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?
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.
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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.
“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
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