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ePRO Resource Center

Overview of Patient Reported Outcomes (PRO)

• Read “Measurement is Strategic”; Paty, J., Applied Clinical Trials, October 2010
• Read “Two Decades of Change for PROs: How patient-reported data collection has been transformed since 1987“; Shiffman, S., Applied Clinical Trials, 2008
• Read “The Past, Present, and Future of Capturing Subject’s Experience in Clinical Trials”; Paty, J., Engfer, D., Good Clinical Practice Journal, 2003
• Read “Methodological Issues Affecting the Value of Patient Reported Outcomes Data”; Hufford, M., Shiffman, S., Expert Rev. Pharmacoeconomics Outcomes Res., 2002
• Read “Subject Experience Diaries in Clinical Research Parts I & II”; Shiffman, S., Hufford, M., Paty, J., Applied Clinical Trials, 2001

FDA Guidance on PRO

• Download the FDA’s PRO Guidance
• Webinar Replay: Clinical Outcome Assessments – Review of FDA Workshop and Implications to New Drug Development, November 2011
• Webinar Replay: Interpreting Regulatory Feedback on PRO Instruments – Now what?, Dr. Jean Paty & Katarina Halling, June 2011
• Webinar Replay: Is Your PRO Instrument Ready for Regulatory Evaluation?, Dr. Jean Paty, May 2011
• Read “The Patient Matters: Thanks FDA”. Paty, J., February 2011 
• White Paper: “ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes“, Craig, G., September 2010
• Webinar Replay: “Implementing PROs in Clinical Trials“, Dr. Jean Paty, April 2010
• Webinar Replay: “How to Effectively Incorporate PROs into Clinical Trials“, Dr. Jean Paty, March 2010
• Webinar Replay: ”Final PRO Guidance Insight from invivodata“, Dr. Jean Paty, January 2010
• Read, “Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report“; Coons, S., Gwaltney, C., Hays, R., Lundy, J., Sloan, J., Revicki, D., Lenderking, W., Cella, D., Basch, E., on behalf of the ISPOR ePRO Task Force, Value in Health, Novemeber, 2009
• Read, “Evaluating & Documenting Content Validity for the Use of Existing PRO Instruments & Their Modification“; Rothman, M., Burke, L., Pennifer, E., Kline-Leidy, N., Patrick, D.L., Petrie, C.D., on behalf of the ISPOR ePRO Task Force, Value in Health, November, 2009
• Read, “Translation & Linguistic Validation of PRO Instruments”; Wilde, D., Eremenco, S., Mear, I., Martin, M., Houchin, C., Gawlicki, M., Hareendran, A., Wiklund, I., Chong, L., Von Maltzahn, R., Cohen, L., Molsen, E., ., on behalf of the ISPOR ePRO Task Force, Value in Health, November, 2009
• Download, “Answering Questions about FDA’s Draft Guidance on Patient Reported Outcomes (PROs)“; Gwaltney, C., December, 2008
• Read, “Patient-Reported Outcomes to Support Medical Product labeling Claims: FDA Perspective”; Sloan, J., Halyard, M., Frost, M., Dueck, A., Teschendorf, B., Rothman, M, the Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group (Online Article – Blackwell Synergy Download Fee Applies)
• Read “Equivalence of Electronic and Paper-and-Pencil Administration of Patient-Reported Outcome Measures: A Meta-Analytic Review”; Shields, A., Gwaltney, C., Shiffman, S., Value in Health, September 2007 (Online Early Article – Blackwell Synergy Download Fee Applies)
• Read “Grasping the FDA’s PRO Guidance”; Shields, A., Gwaltney, C., Tiplady, B, Paty, J., Shiffman, S. Applied Clinical Trials, 2006
• Read “Documentation of PRO Instruments to Meet Contemporary FDA Standards”; Shields, A., Gwaltney, C., Paty, J., Shiffman, S., White Paper, 2006
• Read “Conceptualizing Modifications & Identifying Validation Procedures for PRO Instruments”; Shields, A., Gwaltney, C., Paty, J., Shiffman, S., White Paper, 2006
• Read: “Distinguishing among Symptom vs. Health Related Quality of Life PRO Concepts: Developing a Conceptual Framework”; Shields, A., Gwaltney, C., Paty, J., Shiffman, S., White Paper, 2006
• Read “Equivalence of Computerized and Paper and Pencil PRO Measures White Paper”; Gwaltney, C., Shields, A., Shiffman, S., White Paper, 2006
• View Webinar Replay: Migration of PRO Measures from Paper to Electronic: Theoretical & Practical Perspectives
• View Webinar: Practical Implications of the FDA’s Draft Guidance

ePRO Advantages

• Webinar Replay “Are eDiaries Really Better Than Paper?”, December 2011
• Read “Measurement is Strategic“; Paty, J., Applied Clinical Trials, October 2010
• Read “Increasing Study Sensitivity Early in Trials”; Applied Clinical Trials, April 2010; Shiffman, S.
• Read “Delivering on the eDiary Promise”; Shiffman, S., Applied Clinical Trials, 2005
• Read “Proving the eDiary Dividend”; McKenzie, S., Paty, J., Grogan, D., Rosano, M., Curry, L., Sciarappa, Hufford, M., Applied Clinical Trials, 2004
• Read “Electronic Diaries: Applications and What Works in the Field”; Hufford, M., Shields, A., Applied Clinical Trials, 2002
• Read “Patient Non-Compliance with Paper Diaries”; Stone, A., Shiffman, S., Shwartz, J., Broderick, J., Hufford, M, British Medical Journal, 2002
• Read “Placebo Effects, Memory, and the Value of Real Time Data in Drug Development”; Hufford, M., Applied Clinical Trials, 2002
• Read “Paper vs. Electronic Diaries: Compliance and Subject Evaluations”; Hufford, M., Stone, A., Shiffman, S., Schwartz, J., Broderick, J., Applied Clinical Trials, 2002
• Read “Correspondence Between Paper and Electronic Visual Analog Scales in Adult Asthmatics”; Hufford, M., Shiffman, S., White Paper, 2000

ePRO Technology Options

• Read “Electronic Patient Reported Outcomes (ePRO): Focus on Site-Based Assessments“, Tiplady, B., October 2010
• Read “PDA or IVR-based Patient-Reported Outcomes Systems:  Criteria to be considered when selecting an electronic PRO technology”; Pierce, J., Tiplady, B., 2009
• Read  “Ahead of the ePRO Curve”; Applied Clinical Trials, Jan. 21, 2010
• Read, “ePROs:  Practical Issues in Pen and Touchscreen Systems”; Tiplady, G., Applied Clinical Trials, 2007
• Read, “ePRO and EDC:  Perfect Together”; McClelland, J., and Newbigging, A., Applied Clinical Trials, 2008
• Read, “Assessment of pain: a community-based diary survey in the USA”; Krueger, A., Stone, A.; The Lancet, 2008
• 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
• 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
• Read “Developing and Validating Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
• Read “Assessment of post-surgical recovery after discharge using a pen computer diary”; Begg, A., Drummond, G., Tiplady, B., Anaesthesia, 2003
• Read “The Role of the Clinical Protocol in Developing and Implementing Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
• Read “What is a Subject Diary and What Regulations Apply”; Stokes, T., Paty, J., Applied Clinical Trials, 2002
• Read “Collecting Reliable Real-Time Patient Experience Data”; Stokes, T., Paty, J., Hufford, M., Drug Information Journal, 2001
• Download, “DiaryPRO® Datasheet“
• Download, “SitePRO® Datasheet“
• Download, “EPX™ePRO Management System Datasheet“

ePRO Resource Center / Global Clinical Trial Regulations

• Read “The Patient Matters: Thanks FDA”. Paty, J., February 2011 
• White Paper: “ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes“, Craig, G., September 2010
• Download the “European Medicines Agency’s (EMEA) Reflection Paper on the Regulatory Guidance for the use of Health Related Quality of Life (HRQOL) Measure in the Evaluation of Medicinal Products“
• Read “Global Trials Draw Regulatory Scrutiny”, Wechsler, J., Applied Clinical Trials, Sep., 2008
• Read “Create a Successful Project Plan for Global Trials,” Glancszpigel, D.,  Rácaro, G.,  Applied Clinical Trials, Nov., 2007
• Read “Global Clinical Trials Activity in the Details,”  Getz, K., Applied Clinical Trials, Sep., 2007

ePRO Benefits in Select Therapeutic Areas

• Read Case studies of approved New Drug Applications (NDAs) in Allergy, Irritable Bowel Syndrome, Pain, and Diabetes that involved the capture of Patient Reported Outcomes (PRO) data with invivodata’s ePRO solutions, July 2009
• Read “Fibromyalgia Trials Successfully Measure Subjects’ Pain”; Gendreau, M., Gendreau, J., Navis, B.D., Gwaltney, C., Paty, J., BioExecutive International, 2007
• Read “Proving the eDiary Dividend”; McKenzie, S., Paty, J., Grogan, D., Rosano, M., Curry, L., Sciarappa, Hufford, M., Applied Clinical Trials, 2004 (overview of eDiary Application in Overactive Bladder trial)
• Read “Assessment of post-surgical recovery after discharge using a pen computer diary”; Begg, A., Drummond, G., Tiplady, B., Anaesthesia, 2003
• Read “Correspondence Between Paper and Electronic Visual Analog Scales in Adult Asthmatics”; Hufford, M., Shiffman, S., White Paper, 2001

Presentations and Podcasts

• Webinar Replay: Are eDiaries Really Better Than Paper?
• Webinar Replay: Clinical Outcome Assessments – Review of FDA Workshop and Implications to New Drug Development
• Webinar Replay: PRO Regulatory Update: Migrating Instruments from Paper to Electronic Format
• Webinar Replay: Leveraging the Internet in Clinical Research – Practical Applications & Considerations of Web-Based ePRO
• Webinar Replay: Interpreting Regulatory Feedback on PRO Instruments – Now what?
• Webinar Replay: Is Your PRO Instrument Ready for Regulatory Evaluation?
• Webinar Replay: Value of ePRO Early in Clinical Trials
• Webinar Replay: ePRO Regulatory Environment in Europe
• Webinar Replay: ePRO: Focus on Site-Based Assessments
• Webinar Replay: How do you know your drug works? Measurement is Strategic
• Webinar Replay: ePRO Regulatory Inspection Expectations – Be ready, be agile, be precise!
• Webinar Replay: Implementing PROs in Clinical Trials
• Webinar Replay: ePRO Industry Best Practice and Regulatory Considerations: An Update on Issues that Affect your Clinical Trials
• Webinar Replay: How to Effectively Incorporate PROs into Clinical Trials
• Webinar Replay: Final PRO Guidance Insight from invivodata
• Webinar Replay: Developing PROs: Common Pitfalls & Recent Experiences
• Webinar Replay: ePRO Regulatory Environment in Europe
• Webinar Replay: How Much do You Know About the FDA’s Draft PRO Guidance?
• Webinar Replay: An Integrated Approach: Combining ePRO and EDC
• Webinar Replay: Migration of PRO Measures from Paper to Electronic: Theoretical & Practical Perspectives
• Podcast: ePRO’s Impact on Clinical Trials
• Webinar Replay: Practical Implications of the FDA Draft PRO Guidance
• Webinar Replay: ePRO Regulatory Inspections

ePRO Pulse

• Fall 2011: View Fall ’11 ePRO Pulse
• Summer 2011: View Summer ’11 ePRO Pulse
• Spring 2011: View Spring ’11 ePRO Pulse
• Winter 2011: View Winter ’11 ePRO Pulse

Useful Links

• The Food and Drug Administration
• The Drug Information Association
• Clinical Data Interchange Standards Consortium