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Market access and evidence generation: the evolving uses of real-world data

10/1/2023

In this excerpt from our article, “Integrated Evidence Generation 2.0: a strategy for every stakeholder,” we explore the requirements of a wider group of stakeholders to fill their varying information gaps.

Traditionally, research and development teams led the way in evidence generation, leveraging basic translational science and clinical studies to achieve regulatory approval, followed by data generation to achieve label expansion, with limited need to consider evidence requirements beyond the regulatory bodies. However, the results of registration trials often fail to reflect the reality of clinical practice or outcomes in complex patient populations.

Today, real-world evidence (RWE) is becoming increasingly accepted by regulatory bodies, payers, and health technology assessment (HTA) decision makers looking to understand the practical value of therapies for patients. For example, in February 2022, the European Medicines Agency (EMA) established the Coordination Centre for the Data Analysis and Real World

Its vision is to provide the European Union with an invaluable resource of timely and reliable RWE, which will benefit a variety of stakeholders, including patients, healthcare professionals, HTA agencies, and the biopharmaceutical industry. As illustrated by the EMA’s mission, it is not just regulators who are interested in RWE; payers are also laser-focused on how to prepare evidence on the practical application of the product.

By working in collaboration, biopharmaceutical teams can illustrate the evidence needed by regulators and show the real-life application of the product, helping to focus teams on the evidence that matters most to each external stakeholder. This includes maximizing the use of clinical data and RWE to demonstrate value to different stakeholders and establishing comprehensive regulatory frameworks, ensuring compliance.

This excerpt was taken from the free market access article “Integrated Evidence Generation 2.0: a strategy for every stakeholder.” The full article explains why innovative biopharmaceutical manufacturers are thinking beyond the regulators to take a holistic approach to evidence generation that meets the needs of a variety of stakeholders.

Download the article now to learn more about new strategies for evidence generation within market access.

  • Gain insight into developing a multistakeholder approach to evidence strategy that provides a holistic understanding of the product value and maximizes return on investment.
  • Understand how to focus your teams on the evidence that matters most to each external stakeholder.
  • Discover how patient-reported outcomes, collected during clinical trials or as RWE, can be used as a powerful tool to inform regulatory approval.

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