitivity The placebo response is a heavily studied and historically challenging phenomenon for drug developers. Strong placebo effect…
Impact of excluding highly variable pain subjects on the treatment estimation
The baseline pain variability (BPV) has often been presented as positively correlating with the placebo response (PR) and…
Leveraging historical data for covariate adjustment in the analysis of randomized clinical trials
Scientific Poster presented on October 2021 at the Annual Meeting of the Royal Statistical Society of Belgium. The amount…
Understand patient differences in your next clinical trial
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