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ePRO Resource Center > ePRO Technology Options

ePRO Technology Options

There are a wide variety of technologies available for sponsors who choose to capture Patient Reported Outcomes (PRO) data electronically. From handheld eDiaries to Interactive Voice Response Systems (IVRS) and other technology-enabled solutions, sponsors now have many options to select from in order to identify the ePRO method that best fits their trial needs.

Presented below are related articles and additional information about ePRO technology options.

  • Read “PDA or IVR_based Patient-Reported Outcomes Systems:  Criteria to be considered when selecting an electronic PRO technology,” Pierce, J., Tiplady, B., 2009  
    Summary:  This white paper describes an electronic patient-reported outcomes (ePRO) modality decision tool that provides a systematic, standardized framework for assessing the utility and feasibility of the two main electronic patient-reported outcomes modalities: handheld device and interactive voice response (IVR) systems. The components of this tool are based on published and unpublished research as well as the substantial experience of two ePRO market leaders and have been further validated by market research with clinical trial sponsors.
  • Read  “Ahead of the ePRO Curve"; Applied Clinical Trials 21 January 2010
    Summary:  Applied Clinical Trials editor Lisa Henderson reviews the momentum in the pharmaceutical industry toward the use of Patient Reported Outcomes data in clinical trials, including the FDA’s final publication of a Guidance to Industry on the use of PROs and Quintiles’ selection of invivodata as its primary preferred provider of ePRO solutions.  Read Ahead of the ePRO Curve now
  • Read, “Alcohol and Cognitive Function: Assessment in Everyday Life and Laboratory Settings Using Mobile Phones”; Tiplady, B., Oshinowo, B., Thompson, J., Drummond, G.B.; Alcoholism: Clinical and Experimental Research;   December, 2009
    Summary:  Mobile phone (cellphone) technology makes it practicable to assess cognitive function in a natural setting. This article assesses this method and compares impairment of performance due to alcohol in everyday life with measurements made in the laboratory.
     
  • Watch "Choosing an ePRO Modality for your Clinical Trial" Webinar; Pearce, J; Tiplady, B., August 2009
    Summary: This webinar will discuss a newly developed ePRO modality decision tool that will guide you in selecting the most appropriate ePRO system based on your study parameters. The pros and cons of the various ePRO modalities will be discussed with an emphasis on how important patient-specific factors influence responses in an electronic format.
     
  • Read, “ePRO and EDC:  Perfect Together”; McClelland, J., and Newbigging, A., Applied Clinical Trials, 2008
    Summary:  This article review the evolving role of electronic Patient Reported Outcomes (ePRO) and Electronic Data Capture (EDC) integration in clinical development, including the requirements for success, benefits, and future of ePRO/EDC integration.
     
  • Read, “Assessment of pain: a community-based diary survey in the USA”; Krueger, A., Stone, A.; The Lancet, 2008
    Summary: The researchers conducted a community-based telephone survey using the Princeton Affect and Time Survey (PATS) to assess the proportion of people experiencing pain, and the severity of pain, at randomly selected times in a representative sample of individuals in the USA. This article describes their findings which replicate previous ones, contradict some previous findings, and extend our knowledge about daily pain and activities. 
     
  • Read, “ePROs:  Practical Issues in Pen and Touchscreen Systems”; Tiplady, G., Applied Clinical Trials, 2007
    Summary:  Electronic patient reported outcomes (ePROs) are in increasing use as a tool for collecting diary and questionnaire data directly from patients.  Despite their clear advantages, concerns about the use of electronic systems have been raised in two main areas.  In this article, Dr. Tiplady discusses the practical considerations for successful ePRO data collection, including user acceptance and ensuring the equivalence of electronic versions of standardized paper methods.
     
  • Read “Electronic Diaries and Questionnaires: Designing User Interfaces that are Easy for all Patients to Use”; Palmblad, M., Tiplady, B., Quality of Life Research, 2004
    Summary: In this article, the authors propose a set of requirements for designing handheld computer systems for electronic collection of patient diary and questionnaire data in clinical trials. Guidelines are presented so bias may be avoided both in patient selection and in the responses made; so that electronic data collection may be as effective as possible, and study procedures are convenient and unobtrusive for the patients.
     
  • Read “Developing and Validating Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
    Summary: In this 3rd part of a Technology update series, the authors discuss the development and validation of an eDiary system that meets regulatory requirements based upon a clinical protocol.
     
  • Read “Assessment of post-surgical recovery after discharge using a pen computer diary”; Begg, A., Drummond, G., Tiplady, B., Anaesthesia, 2003
    Summary: Patients were assessed after their return home from gynaecological surgery using a daily pen-based electronic diary. They also completed a questionnaire at the end of the study month. The article concludes that daily electronic pen-diaries are an acceptable method of obtaining better information on the extent and duration of symptoms and other difficulties after discharge following surgery.
     
  • Read “The Role of the Clinical Protocol in Developing and Implementing Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
    Summary: This article presents the clinical, technical, and regulatory issues involved in the development and implementation of eDiary trials that meet regulatory requirements. Although clinicians have reasonable concerns about adopting technology, the authors demonstrate that the collaboration of clinical and technology teams can result in a robust clinical trial executed in a timely fashion.
     
  • Read “What is a Subject Diary and What Regulations Apply”; Stokes, T., Paty, J., Applied Clinical Trials, 2002
    Summary: In this article, the authors address the following questions about regulatory issues in subject diary research: Why are subject diaries important to clinical research? How does ICH GCP apply to subject diaries—electronic and paper? How do FDA guidance and 21 CFR 11 apply to subject diaries—electronic and paper? What are the audit and inspection criteria for subject diary data?
     
  • Read “Collecting Reliable Real-Time Patient Experience Data”; Stokes, T., Paty, J., Hufford, M., Drug Information Journal, 2001
    Summary: To succeed in a clinical trial, an electronic diary system must simultaneously meet two related standards: clinical integrity and system integrity. This article reviews the challenges and promises of such an eDiary system and highlights the importance of building a robust, subject-friendly system that can enhance subjects’ protocol compliance.
  • Download, "DiaryPRO® Data Sheet"
    Summary:  Achieve the highest levels of patient compliance and data accuracy with DiaryPRO, invivodata’s simple-to-use patient eDiary.  Available on multiple handheld devices to meet the evolving needs of global clinical trials, DiaryPRO addresses the poor reliability of paper diaries and other retrospective reporting methods by ensuring data is captured according to study protocol.  All DiaryPRO options provide the same practical, intuitive ePRO features that have been proven in hundreds of worldwide clinical trials. 
  • Download, "SitePRO® Data Sheet"
    Summary:  invivodata's in-clinic solution, SitePRO, combines the best of clinical science with mobile device and Web technology to increase efficiencies in the collection of site-based patient reported outcome (PRO) data in clinical trials.  Availalbe on multiple handheld devices, SitePRO meets clinical trial needs by automating paper-based site assessments and enabling clinical trial sponsors to manage both site and patient-based assessment data in a single source. 
  • Download, "EPX™ePRO Management System Data Sheet"
    Summary: invivodata's EPX ePRO Management System is an easy-to-use Web-based system for monitoring key areas of clinical study progress, including site and patient management, data integrity, and system functionality.  EPX creates efficiency in ePRO-related clinical trial workflows, freeing up users’ time to attend to other trial-related activities. EPX takes the worry out ePRO management for study sponsors, investigators/study coordinators and CRAs/CROs. 

 

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