ERT Getting it Done. Right.

ePRO: One Size Does Not Fit All

Wilhelm Muehlhausen speaks to the importance of choice in electronic paper reported outcome solutions in clinical trials.

ePRO Solutions: How Do You Choose?

Michael Federico discusses the options for electronically collecting patient reported outcomes in clinical trials and how to choose which option is best for your patients, your study and your budget.

PharmaVoice 100 - Dr. Joel Morganroth

100 of the Most Inspiring People - Dr. Joel Morganroth featured 

Cardiac Safety: ECG Centralization

Jeffrey Litwin of ERT, Inc examines how central core labs are playing an increasingly important role in cardiac safety. 

Cardiac Safety: The Heart of the Matter

Amy Furlong at ERT examines how centralizing ECG data collection and analysis can lead to superior accuracy and reliability in cardiac safety. 

Is Centralization the Future for Cardiac Safety in Clinical Trials?

By Amy Furlong: All new pharmaceutical products must go through comprehensive testing to thoroughly assess their effect on patients before being approved for release to the market. 

Respiratory: ATS 2011 Presented Poster - Intra-visit Repeatability of Slow Spirometry

The 2005 ERS/ATS guidelines on spirometry have established a best to second best value repeatability criterion of 150 mL for VC. No criterion is given for IC. The aim of this work was to evaluate the repeatability of VC and IC in a worldwide clinical trial with COPD patients and compare with these criteria.  We used the data collected in a phase II multicenter clinical trial (TESRA, sponsored by F. Hoffmann –La Roche Ltd) to test the achievable repeatability in moderate to severe COPD patients with emphysema.  Despite the challenging patient group the test sites were able to meet the ATS/ERS repeatability criteria for VC in the majority of the tests.

Respiratory: ATS 2011 Presented Poster - Inter-visit Variability of Spirometry and Diffusion

Very good intra-visit repeatability of lung-function testing was previously shown.  However, little information is available regarding the medium term variability. The aim of this work was to evaluate the repeatability of slow and forced spirometry and diffusion parameters between run-in visits in a worldwide clinical trial with moderate to severe COPD patients.  The inter-visit variability was much bigger than the intra-visit variability, especially for the effort dependent measurements. 

Electrocardiographic Assessment for Therapeutic Proteins

In October 2010, the American Heart Journal published "Electrocardiographic Assessment for Therapeutic Proteins" regarding possible approaches to consider for the clinical evaluation of drug-induced QT prolongation in development programs of therapeutic proteins.  This white paper summarizes scientific discussions of members of the Cardiac Safety Research Consortium indcluding Dr. Jeffrey Litwin of ERT.

Ventricular Arrhythmias in Early Clinical Pharmacology Trials

In May 2010, the American Heart Journal published "Evaluation of Ventricular Arrhythmias in Early Clinical Pharmacology Trials and their Potential Consequences for Later Clinical Drug Development".  This white paper, prepared by members of the Cardiac Safety Research Consortium, including ERT's Dr. Robert Kleiman, discusses several important issues regarding the evaluation of ventricular arrhythmias in early clinical pharmacology trials and their potential consequences for later clinical drug development.

Respiratory: ERS 2010 Presented Posters

The following posters are included in this download:

Quality of forced spirometry in a worldwide multicenter clinical trial with moderate to severe COPD patients

Quality of Diffusion measurement in a multicenter clinical trial with moderate to severe COPD patients

Quality of Helium dilution lung volume measurement in a multicenter clinical trial with moderate to severe COPD patients

TUFTS Cardiac Safety Report

In February 2010, Tufts Center for the Study of Drug Development published an analysis regarding the industry adoption of Centralized Cardiac Safety and perceptions from stakeholders.

Testing the Usability of e-PRO Translations: Presented at ISPOR November 2010, Prague

In November 2010, an analysis was presented regarding the usability of ePRO translations during linguistic validation.  Specifically, the effects of cognitive interviews on an e-device vs. print out of screenshots.

eC-SSRS Suicidality Poster - Presented at the ISCTM on October 13th 2010

Electronic Administration of the Columbia-Suicide Severity Rating Scale (eC-SSRS): Results from 14,937 Administrations 

Authors: Mundt, JC; Greist, JH; Federico, M; Posner, K 

Centralized Spirometry - Why do I need to Centralize?

Prospective Assessment of Suicidality for Non-Mental Health

Live Q&A Session: Prospective Suicidality for Non-Mental Health

Cardiac Safety Assessment for New Anti-Diabetic Drugs, FDA Guidance and Overview

How do I select the Right ePRO Approach for My Patients, My Study, and My Budget?

Prospective Assessment of Suicidality - A Review and Discussion of the Recent FDA Draft Guidance

Cardiac Safety - Best Science, Best Value

Prospective Suicidality Monitoring in Clinical Trials