RWE Considerations Throughout Product Development Cycle

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Drug manufacturers can use real-world evidence (RWE) before and after approval to advance product development and adoption.

Real-world evidence (RWE) demonstrates actual patient outcomes that complement clinical evidence, offering invaluable perspectives on the patient’s journey. RWE is obtained through a combination of quantitative and qualitative real-world data (RWD) sources such as electronic health records (EHRs), patient-reported outcomes, caregiver-reported experiences, and patient data from wearables or mobile devices.

Applications for RWE

In recent years, recognition of the value of RWE has been growing among healthcare stakeholders, including pharmaceutical companies, medical device manufacturers, health plans, and governmental agencies. Because RWE can provide insights into healthcare delivery and utilization outside the controlled context of clinical trials, stakeholders are increasingly using RWE to inform decision making for drug development, regulatory approvals, market access, and reimbursement.

To date, sponsors have primarily used RWE to meet regulatory requirements in post-market approval and monitoring and to demonstrate value propositions with payers, providers, and others. However, stakeholders may apply findings derived from RWE throughout the product development cycle to improve patient’s treatment adherence, access, and adoption.

Specifically, RWE can be used to:

  • Fill in evidence gaps such as incidence estimates for specific sup-populations
  • Reduce patient recruitment costs during clinical trials and increase engagement with underrepresented subpopulations
  • Create ethnically and racially representative datasets
  • Integrate data not routinely captured in clinical research, such as social determinant of health variables
  • Expand insight into the rare disease space where recruitment is challenging, and randomized controlled trials are often insufficiently powered for findings to be generalizable
  • Inform provider prescribing choices and treatment options based on observed drug interactions based on frequency of use in the patient population of interest

US and European Landscapes

Numerous factors have accelerated the adoption of RWE, including an industry-wide shift from volume- to value-based care payment models, personalized medicine, and the need to adapt clinical trials during the COVID-19 pandemic. For these reasons, RWE is anticipated to continue playing an increasingly bigger role in regulatory approvals, coverage, and access of innovative medicines.

The incorporation of RWE into pre- and post-drug approval efforts recently gained further momentum with the launch of the Food & Drug Administration’s (FDA) Advancing Real-World Evidence Program in October 2022. The program offers selected sponsors the opportunity to meet with FDA staff prior to beginning clinical studies to discuss the use of RWE in medical product development. The FDA may also publicly present study designs through this program to promote awareness of how RWE may support regulatory decisions.

Though RWE effectiveness and value has been thoroughly highlighted, obstacles to turning this collected data into something of tangible value remain. To begin to address challenges inherent to the collection and evaluation of real-world data, the US Department of Health and Human Services’ Office for the National Coordinator for Health Information Technology has been made responsible for advancing interoperability between patient data sources and EHR registries. This task has been further highlighted under provisions of the 21st Century Cures Act, which is centered on barrier reduction in the utilization of RWE.

One immediately available approach to increase and standardize RWD collection and subsequent RWE generation is to develop guidelines and regulations for data transfer and coordination within RWD registries. Registries are commonly used in clinical research and provide a valuable source of data not otherwise captured in standard studies and clinical workflows. For example, sponsors in the European Union seeking marketing authorization and indication expansion frequently use disease registries in the post-marketing space. To remove interoperability constraints that may impede RWE access, the European Medicines Agency released a draft guidance in 2021 for marketing authorization applicants to guide RWD studies based on registry data. Overall, Health IT industry-led initiatives to make EHR data collection and transfer to registries more seamless demonstrate how regulations and the technology itself are maturing.

Next Steps

RWE has multiple applications for the life sciences industry, including post-market surveillance, product labeling changes, value demonstration, and regulatory decision making. Understanding and applying suitable inputs, data collection, and patient engagement strategies are key for maximizing its future impact.

Avalere applies our expertise in RWE generation and collection, health technology advancements, and patient-centered care to help healthcare stakeholders identify, collect, and analyze relevant RWD to reach their business objectives. To learn more about how Avalere can help you translate those findings into policy advocacy, patient and provider communication, and reimbursement strategies, connect with us.

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