Publications

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)

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

August 18, 2019

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)

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

August 7, 2019

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

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Correcting For The Individual Patient Regression To The Mean Effect

August 7, 2019

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

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Putting Patient Uniqueness at the heart of Innovation

March 6, 2019

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

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

June 6, 2018

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

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