Articles & White Papers

Author: Sheila Rocchio
Published: March 2011

This article describes the web-based mode for collecting electronic patient reported outcome (ePRO). It explains which types of trials are best suited for this mode of administration, reviews psychometric validations required, and explains how and when ePRO data collected via the web can support a claim.

Author: PHT Corporation
Published: July 2010

Read the point-by-point review of the differences between the Final FDA PRO Guidance and the Draft, to review the choices made by FDA during the 3 years following the Draft PRO Guidance. These choices reveal the FDA deliberations and resulting emphasis; we suggest what some of the differences might imply. 

Author: Valdo Arnera
Published: March 2009

Every now and then, a shift in technology revolutionizes an entire industry. ePRO is the new paradigm. Learn why more companies worldwide replace paper diaries with electronic patient diaries in clinical research.

Author: Samantha Etkin
Published: November 2007

When conducting a pediatric trial, certain elements will naturally have to be tweaked and adapted to fit the needs of the young subjects involved.

Read how PHT designed appropriate eDiaries for a pediatric trial, and a suitable eCOA system for the trial subjects.

Author: PHT Corporation
Published: 2006

Read how the PHT ePRO system is ideal for vaccine trials, and how data collected are used to demonstrate safety and efficacy.

Author: S.A. Raymond, Ph.D. (PHT Corp.), E. K. Marino, Ph.D. (University of Washington)
Published: April 2005
This paper  formally compares the validity and psychophysical properties of the electronic VAS with the conventional paper VAS.

Support was found for the validity of the computer version of the VAS scale.

Author: V.Arnera PH.D. and S.A. Raymond (PHT Corp.), T.Blackadar (FitSence Technology Corp.)
Published: April 2005

This paper describes how automatic uploads from a measurement device to an electronic patient diary improve data quality in clinical research. 

Author: The Gantry Group, LLC
Published: May 2003

In this white paper, Gantry Group discusses fulfilling the promise of clinical trial diary research.

Author: PHT Corporation
Published: January 2003

This is a summary document which describes how the PHT LogPad is used to collect data from patients with pain endpoints.

Pain is a leading therapeutic area for eCOA collection. 42% of PHT Endocrinology studies collect pain as a secondary therapeutic area.

Author: Stephen A. Raymond and Gerald F. Meyer
Published: June 2002

The technology for supporting data capture and management electronically is transformational. The approach of centralizing such data without local storage should not be dismissed presumptively.

For those interested in more eSource articles, read the Insights Newsletter issue, Electronic Source (eSource) Data: Defined and Interpreted by Global Regulatory Authorities.

Author: Stephen A. Raymond and Robert N. Ross
Published: March 2000

Despite many years of experience with paper diaries in clinical studies, uncertainties persist about the timeliness, currency, completeness, and accuracy of diary data collected by conventional pencil and-paper methods.

Author: PHT Corporation

This paper outlines PHT capabilities including implementation of standard GI questionnaires on the LogPad and the ability to display graphical images such as those from the Bristol Stool Form scale.

Author: PHT Corporation

This paper describes using the PHT LogPad system to collect data for studies in the therapeutic area of the Central Nervous System. The PHT ePRO system is frequently used in registered CNS trials to collect daily diary information on outcomes such as sleep latency, cigarette cravings, mood, and agitation.

Author: Valdo Arnera

Researchers around the world understand the critical importance of the patient’s perspective in evaluating and assessing drug safety, efficacy and clinical outcomes. In the last decade, drug developers have collected patient reported outcome (PRO) data more frequently than ever before. An important goal in 2011 for sponsors across the industry is to collect higher quality PRO data in research trials.