Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 5 | 3 |
| List of Tables | 7 | 1 |
| List of Figures | 7 | 1 |
| Introduction | 8 | 1 |
| Patient Perspectives Regulatory Focus | 9 | 8 |
| The US FDA | 9 | 1 |
| European Medicines Agency | 10 | 1 |
| Patient Perspectives Reimbursement Focus | 11 | 1 |
| Patients and the Pharmaceutical Industry | 12 | 1 |
| The EU Patient Partnership Project | 12 | 2 |
| The Drug Information Association (DIA) Patient Fellowship Program | 14 | 1 |
| The James Lind Alliance | 14 | 1 |
| Engaging the Pharmaceutical Industry | 15 | 1 |
| Overcoming Barriers to Patient Involvement | 16 | 1 |
| Patient Reported Outcomes | 17 | 9 |
| Introduction | 17 | 1 |
| Regulatory Guidance | 18 | 1 |
| FDA Guidance | 18 | 1 |
| EMA Reflection Paper | 18 | 1 |
| Influence of EMA and FDA Guidance Documents | 19 | 1 |
| Using PROs in drug development | 20 | 1 |
| PRO Instrument Development and the FDA | 21 | 1 |
| Contract Research Organisations with PRO Expertise | 21 | 1 |
| PRO Instruments: Sharing and Cooperation | 22 | 2 |
| Electronic PRO instruments | 24 | 1 |
| Conclusions | 25 | 1 |
| Ensuring Patient Relevance in Value Assessments | 26 | 10 |
| Introduction | 26 | 1 |
| Patient Preference Data in Quantifying Benefit-Risk Decisions | 26 | 2 |
| Patient-preference Data in Reimbursement Decision-making | 28 | 1 |
| Quality Adjusted Life Years and HRQL Data | 28 | 2 |
| Patient involvement with NICE | 30 | 1 |
| Patient Preference Methods | 31 | 1 |
| Conjoint analysis | 32 | 1 |
| Value Perceptions in Germany | 32 | 1 |
| Qualitative Studies of Patient Preference | 33 | 1 |
| Patient Perspectives and Comparative Effectiveness Research in the US | 33 | 1 |
| The US Patient Centered Outcomes Research Institute (PCORI) | 33 | 1 |
| Relevance of PCORI for Advancing Patient Perspectives in Drug Development | 34 | 1 |
| Conclusions | 35 | 1 |
| Patients Online | 36 | 5 |
| Introduction | 36 | 1 |
| Tracking, Monitoring and Sharing Data | 36 | 1 |
| Quantified Self | 37 | 1 |
| wikiLife | 37 | 1 |
| E-communities | 38 | 1 |
| PatientsLikeMe.com | 38 | 1 |
| CureTogether.com | 39 | 1 |
| Patients, Social Media and Personalized Medicine | 39 | 1 |
| Conclusions | 40 | 1 |
| Future Outlook | 40 | 1 |
| Appendix | 41 | 6 |
| Key Definitions | 41 | 1 |
| Abbreviations (in alphabetical order) | 41 | 1 |
| References (in alphabetical order) | 42 | 2 |
| Methodology | 44 | 2 |
| Primary Research | 45 | 1 |
| Secondary Research | 45 | 1 |
| Contacts Us | 45 | 1 |
| Disclaimer | 46 | 1 |
