Evidence Matters – Why Pharma Needs to Get Serious about Data
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.
Reasons to Purchase
How to use this report
Improve your understanding of the issues
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?
Evidence has become the lifeblood of pharma and offers the potential to smooth the ever-bumpier path towards market access. The key to success is a focused and structured approach with clear objectives and measurable outcomes. But proof of economic benefit is only one part of the puzzle – add in symptom relief, adherence rates, ease of patient access and a whole host of other evidence opportunities and the field widens considerably. For some, the quest for proof has become expensive and disjointed; for others, it offers a route to greater insight and commercial advantage. Pharma must now finely hone its evidence generation strategies if it is to gain a return on its investment and stay ahead of the curve.
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.” Nigel Hughes
“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.” Mike Spencer
“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.”Bonny McClain
The growing role of evidence in pharma
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
RWE: a reflection of reality
Clinical trials: No longer the gold standard?
Clinical trial evidence plus RWE
Opportunities for evidence-based decision making
Is there a need to have a hierarchy for data/evidence types?
What value types can evidence help to generate?
Including ‘expanded’ sources of data
Stakeholders have a hand in it, too
A look inside the evidence toolbox
Challenges to evidence building
Access to data
Trust in the data-sharing model
Availability of quality data
Willingness to invest in change
Overcoming challenges in evidence building
Collaboration and consensus
Implications for organisational structure and culture
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
Strategise for internal and external communication separately
Deliver on time
The future of evidence in pharma
A continued technological disruption for evidence
Greater acceptance for RWE and adaptive pathways
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
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