Often, the primary endpoint of RCTs is defined as a change from baseline of a continuous outcome. In
such cases, regulators recommend including the outcome’s baseline value as a covariate in the
statistical analysis. Regression to the mean can explain the benefits of this procedure.
Type: Scientific Poster
Date: March 1, 2018
Conference: American Society for Clinical Pharmacology and Therapeutics
Access to innovative therapies remains an issue. In certain diseases, the magnitude and variability of individuals’ placebo response (IPR) can confound detection of positive results in clinical trials. Despite the best efforts and investments by pharmaceutical industry stakeholders, patients are still waiting for optimal treatments.
Type: Technology Presentation
Date: March 1, 2019
Conference: Patient Partnering in Clinical Development Conference
The amount of data collected from patients involved in clinical trials is continuously growing. All those patient’s characteristics are potential covariates that could be used to improve study analysis and power. At the same time, the development of computerized systems simplifies the access to huge amount of historical data.
Type: Scientific Presentation
Date: June 3, 2018
Conference: Promoting Statistical Insight Conference
In analgesia randomized clinical trials (RCTs), the magnitude of the placebo response has a negative influence when testing the statistically significant superiority of active compounds compared to placebo.
Type: Scientific Poster
Date: April 1, 2017
Conference: SIPS Conference
In analgesia randomized clinical trials (RCTs), the magnitude and the variability of the placebo response have a negative influence when testing the statistically significant superiority of active compounds compared to placebo.
Type: Scientific Poster
Date: June 1, 2017
Conference: Promoting Statistical Insight Conference
The placebo response exerts a confusing influence when testing the statistically significant superiority of active compounds compared to placebo in analgesia randomized clinical trials (RCTs). Furthermore, the magnitude of this effect has tended to increase over time with the year of trial completion, including in neuropathic pain trials.
Type: Scientific Poster
Date: September 2, 2016
Conference: International Association for the Study of Pain Conference