Brinda Sriskantha, PhD, Director, Real World Solutions, IQVIA MedTech and Michelle Bulliard, Vice President, Real World Solutions, IQVIA MedTech
Regulators have been steadily increasing their use of real world evidence (RWE) to support decision-making. Simultaneously, access to real world data (RWD) continues to increase, and there’s growing clarity on how RWD can be used to generate relevant and reliable RWE. RWD can come from multiple sources including electronic health records (EHRs), claims data, and registries, and can be collected directly from the patient via connected devices such as wearables. Additionally, with more mature digital analytics, we now have the ability to draw insights from health-related data.
Against this backdrop, RWD and RWE are being used in even more applications across the product lifecycle, from proof of concept to patient care. In this three-part series, we’ll explore how RWE is being used to support regulatory decision-making for medical devices, describe some of the RWD sources available to medical device companies, and share some real-life case studies in which medical device companies are demonstrating value of their products through the use of RWD.
Over the last few years, regulators have been increasingly accepting the use of RWE in regulatory decision-making. In general, regulators are increasingly looking at how RWE can be used to support monitoring the safety, effectiveness, and performance of medical devices, as well as the long-term benefit/risk profile of products.
U.S. regulators have stated that “By unleashing the power of RWE, we can accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety.”1
The following are examples of guidance documents that are supporting the industry in its ability to ‘unleash the power of RWE.’
Regulators around the world are more accepting of RWE than ever before. With the increase in guidance frameworks, regulations, and publications, this is paving the way for multiple stakeholders to embrace it. Payers, for instance, can leverage RWE to assess the value of products and to monitor their use, physicians can use it to support and improve clinical decision making, and, ultimately, patients can better understand their treatment options and be more involved in their treatment decision making.
The next installment in our series details several datasets that may be useful to medical device developers in producing evidence for regulators and payers.
1 Shuren, Jeff, MD, JD, Director, Center for Devices and Radiological Health and Caños, Daniel, P:hD, MPH, Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality
2 U.S. Food and Drug Administration (FDA), Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
3 Medical Device Innovation Consortium (MDIC), External Evidence Methods Framework
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