Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge

NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge

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Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge

The report is built using information from primary and secondary research including interview with experts in the field.

GBI Research analysis shows that regulators and reimbursement authorities are driving efforts to involve patients in drug development through initiating projects to find out what matters most to patients and including this in their own benefit-risk or value assessments. Pharmaceutical companies will need to take this changing environment into consideration more carefully when designing strategies across the board, as well as in defining the particulars of individual development programs and clinical trials. Company strategies should depend on identifying key areas of unmet need as patients in these areas may be willing to take more risks and reimbursement authorities will be more willing to finance new, and potentially expensive, treatments for drugs in these areas.

- Definitions and regulatory status of Patient-Reported Outcome measures and electronic Patient-Reported Outcome measures.

- Detailed analysis of Patient-Reported Outcome instrument development and collaborations underway to accelerate their development in key therapeutic areas.

- Analysis of patient relevance in the assessment of a new drug's value by health technology assessors and reimbursement authorities.

- Growth of online communities of patients with particular diseases and their relevance in drug development.

- Identify key projects that are developing methods for involving patients more closely in decision making and agenda setting activities.

- Develop strategies for Patient-Reported Outcome instrument development.

- Understand the current thinking amongst regulators and reimbursement authorities with regards to Patient-Reported Outcome measures.

- Explore ways in which to interact with patients online or to use information generated by online communities to support new research strategies.

1 Table of Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 72 Introduction 83 Patient Perspectives – Regulatory Focus 93.1 The US FDA 93.2 European Medicines Agency 103.3 Patient Perspectives – Reimbursement Focus 113.4 Patients and the Pharmaceutical Industry 123.4.1 The EU Patient Partnership Project 123.4.2 The Drug Information Association (DIA) Patient Fellowship Program 143.4.3 The James Lind Alliance 143.4.4 Engaging the Pharmaceutical Industry 153.5 Overcoming Barriers to Patient Involvement 164 Patient Reported Outcomes 174.1 Introduction 174.2 Regulatory Guidance 184.2.1 FDA Guidance 184.2.2 EMA Reflection Paper 184.2.3 Influence of EMA and FDA Guidance Documents 194.3 Using PROs in drug development 204.3.1 PRO Instrument Development and the FDA 214.3.2 Contract Research Organisations with PRO Expertise 214.3.3 PRO Instruments: Sharing and Cooperation 224.3.4 Electronic PRO instruments 244.4 Conclusions 255 Ensuring Patient Relevance in Value Assessments 265.1 Introduction 265.2 Patient Preference Data in Quantifying Benefit-Risk Decisions 265.3 Patient-preference Data in Reimbursement Decision-making 285.3.1 Quality Adjusted Life Years and HRQL Data 285.3.2 Patient involvement with NICE 305.3.3 Patient Preference Methods 315.3.4 Conjoint analysis 325.3.5 Qualitative Studies of Patient Preference 335.4 Patient Perspectives and Comparative Effectiveness Research in the US 335.4.1 The US Patient Centered Outcomes Research Institute (PCORI) 335.5 Conclusions 356 Patients Online 366.1 Introduction 366.2 Tracking, Monitoring and Sharing Data 366.2.1 Quantified Self 376.2.2 wikiLife 376.3 E-communities 386.3.1 PatientsLikeMe.com 386.3.2 CureTogether.com 396.4 Patients, Social Media and Personalized Medicine 396.5 Conclusions 406.6 Future Outlook 407 Appendix 417.1 Key Definitions 417.2 Abbreviations (in alphabetical order) 417.3 References (in alphabetical order) 427.4 Methodology 447.4.1 Primary Research 457.4.2 Secondary Research 457.5 Contacts Us 457.6 Disclaimer 46

List of Tables

1.1 List of TablesTable 1: Patient Perspectives, Role of Patient-reported Outcomes and Health-related Quality of Life Data in Product Labelling in the US and EU, 2006-2010 19Table 2: Patient Perspectives, Examples of Contract Research Organizations with Expertise in Patient-Reported Outcomes 21Table 3: Patient Perspectives, Potential Benefits of ePRO Solutions 24

List of Figures

1.2 List of FiguresFigure 1: Patient Perspectives, Patients' and Consumers' Organizations Working with the EMA 11Figure 2: Patient Perspectives, Potential Barriers Towards Patient Involvement: Results of the Patient Partner Project Survey 13Figure 3: Patient Perspectives, Schizophrenia Research Priorities Identified through the James Lind Alliance 15Figure 4: Patient Perspectives, Examples of Disease Areas and Relevant Primary Endpoints 17Figure 5: Patient Perspectives, Process for Including Patient Reported Outcome Measures in Drug Development 20Figure 6: Patient Perspectives, Pharmaceutical Companies Working Together for Patient-Reported Outcome Instrument Development in the Critical Path Institute's PRO Consortium 22Figure 7: Patient Perspectives, The Process Used By The Critical Path Institute's PRO Consortium for PRO Instrument Development 23Figure 8: Patient Perspectives, History of Regulatory Actions on Quantitative Benefit-Risk Analysis 26Figure 9: Patient Perspectives, Schematic of the BRAT Framework,2011 27Figure 10: Patient Perspectives, Steps in the BRAT Framework, 2011 27Figure 11: Patient Perspectives, Quality Adjusted Life Years in Practice, 2009 28Figure 12: Patient Perspectives, Difference in Focus for HRQL and Patient Pereference Methods for Determining Value, 2007 31Figure 13: Patient Perspectives, PatientsLikeMe.com 38

To order this report:Drug Discovery and Development Industry: Patient Perspectives - Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge

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