April 30, 2021

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

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)

April 30, 2021

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

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)

January 20, 2020

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

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)

August 18, 2019

Identification Of Peripheral Neuropathic Pain Sensory Phenotypes Based On Specific Combinations Of Symptoms Identified With The NPSI (Neuropathic Pain Symptom Inventory)

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.

Type: Scientific Presentation

Authors: Didier Bouhassira(1), Samuel Banders(2), Nadine Attal(1), Dominique Demolle(2) and Alvaro Pereira(2). 1- Inserm 987, Ambroise Pare Hospital, 92100 Boulogne-Billancourt, France 2- Tools4Patient, 50 rue de Bordeaux, boîte 17, 6040 Jumet, Belgium

Date: September 1, 2019

Conference: European Pain Federation (EFIC)

August 7, 2019

Leveraging Historical Data For High-dimensional Covariate-adaptive Randomization, A Machine Learning Approach.

There 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.

Type: Scientific Presentation

Authors: Samuel Branders, PhD; Guillaume Bernard, PhD; Alvaro Pereira, PhD

Date: June 1, 2019

Conference: Promoting Statistical Insight Conference

August 7, 2019

Correcting For The Individual Patient Regression To The Mean 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.

Type: Scientific Poster

Authors: Samuel Branders, PhD; Guillaume Bernard, PhD; Alvaro Pereira, PhD

Date: March 1, 2018

Conference: American Society for Clinical Pharmacology and Therapeutics

March 6, 2019

Putting Patient Uniqueness at the heart of Innovation

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

Authors: Dominique Demolle, PhD; Stephanie Alvarez

Date: March 1, 2019

Conference: Patient Partnering in Clinical Development Conference

June 6, 2018

Leveraging historical data for high-dimensional regression adjustment, a machine learning approach.

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

Authors: Samuel Branders, PhD; Guillaume Bernard, PhD; Alvaro Pereira, PhD

Date: June 3, 2018

Conference: Promoting Statistical Insight Conference

August 7, 2017

Baseline Pain Measurements As Predictors Of The Placebo Response In Neuropathic Patients

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

Authors: Alvaro Pereira, PHD; Samuel Branders, PHD; Christian Dualé, MD PHD; Fréderic Clermont, PHD; Pierre Gramme, MS; Chantal Gossuin, PHARMD; Dominique Demolle, PHD

Date: April 1, 2017

Conference: SIPS Conference

August 7, 2017

Bayesian Modeling Of The Placebo Response In Neuropathic Pain

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

Authors: Samuel Branders, PhD; Alvaro Pereira, PhD; Frederic Clermont, PhD; Chantal Gossuin; Dominique Demolle, PhD

Date: June 1, 2017

Conference: Promoting Statistical Insight Conference