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Evidence Matters – Why Pharma Needs to Get Serious about Data

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?

Expert Views

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

Content Highlights

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

Interoperability

Data ownership

Willingness to invest in change

Overcoming challenges in evidence building

Key insights

Strategic rigour

Creativity

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

Conclusion

Expert biographies

Figures

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

About FirstWord

FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.

FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.

FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.


1. Executive summary
2. Experts Interviewed
3. Research objectives
4. The growing role of evidence in pharma
4.1 Key insights
4.2 Lower return on R&D investments
4.3 Expan

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