ePRO Advantages

There are proven advantages to capturing real-time Patient Reported Outcomes (PRO) data electronically. In addition to capturing significantly more reliable data, clinical trial sponsors benefit from cost and time savings when using ePRO in their clinical research.

The following list includes related articles and additional information about the advantages of ePRO in clinical research:

• Read “ePRO:  Electronic Solutions for Patient-Reported Data“;
  Edited by Bill Byrom and Brian Tiplady, Gower Publishing, 2010.
  Summary:  Recently, there has been much open debate with regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community.  In this, the industry’s first textbook dedicated solely to ePRO, Bill Byrom and Brian Tiplady address all these issues, review  the new FDA guidance on PROs in Clinical Research, and provide a very contemporary view on this important subject.

Download a sample chapter, “Diary Design Considerations: Interface Issues and Patient Acceptability” (registration required) or order the text directly through the publisher.

• Read “Measurement is Strategic” (registration required); Paty, J., Applied Clinical Trials, October 2010
  Summary:In this article, PRO Consulting Chief Scientist and Regulatory Advisor, Dr. Jean Paty poses the question, “When should researchers think about how to best measure their products’ efficacy?” and provides a framework for ensuring that all PRO instrumentsused to evaluate a product’s efficacy and support its registration and labeling are “fit for purpose”.

• Read “Increasing Study Sensitivity Early in Trials”; Applied Clinical Trials, April 2010; Shiffman, S.
  Summary: This peer-reviewed article demonstrates why eDiaries are important in Phase II clinical trials, delivering a greater ability to detect treatment effects and reducing the size and costs of drug development programs.  Multiple case studies are presented, outlining how researchers who have adopted ePRO methods early in clinical development have gained greater insight into the full therapeutic potential of their candidate drugs.

• Read “The PROs of ePRO”; The Monitor, Feb., 2010; Waife, R. 
  Summary: In this article, industry consultant Ron Waife of Waife & Associates reviews the “pros” of ePRO in three ways:  pros, pro’s, and prose.  The article highlights of capturing PRO data electronically, how professional ePRO providers deliver value, and the need for more information about when and how ePRO should be added to the clinical development program.

• Read “Delivering on the eDiary Promise”; Shiffman, S., Applied Clinical Trials, 2005
  Summary:This article reviews how well designed electronic diary systems can improve the efficiency and quality of clinical trials and ultimately play a significant role in the FDA’s Critical Path Initiative, which represents FDA’s interest to more quickly bring safe & effective medicines to the American public.

• Read “Proving the eDiary Dividend”; McKenzie, S., Paty, J., Grogan, D., Rosano, M., Curry, L., Sciarappa, Hufford, M., Applied Clinical Trials, 2004
  Summary:This article reviews the tangible value Sepracor Pharmaceuticals realized by capturing real-time PRO data with invivodata’s eDiary system in a Phase III clinical trial. The authors demonstrate how increasing patient compliance reduced error variance, which increased the trial’s sensitivity and provided a more reliable measurement of the drug’s effectiveness.

• Read “Electronic Diaries: Applications and What Works in the Field”; Hufford, M., Shields, A., Applied Clinical Trials, 2002
  Summary: This literature review reveals that better subject compliance and more accurate field data can result from providing subjects with electronic rather than paper diaries.

• Read “Patient Non-Compliance with Paper Diaries”; Stone, A., Shiffman, S., Shwartz, J., Broderick, J., Hufford, M, British Medical Journal, 2002
  Summary:This review of diary methods compares subject compliance with paper vs. electronic diaries, demonstrating that a significant majority of paper diary entries were back-filled and dependent upon subject recall. It concludes that high levels of subject compliance can be achieved with electronic diaries, resulting in the significant majority of data being captured in real-time.

• Read “Placebo Effects, Memory, and the Value of Real Time Data in Drug Development”; Hufford, M., Applied Clinical Trials, 2002
  Summary:This article reviews how real-time data collection using electronic diaries helps avoid the memory biases partially responsible for placebo effects.

• Read “Paper vs. Electronic Diaries: Compliance and Subject Evaluations”; Hufford, M., Stone, A., Shiffman, S., Schwartz, J., Broderick, J., Applied Clinical Trials, 2002
  Summary: This review of diary methods compares patient compliance with paper vs. electronic diaries and examines subjects’ evaluation of both methods. In the study cited, subjects using electronic diaries rated them as just as easy to use, read, and carry with them as the paper diaries.

• Read “Correspondence Between Paper and Electronic Visual Analog Scales in Adult Asthmatics”; Hufford, M., Shiffman, S., White Paper, 2001
  Summary:The Visual Analog Scale (VAS) is a widely used assessment format that allows patients to rate a variety of subjective symptoms on a continuous scale. This validation study sought to examine the correspondence between paper and electronic versions of the same 3-item VAS, and confirmed that subjects rate their experience similarly regardless of whether the assessments are represented on paper or on a handheld electronic diary.