GBI Research, the leading business intelligence provider, has released its latest research, Patient Perspectives Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge. The report examines the role of patients in changing the research agenda and helping pharma companies to bring effective medicines that meet real unmet medical needs into the market place. It explores the use of patient reported outcomes in drug development, with a particular focus on their use in the regulatory setting. The report investigates whether the measures used in clinical development are relevant to patients and describes current initiatives to improve patient involvement. The final chapter explores the way in which patient involvement is changing as a result of online interactions.
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.
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History of patient involvement in drug development, regulation and reimbursement.
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 drugs value by health technology assessors and reimbursement authorities.
Growth of online communities of patients with particular diseases and their relevance in drug development.
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Reasons to buy
Identify the best ways to work with patients to improve 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.
Table of Contents
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 8
3 Patient Perspectives Regulatory Focus 9
3.1 The US FDA 9
3.2 European Medicines Agency 10
3.3 Patient Perspectives Reimbursement Focus 11
3.4 Patients and the Pharmaceutical Industry 12
3.4.1 The EU Patient Partnership Project 12
3.4.2 The Drug Information Association (DIA) Patient Fellowship Program 14
3.4.3 The James Lind Alliance 14
3.4.4 Engaging the Pharmaceutical Industry 15
3.5 Overcoming Barriers to Patient Involvement 16
4 Patient Reported Outcomes 17
4.1 Introduction 17
4.2 Regulatory Guidance 18
4.2.1 FDA Guidance 18
4.2.2 EMA Reflection Paper 18
4.2.3 Influence of EMA and FDA Guidance Documents 19
4.3 Using PROs in drug development 20
4.3.1 PRO Instrument Development and the FDA 21
4.3.2 Contract Research Organisations with PRO Expertise 21
4.3.3 PRO Instruments: Sharing and Cooperation 22
4.3.4 Electronic PRO instruments 24
4.4 Conclusions 25