Your Cart Is Empty!
Patient-reported outcomes (PRO) can refine research design, support new product applications and build powerful evidence of your brand’s value with payers. But how do you create effective PRO instruments, in what settings do they bring greatest value and what developments are on the horizon?
Informed by expert opinion, this report examines the emerging science of PROs and identifies how you can practically build the tools, and apply the techniques, that will harness the power of the patients’ experience for your brand.
“It benefits everybody. It benefits government. It benefits people who pay for the drugs, it benefits insurance companies, industry as well as physicians, because imagine, if patients are cured they won't be coming again and again to the doctor”
Global President of Thyroid Federation International
Answering key questions:
Could do better: Pharma is not fully benefitting from PROs – in what areas could they do better?
Expanding use: In what conditions and therapy areas are PROs playing a key role?
Market Access: How can PRO data be used to enhance market access?
Key PRO ingredients: How can you define a PRO measure and what patient and operational issues do you need to consider when designing a study?
Measuring up: What different types of PRO measures currently available and how might they develop in the future?
Improving research: In what ways can PRO measures be added into clinical trial design to deliver more valuable outcomes?
Payer influence: What PRO data can be persuasive to payers and support pricing?
Guidance: What guidance is available from the FDA, EMA and PRO Consortium on the selection and use of PRO instruments?
Key Topics Explored
PRO measures articulate the patients’ experiences in a structured manner for application across a range of pharma’s activities, but it is essential to design studies that deliver insights not just data.
PRO data is no longer just a “nice to have”. Regulators and payers are increasingly demanding PRO data to support their evaluations.
While traditionally used in pre-marketing settings, PROs are now positively impacting drug applications and post-marketing assessments
Incyte’s Jakafi (ruxolitinib) is seen as a model application of a PRO strategy – what benefits did the company accrue and what lessons can be learnt?
Dr Hendrik-Tobias Arkenau, MD, PhD, Founding Medical Director of the Sarah Cannon Research Institute UK, and Fellow of the Royal College of Physicians.
Ashok Bhaseen, Global President of Thyroid Federation International.
Claire Burbridge. Senior Director of Clinical Outcomes Assessment at Clinical Outcomes Solutions Ltd.
Dr Diego Cadavid, Senior Medical Director, Biogen.
Dr Stephen Joel Coons, PhD, Executive Director, Patient-Reported Outcome Consortium, Critical Path Institute, US.
Dr Gordon Crawford, MD, Director and co-founder of Patients Direct.
Linda Deal, Patient-Centered Outcomes Assessment (PCOA) Lead, Global Health & Value, Pfizer.
Matt Reaney, Head of Patient-Reported Outcomes, Global Health Economics and Outcomes Research, Sanofi.
Sue Vallow, Senior Director and Head of Patient Focused Outcomes at GlaxoSmithKline.
Table of Contents
1 Executive summary
2 Research objectives, methodology and definitions
4 Patient-reported outcomes (PROs): gauging the patient experience
4.1 Defining a PRO
4.1.1 Observer-reported outcomes (ObsRO)
4.2 A more holistic approach to health benefits
4.3 How PRO data differ from other clinical data .
4.4 Growth in the significance of PROs to pharma
4.5 Focus on: Oncology and haematology
5 Growth in PRO measures and their use
5.1 Patient experience is recognised as more than symptoms alone
5.2 The value of PROs pre- and post-marketing
5.3 Payers seek a different approach to understanding the impact of disease
5.4 FDA guidance for industry on PRO measures
5.5 Focus on: The PRO Consortium – liaison with the FDA
5.6 European Medicines Agency (EMA) guidance on PROs
5.7 Patient centricity is a key driver of growth in PROs
5.8 Case study: Jakafi, one of the first successful uses of PROs for product approval with the FDA .
5.8.1 Structure of the Jakafi PRO
6 PRO measures, instruments and classification
6.1 Categories of PROs
6.2 Which PRO measure? Choosing the right one to suit your needs
6.3 Types of PRO measures and the tools used to obtain data
6.3.1 Quality of life
6.3.2 Generic PRO e.g. SF-36 (Short Form-36)
6.3.3 Utility measure
6.3.4 Disease/condition-specific PROs.
6.4 Patient-centric outcomes
7 Development of a PRO instrument to capture optimal PRO data
7.1 Determining and developing PRO instruments optimal to the data required
7.1.1 Guidance on development of PRO instruments
7.2 Timing and development of PRO measures
7.3 Instruments to capture PRO measure data
7.3.1 Quantitative data, qualitative data and questionnaires
7.4 PRO instruments obtain individual-level data
7.5 Data capture with electronic PROs (ePROs)
7.6 Other methods of data capture
8 Teasing out the value of PROs for payers, pharma and patients
8.1 What the experts say about the value of PROs
8.2 The added value of PRO measures for different stakeholders – benefits and limitations
8.3 PROs can help predict a product’s chance of success with reimbursement authorities/HTA
8.4 What payer and reimbursement authorities expect from PRO measures
8.5 How PRO measures can improve market access
8.6 Employers as payers in the US
8.7 PROs: pharma’s opportunity to improve the product offering and achieve success
8.8 PROs can drive pharma innovation
8.9 Are companies fully grasping the opportunities and values associated with use of PRO measures?
9 Down the road – opportunities and challenges for PROs over the next 5-10 years
9.1 Redefining ‘good outcomes’
9.2 New PRO measures and PRO instruments will be developed
9.3 Reimbursement authorities will place more emphasis on PROs
9.4 Improvements in the interpretation of PROs
9.5 PROs will be recognised for their value in understanding patient compliance
9.6 PRO measures and PRO instruments are set to expand in number and become more refined, improving the patient experience
9.7 PROs need to be incorporated into treatment algorithms
9.8 Greater engagement with PROs by physician and patients associations
9.9 Technology will drive PRO measure development and use
9.10 Increased emphasis on post-marketing use
9.11 PRO assessment in combination with performance measures
9.12 Making the case for the value of PRO assessment
9.13 Feedback from authorities on PRO measure development
Following are different modes of Licenses.
a. Single User License:
This license allows only one person to use the report. This person can use the report on any computer and may take print outs of the report but must take care of not sharing the report (or any information contained therein) with any other individual or people. Unless you purchase a Site License or a Global Site License, a Single User License must be purchased for every single person that wishes to use the report within the same enterprise.
b. Single Site License:
This license allows unlimited users to use the report within one company location, e.g. a regional office. These users can use the report on any computer and may take print outs of the report but must take care of not sharing the report (or any information contained therein) with any other individual or people.
c. Global Site License:
A Global Site License (or Enterprise wide Site License or Global License) is a license granted to original purchaser, who can share a report with other employees and authorized Users of the same organization.
1. How do you deliver the reports?
The delivery of reports is depends on format & mode of license of report(s). Following are different kinds of formats of report(s) and their delivery options :
a. Electronic Format – Through email from Publisher
Report will be sent to your username email address in PDF, Excel, PowerPoint or any other electronic / softcopy format by publisher.
Delivery Time: 12 to 48 hours [depending on time difference or occurrences of national holidays]
b. Hard Copy or Printed Format or CD-Rom – Through Mail or Courier from Publisher
Report will be sent through mail / courier delivery to your shipping address by publisher.
Delivery Time: Less than, few weeks [depending on time difference or occurrences of national holidays]
2. How can I make payment for publications I purchase?
You could be able to make the payment, in following ways:
a. Online Secure Payment through Credit Card Payment : We accept Visa, Master, AMEX Cards & CCAvenue
b. Transfer of fund to our bank account via Bank transfer or Wire transfer
c. Payment via DD or Cheque
3. Is it safe to use my credit card on MarketinfoResearch?
Your personal information and online tranaction on Marketinfo Research is secure, private, and tamper-proof. All credit card payments are processed through secure and trusted payment gateways.