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Decoding EMA’s Blueprint on Real-World Evidence

The European Medicines Agency (EMA) has published a document that elaborates on the application of Real-World Data (RWD) in evaluating human medicines. This document succinctly outlines the utility of Real-World Evidence (RWE), which is derived from RWD analysis, within the scope of regulatory decision-making. It details the types of studies that can be conducted, how the EMA can pinpoint optimal resources to address research inquiries, and the procedure for requesting RWD studies.

Here are the three pivotal findings from the EMA report on RWE:

  • RWE Generation Pathways: The EMA has delineated three principal avenues for RWE production: the Data Analysis and Real World Interrogation Network (DARWIN EU), in-house electronic health databases, and studies secured through EMA framework contracts. Each pathway provides distinct capabilities for generating solid evidence.
  • Utility of RWD Studies: Studies based on RWD are vital for bridging knowledge gaps, supplying independent evidence, presenting customized analyses, and potentially expediting evidence generation. These aspects considerably bolster the processes of regulatory decision-making.
  • Operationalization of DARWIN EU: As of February 2024, DARWIN EU has been fully operational, establishing itself as the foremost conduit for RWE creation at the EMA. This network is poised to substantially expand its study capacity, with aspirations to conduct up to 150 studies by 2025, thereby hastening the provision of high-caliber RWE.

The document also sheds light on the types of queries RWE can resolve, the methodology for soliciting RWD studies, and the anticipated timelines for study finalization. With DARWIN EU’s comprehensive operation, the EMA reaffirms its dedication to supporting robust and methodologically sound evidence to aid regulatory submissions.

The document also details the types of studies that can be conducted, the strategies employed by the EMA to identify optimal resources to address research inquiries, and where RWE can support regulatory decision-making:

  • Supporting the Planning & Validity of Applicant Studies: RWE plays a crucial role in supporting the planning and ensuring the validity of applicant studies. By leveraging data from real-world clinical settings, researchers can assess the feasibility of planned studies, ensuring that they are designed to reflect actual clinical practice and patient outcomes. This can lead to more efficient study designs and a greater likelihood of generating meaningful evidence that resonates with regulatory bodies.
  • Understanding the Clinical Background: RWE is instrumental in understanding the clinical background against which medicines are evaluated. This includes gaining insights into epidemiology, clinical management, and drug utilization patterns. Such information is vital for contextualizing the safety and efficacy of medications within the broader spectrum of healthcare delivery.
  • Investigating Impact and Associations: When it comes to investigating the impact and associations of medical interventions, RWE is invaluable. Effectiveness and safety studies that utilize RWE can uncover associations between interventions and outcomes that may not be evident in controlled trial settings. This can inform regulatory decisions by providing a more comprehensive view of how a medicine performs in the real world.

At EVERSANA, we recognize the pivotal role that RWE plays within the healthcare sector. As preeminent authorities in Indirect Treatment Comparisons (ITCs) and RWE-External Control Arm (ECA) studies, we are ideally positioned to fulfill our clients’ RWE necessities.

Whether it involves maneuvering through the intricacies of RWE generation or deciphering the ramifications of the latest EMA directives, EVERSANA is primed to work with our clients at every juncture. For further details on how EVERSANA can bolster your RWE endeavors, we invite you to reach out to us and delve into our array of services.

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Chris Cameron, PhD
Chief Scientific Officer

Dr. Chris Cameron is a global thought leader in health economics and outcomes research with over a decade of experience. Prior to joining EVERSANA, Chris was a partner at Cornerstone Research Group Inc., and…

Deepika Thakur
Senior Director, HEOR

As an accomplished professional in the healthcare industry, Deepika Thakur brings a wealth of experience and expertise to the table. With over a decade of involvement, spanning roles in both industry and healthcare economic…

Pamela Vo

Pamela Vo brings over 18 years of HEOR experience in the pharmaceutical industry, showcasing a history of strategically translating ideas into impactful outcomes. She boasts a proven track record of peer-reviewed publications, significant achievements…