Leveraging historical data to optimize the number of covariates and their explained variance in the analysis of randomized clinical trials

January 11, 2022

The amount of data collected from patients involved in clinical trials is continuously growing. All baseline patient characteristics are potential covariates that could be used to improve clinical trial analysis and power. However, the limited number of patients in phases I and II studies restricts the possible number of covariates included in the analyses. In

Type: Scientific Publication

Authors: Samuel Branders, Alvaro Pereira, Guillaume Bernard, Marie Ernst, Jamie Danenberg, Adelin Albert

Date: December 13, 2021

Conference: Statistical Methods in Medical Research Journal

Impact of excluding highly variable pain subjects on the treatment estimation

November 8, 2021

The baseline pain variability (BPV) has often been presented as positively correlating with the placebo response (PR) and associated with a lack of consistency in the subjects’ pain evaluation. Excluding high BPV subjects should then improve the precision of the treatment response. Another common method to increase the essay sensitivity is to adjust the analysis for covariates

Type: Scientific Poster

Authors: Arthur Ooghe, Samuel Branders, Alvaro Pereira

Date: November 8, 2021

Conference: CNS Summit

Leveraging historical data for covariate adjustment in the analysis of randomized clinical trials

October 26, 2021

Scientific Poster presented on October 2021 at the Annual Meeting of the Royal Statistical Society of Belgium. The amount of data collected from patients involved in clinical trials is continuouslygrowing. All baseline patient characteristics are potential covariates that could be used to improve clinical trial analysis and power. However, the limited number of patients in phases

Type: Scientific Poster

Authors: Samuel Branders, Alvaro Pereira, Guillaume Bernard,Marie Ernst, Adelin Albert

Date: October 21, 2021

Conference: Royal Statistical Society of Belgium

Should placebo responders be excluded from RCTs?

September 30, 2021

Scientific Poster presented on September 2021 at the International Society for CNS Clinical Trial and Methodology Conference The Methodological Question Being Addressed  Recently, several models predictive of the placebo response in pain RCTs have been published. The most obvious application of these models is the identification and exclusion of placebo responders before randomization in an enriched screening procedure. We investigated the benefit

Type: Scientific Poster

Authors: Branders S., Pereira A., Demolle D.

Date: October 1, 2021

Conference: ISCTM Autumn Conference

Modeling of the Placebo Response in Parkinson’s Disease

September 16, 2021

The magnitude and the variability of the placebo response have a confounding influence when testing the superiority of active compounds compared to placebo. Identifying covariates associated with this PD placebo response may help mitigate its effect, increase the study power, and result in more optimal RCT design in future studies. 

Type: Scientific Poster

Authors: Branders S., Rascol O., Garraux G., Berman B., Stebbins G., Goetz C., Billocq C., Pereira A.

Date: September 17, 2021

Conference: International Parkinson and Movement Disorder Society

Towards an automated rating of the MDS-UPDRS motor scores

September 16, 2021

Tools4Patient has developed an IMU-based device where sensors are placed on the tip of the index finger and thumb bilaterally. The device was used in a PD study to record movements during 4 motor tasks of the MDS-UPDRS Part III: finger tapping (FT), pronation/supination of hands (PSH), postural tremor of the hands (PTH) and kinetic tremor of the hands (KTH). This pilot study including 14 PD subjects was single-site, non-randomized, observational with no treatment intervention.

Type: Scientific Poster

Authors: Marchal S., Garraux G., Branders S., Bernard G., Billocq C., Pereira A.

Date: September 17, 2021

Conference: International Parkinson and Movement Disorder Society