Scientific Presentation made on September 2019 at the European Pain Federation (EFIC), Valencia, Spain. One way to better personalized the treatment of peripheral neuropathic pain (PNP) would be to identify specific sensory phenotypes of patients responding to different classes of drugs. Recent results have suggested that quantitative sensory testing (QST) could be useful, but these
here is a continuous growth in data collected in clinical trials. Many of those patient’s characteristics are potential confounding factors. Ideally, these factors should be accounted for in the randomization process to balance study arms and reduce the variability of the estimated treatment effect.
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.
Technology Presentation made on March 2019 at the Patient Partnering in Clinical Development Conference, Berlin, Germany. 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
Scientific Presentation made on June 2018 at the Promoting Statistical Insight Conference, London, United-Kingdom. 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
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.
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
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.
In analgesia randomized clinical trials (RCTs), the magnitude of the placebo response tends to increase with the year of trial completion, including in neuropathic pain trials.
This proof-of-concept study on peripheral neuropathic pain patients investigates the potential influence
of the investigator on the placebo response in RCTs while manipulating different variables, including
patient expectation, conditioning and prior experiences, observational and social learning.