?️Sounds of Science Podcast #17 on Real-World Evidence (RWE)

EUCOPE’s Sounds of Science Podcast – Episode 17

Real-World Evidence (RWE): The need for a multi-stakeholder approach

Within the EU, the life sciences industry requires a strong innovation framework across the patient journey so that such technological advancements can be used to the benefit of all stakeholders. Clinical studies have and always will be the foundation to assess the efficacy and safety of new therapies. However, the rise and use of real-world evidence (RWE) can complement clinical studies, and in many cases, provide answers to questions that cannot be addressed by randomized clinical trials (RCTs).

In this episode of Sounds of Science, we explore the topic of real-world data (RWD) and RWE – that is data that is collected in a real-world setting, such as in healthcare institutions rather than through controlled experiments. We examine how this information can be useful for biopharma companies and health authorities in order to help deliver better outcomes for patients and have a positive impact on the overall healthcare system.

We also delve into some of the challenges with using this type of data, and we will see how a multi-stakeholder initiative – RWE4Decisions – is tackling those issues. Our special guests include:

• Karen Facey, Senior Advisor HTA, RWE4Decisions
• Carlos Martin Saborido, Scientific Officer, Spanish Ministry of Health
• Alexander Natz, Secretary General, EUCOPE

This episode is hosted by EUCOPE’s Communications Manager, Dante Di Iulio.

You can listen to Episode 17 and all other Sounds of Science podcast episodes using the links below:

• Apple Podcasts

• Anchor.fm

Episode Highlights

• Karen Facey, RWE4Decisions

“It is so exciting to have all those real-world data that could be used to tell us about the real-life, long-term effectiveness of a new treatment in our own health system. But we need to bring those messy real-world data together and carefully analyse them to create good real-world evidence.”

“We need to continue to think about the lifecycle approach to RWE generation, identifying very early when we might need RWE for evaluation of medicines by regulators or HTA and then for conditional reimbursement and treatment optimization.”

• Carlos Martin Saborido,  Spanish Ministry of Health

“A well-designed RWE management will play an important role in a time where the evidence for some new treatments is weak due to a lack of comparators, small samples, short follow-ups and surrogates variables.”

“Another critical issue is transparency. So far, data are not public and only reports on each and every drug is published whenever possible. A shift to an interactive dashboard within our sysem is in production to make timely data available to everybody.”

• Alexander Natz, EUCOPE

“RWE should not be seen as replacing RCTs, however, for certain therapies RCTs are not feasible, thus RWE can play an important role to ensure patients can access innovative therapies in a timely manner. The potential for more informed decision-making, when it comes to payers’ decisions with the use of RWE in pay-for-performance models should also not be dismissed.”

“The European Health Data Space (EHDS) has the potential to accelerate the use of RWE, however in order for it to do so it will be important to reach a critical mass of data – something which can only be achieved if enough citizens consent to sharing their health data. Therefore, an opt-out mechanism for consent should be included in the proposal rather than an opt-in mechanism, as the latter could lead to too low participation.”

 

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For more information on EUCOPE’s initiatives with Real-World Evidence or how your organisation can contribute to it, please contact Matias Olsen olsen@eucope.org

If your company would like to put forward a topic for us to discuss or to participate in a future podcast episode, please reach out to our producer, Dante Di Iulio.