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How to collect and interpret the real world data that supports your brand and improves patient outcomes
Real world data is being employed across a wide spectrum of pharma’s activities and is proving itself in a range of research, clinical and commercial settings. But how do you distil the huge range of data available into reliable, persuasive evidence and actionable intelligence? How can it be applied to underpin your research, pricing and life cycle management decision making?
Harnessing the Power of Real-World Data is essential reading for market access, sales and R&D planners. Packed with insights, case studies and actionable information, this report identifies the critical issues, “must haves” and challenges of establishing and exploiting effective real world data and evidence strategies. The report is based on the insights and experiences of data analytic and medical affairs professionals working in or with US/European pharma companies
Answering key questions:
- Creating evidence: How can real world data be turned into compelling evidence and what are the main opportunities arising from its analysis and interpretation?
- Sources of real world data: What are the sources of real world data and what are the challenges in collecting them?
- Patient power: Patient reported outcomes are becoming increasingly influential, but data quality is variable. How do you reliably incorporate this rich data source in your analysis?
- Partnering for advantage: Accessing real world data means government, payers, patients and industry must collaborate. What role can industry play in establishing these relationships?
- Working with payers: What role can real world data and evidence play in supporting pricing decisions, ensuring formulary inclusion and securing reimbursement?
- Technology drivers: How is digital technology revolutionising the ways data is being collected analysed and disseminated, and how might this develop in the future?
- Improving research planning: How is real world data helping to refine clinical trial planning and at what development stage should companies be employing real world data inputs?
- Life cycle management: Real world population data can reveal safety issues and potential new indications. How can you incorporate these into a product’s development strategy?
With this report you will be able to:
- Learn from detailed case studies about the role played by real world data in, for example, the UK’s MS Risk-sharing scheme and Salford Lung Study, safety findings with saxagliptin in the US and the Electronic Health Records for Clinical Research project in the EU.
- Drive commercial success by creating compelling evidence based insights that support your brand and position.
- Understand how and where real world data is having significant impact on pharma’s operations.
- Know the sources of real world data and the challenges of analysing and interpreting them.
- Engage with payers and patients to harness the critical data that can lead to better outcomes.
- Gather better information through improved patient support programmes and technology.
- Apply real world data and evidence to refine and align you R&D programme to meeting regulator, physician, payer and patient needs.
Key Topics explored
- It is critical to ask the right questions to get the right answers that support your brand - project planning is crucial.
- Real world data can play a valuable role in combination with formal clinical trials results in securing marketing authorisation, market access and a profitable future for your brand.
- While the amount of data available to industry is increasing, concerns remain about patient confidentiality.
- The more data that are created the more data “noise” is generated – expert analysis is critical.
- Long-term studies based on real world data give a more accurate picture about patient adherence life style choices and behaviour.
- Dr Robin Munro is Director, Real World Evidence and Outcomes, Zephyr Health, UK.
- Nigel Hughes is Director for Integrative Healthcare Informatics at Janssen R&D (Johnson & Johnson), Belgium
- Florent Richy is Head of Global Epidemiology, Merck Serono (Merck KGaA), Germany
- Andy Jones is Vice President of Pharmaceutical Innovation at AstraZeneca, UK
- Brian Schwartz is Senior Medical Director at Intarcia Therapeutics, US
- Edward Tuttle is Managing Principal at Analysis Group, San Francisco, US
- Dr David Leather is Global Medical Affairs Leader, GlaxoSmithKline, UK
- Shailja Dixit is Executive Director, Medical Affairs, Allergan, US (The opinions expressed by Dr Dixit represent her personal views and not those of her corporation)
- A market access expert from a global top 20 pharmaceutical company. He requested anonymity.
2 Research objectives, methodology and definitions
2.3 Experts Interviewed
4 The value of real-world data to pharma
4.1 Real-world data: towards a definition of its role
4.2 From RWD comes real-world evidence
5 The process: how is RWD sourced, processed and analysed to deliver real-world evidence?
5.1 Sources of RWD
5.2 Patient-reported outcomes data
5.3 Responsible access to data
5.4 A sea of data – unlocking the value
5.5 Data access
5.6 The role of data analysis
5.7 Interrogating data: asking the right question
5.8 Collaborations are key
6 RWD to enhance value proposition, market access and sales effectiveness?
7 Use of RWD during the R&D process
8 Technology is the key to obtaining valuable RWD
9 Future prospects and top tips and challenges
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