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

Predicting the Placebo response in OA to Improve the Precision of the Treatment Effect Estimation

April 30, 2021

Scientific Poster presented on April 2021 at the Osteoarthritis Research Society International Meeting. Purpose In osteoarthritis (OA) randomized clinical trials (RCTs), the magnitude and the variability of the placebo response have a negative influence when testing the statistical superiority of active compounds compared to placebo. Furthermore, the magnitude of this effect has tended to increase

Type: Scientific Poster

Authors: Samuel Branders1; Jamie Dananberg2; Frederic Clermont1; Ben Xie2; Benjamin Hsu2; J. Visich2; Akbar Khan2; Lauren Masaki2; Alvaro Pereira1 1-Tools4Patient, Mont-Saint-Guibert, Belgium 2-Unity Biotechnology, Inc., South San Francisco, CA

Date: April 29, 2021

Conference: Osteoarthritis Research Society International (OARSI)

Can Daily Self-Assessment Induce A Learning Effect Mitigating Pain Evaluation Error In Randomized Clinical Trials?

April 30, 2021

Scientific Poster presented on April 2021 at the Osteoarthritis Research Society International Meeting. Purpose Questionnaires assessing  patients’ pain level represent the majority of  efficacy endpoints in osteoarthritis (OA) randomized clinical trials (RCTs).  The intrinsic subjectivity of pain may render the evaluation of these questionnaires difficult. In turn, this could explain the high variability observed in the treatment response

Type: Scientific Poster

Authors: Arthur Ooghe, M.E.; Samuel Branders, Ph.D.; Alvaro Pereira, Ph.D.

Date: April 29, 2021

Conference: Osteoarthritis Research Society International (OARSI)

Modelling of PNP and OA Placebo Response: Working towards a unique model of the placebo response in chronic pain?

January 20, 2020

In analgesia randomized clinical trials (RCTs), the magnitude and the variability of the placebo response negatively impacts the ability to demonstrate superiority of active compounds compared to placebo. The first objective of this analysis was to investigate parameters influencing the placebo response in PNP as a way to control for this major confounding factor.

Type: Scientific Poster

Authors: Samuel Branders, PhD ; Alvaro Pereira, PhD ; Erica Smith, PhD ; Dominique Demolle, PhD.

Date: February 1, 2020

Conference: CNS Clinical Trials and Methodology (ISCTM)