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 2020

Conference: CNS Clinical Trials and Methodology (ISCTM)

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 2019

Conference: European Pain Federation (EFIC)

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 2019

Conference: Promoting Statistical Insight Conference

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 2018

Conference: American Society for Clinical Pharmacology and Therapeutics

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 2019

Conference: Patient Partnering in Clinical Development Conference

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 2018

Conference: Promoting Statistical Insight Conference

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 2017

Conference: SIPS Conference

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 2017

Conference: Promoting Statistical Insight Conference

Multifactorial Aspect Of The Placebo Analgesia Response In Peripheral Neuropathic Patients

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

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

Date: September 2016

Conference: International Association for the Study of Pain Conference

Characterization And Prediction Of Placebo Responders In Peripheral Neuropathic Patients In A 4-week Analgesic Clinical Trial

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.

Type: Scientific Poster

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

Date: March 2016

Conference: American Pain Society Conference