Real World Evidence: Creating a forward-focused strategy
In today’s highly scrutinised drugs marketplace, pockets continue to be squeezed and the list of demands from every quarter lengthens. Against this challenging backdrop, every decision made must be backed up by evidence. But exactly what evidence is required by whom, and how should it be prioritised, gathered, interpreted and leveraged for optimum effect?
Find out how to leverage evidence for commercial gain
Evidence Matters: Opportunities for Evidence Based Decision-Making breaks down the extensive challenges of evidence creation into manageable segments and gives pharmaceutical companies actionable insights to build clinical, societal and commercial value. Drawing upon detailed interviews with 10 pharmaceutical data experts, this report offers expert views and practical guidance on how to address the many challenges, including those emerging from the Real World Evidence (RWE) arena.
With increased pressure to contain costs, justify investment choices and respond to changes in the market, the emphasis on the importance of evidence has become a common fixture in the discussions between the pharmaceutical industry and various healthcare decision-makers. Each decision that healthcare stakeholders make will need to be worthwhile for patients, the healthcare system and for themselves. However, the evidence landscape is evolving, and within that evolution multiple opportunities to drive value have become available. Given some of the current issues regarding market access for new and innovative products and services, a question must be addressed: Do pharma companies take the role of evidence seriously?
Based on the findings of this report, pharma has always recognised the significant role and potential of evidence in decision making, but a bigger question around the contents, technical support and considerations that should go into the process of generating evidence emerges.
This report places a spotlight on the growing and aggressive influence of real-world evidence (RWE) on pharma and healthcare. The advantages and disadvantages of using RWE versus clinical trial evidence are included. In addition, this report provides a discussion on why experts suggest that pharma must become better at adapting to real-world information and how the industry can make that happen.
Demonstrating value is often a requirement from payers and health technology assessment (HTA) agencies, but value can mean different things to different stakeholders. Within this report, 10 experts provide their insights into the key areas where evidence utilisation could be most productive and impactful at demonstrating value. Furthermore, value is outlined from clinical, commercial, social and organisational standpoints.
Strategic rigour, creativity and other components of an evidence ‘toolbox’ for understanding and generating evidence are discussed in detail. Such components are critical to optimising the potential of data and demonstrating value to multple stakeholders. They are also key ingredients in overcoming the typical challenges in data management, such as access, interoperability, quality and ownership.
With Big Data, it becomes increasingly clear that data is messy and the right talent must be recruited to deal with this. But who should handle the evidence generation process? What are the characteristics of people who are capable of handling evidence? And who should utilise the evidence once it is available? Experts in this report share their roles and responsibilities, as well as those of the teams they lead within their respective organisations, to explain the necessity of employing the right mix of talent, skills and capabilities for post-launch studies, evidence generation and evidence communication.
The key take-aways gathered throughout the report suggest the significance and strategic potential of evidence for all stakeholders in pharma and healthcare. This importance will continue to grow well into the future.
©Doctor’s Guide Publishing Limited. This executive summary is provided for commercial evaluation purposes only. It can be shared with colleagues for this purpose but cannot be reproduced, extracted or published without the express permission of the publisher.
How to use this report
- Tap into honest and informed insight into the current evidence issues and the differing perspectives of physicians, payers and patients.
- Understand the key challenges, including data-sharing, interoperability and data ownership.
Drill down to the detail
- Get to grips with the relationship between clinical trial evidence and RWE.
- Understand which audiences need what data and why.
See where the value lies and how to maximise it
- Identify the evidence nuances and opportunities when assessing potential value from a clinical, commercial, societal and organisational perspective.
- Discover more about the growing role of evidence across multiple areas as well as the value it generates.
- Shape your evidence strategy, understand specific challenges and devise a methodology to overcome them.
Take practical steps towards success
- From data sources and tools to organisation structure, culture and communications – find out what to do and why.
- Discover new ideas and approaches, including how to shape evidence, implement creativity and execute collaboration strategies.
- Use key action points such as the evidence toolbox, recruiting for vital roles, organisational structure and communication strategies.
Why is evidence so important now?
This report answers key questions
- What are the key differences between evidence from clinical trials and real-world studies? Why are both vital to maintain?
- What are the key obstacles and challenges to effective evidence collection and how can pharma overcome them?
- Which types of evidence are most relevant? And what generates the most value for which key audiences?
- How important is evidence to pricing, reimbursement and market access? What difference can strategic rigour and creativity make?
- From an organisational perspective, what roles and skills are crucial to effective evidence generation and usage? Is external help necessary?
- How should evidence be communicated for optimum effectiveness?
- How is RWE expected to evolve, particularly over the next 5 years?
10 senior experts were interviewed for this report. Each has significant experience of real world evidence and its current processes, value and usage. One of our experts chose to remain anonymous.
- Hassan Chaudhury, Chief Commercial Officer and Co-Founder, Health iQ
- Nigel Hughes, Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
- Bonny McClain, CEO Data & Donuts and US Consultant and Medical IDEAtor, IDEA Pharma
- Mike Spencer, Head of Real World Evidence, EMEA and Chair of the Global Real-World Evidence Leadership Team, Janssen (J&J)
- Ivan John Clement, Data Scientist (R&D and Real-World Evidence), Big Data and Quantitative Sciences, Merck & Co. (MSD)
- Clément François, Vice President, US Health Economics and Outcomes Research, Lundbeck
- Sophie Janssens, Vice President of Global Head Real World Evidence, UCB
- Rob Briner, Professor of Organisational Psychology in the School of Business and Management, Queen Mary University (QMU)
- Steven Pashko, President, Steven Pashko LCC and Integrative Psychological Services LLC
- Anonymous, Executive Director for HEOR at one of the world’s top 20 pharmaceutical companies in Europe
3 Key Quotes
“Certainly, rigour in evidence generation lies with the people. Often, people buy data, but then what? Does it actually answer the questions we face? So, you have to start with a question and build your strategy around it.”
“In the end, what we sell really is the proof that our products work. Now we see that it is not only the regulators that we need to generate evidence for. Clinical trial evidence and RWE are not completely separate things. Health economics teams and R&D teams should not have separate planning. Across the industry, we are seeing the benefit of integrated evidence generation. A part of that is working in a pre-competitive space through public-private partnerships.”
“We have health economics, health policy and medicine, which constitute a three-legged stool. Take one out and it’s not going to get you the solution.”
- Executive summary
- Experts Interviewed
- Research objectives
- The growing role of evidence in pharma
- Key insights
- Lower return on R&D investments
- Expanding payer/HTA requirements
- Increase in data types and tools
- Companies are on the move towards data science
- Real-world versus clinical trial evidence
- Key insights
- RWE: a reflection of reality
- Clinical trials: No longer the gold standard?
- Clinical trial evidence plus RWE
- SWOT analysis
- Opportunities for evidence-based decision making
- Key insights
- Is there a need to have a hierarchy for data/evidence types?
- What value types can evidence help to generate?
- Clinical value
- Commercial/economic value
- Societal value
- Organisational value
- Shaping evidence
- Key insights
- Including ‘expanded’ sources of data
- Stakeholders have a hand in it, too
- A look inside the evidence toolbox
- Challenges to evidence building
- Key insights
- Access to data
- Trust in the data-sharing model
- Availability of quality data
- Data ownership
- Willingness to invest in change
- Overcoming challenges in evidence building
- Key insights
- Strategic rigour
- Collaboration and consensus
- Implications for organisational structure and culture
- Key insights
- An evidence team
- An evidence leader
- Finding and training data science leaders
- Who is responsible for post-launch evidence?
- What should internal stakeholders keep in mind when it comes to evidence communication?
- Plan ahead
- Strategise for internal and external communication separately
- Deliver on time
- The future of evidence in pharma
- Key Insights
- A continued technological disruption for evidence
- Greater acceptance for RWE and adaptive pathways
- Early interception
- Expert biographies
- R&D investment returns of top 12 pharmaceutical companies at a six-year low in 2016
- The importance of RWE over clinical trial evidence
- Patient population studied during clinical trials does not perfectly represent the real-world
- SWOT Analysis of evidence generation and utilisation
- The steps in the decision-making process
- The clinical benefits of RWE generation
- The commercial benefits of RWE generation
- The value types evidence-based decisions can generate
- Evolving health data ecosystem
- The eight Chief Data Officer archetypes
- What data scientists spend the most time doing
- The critical components contributing to the novel approach of I-SPY 2