Real-World Evidence Portfolio
RWE Research Partnerships
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Real-world data (RWD) are routinely collected as part of medical care and have the potential to inform regulatory decision-making.
Friends’ Real-World Evidence (RWE) Portfolio aims to generate data that supports the use of RWD to generate RWE that can be reliably applied in oncology drug development and regulatory decision-making.
What is the unmet need and why does it matter?
Real-World Data (RWD) are patient data routinely collected in electronic health records (EHRs), claims data, and registries that can provide valuable insights into the real-world performance of cancer therapies and diagnostics. Unlike traditional clinical trials, which collect data at predefined timepoints under standardized protocols, RWD often vary in timing, completeness, and format within and across sources. Inconsistent definitions and data missingness present challenges to using RWD for evaluating treatment effectiveness, such as assessing a therapy’s impact on survival or its use in certain patient populations. Strategies and methodologies for addressing these challenges are critical to fully realize the potential of RWD.
How are we helping to find solutions?
Friends generates the evidence needed to support the reliable use of RWD in oncology. By facilitating collaboration among RWD companies, pharmaceutical developers, government officials, clinicians, patient advocates, and researchers, Friends advances shared approaches for understanding, defining, collecting, analyzing, and applying RWD and RWE in oncology. These multi-stakeholder partnerships support alignment on best practices, test methodologies for analyzing RWD, and identify opportunities to proactively strategize on future use of RWD/E in oncology.
How does this impact patients?
Traditional clinical trials, such as randomized controlled trials (RCTs), can take several years to complete and often enroll narrowly defined patient populations. This means the study findings may not fully represent a wide range of real-world patients who will eventually receive the therapy in everyday oncology practice. RWD can generate supplemental evidence that reflects a broader, more representative patient population and address timely clinical questions, including use of different treatments in standard of care practice and long-term safety. Additionally, RWD can support evaluations in settings where it may be unethical or otherwise infeasible to enroll patients into a control arm. Without coordinated efforts like those led by Friends and support from collaborative sponsors, the field may struggle to establish aligned best practices and frameworks for aggregating and analyzing RWD effectively.
How does this work inform federal policy?
RWD and RWE are priority areas for the U.S. Food and Drug Administration (FDA). To advance use of these data, the FDA has launched RWD-focused initiatives, including the Center for Drug Evaluation and Research (CDER) Center for RWE Innovation (CCRI), and released several guidance documents on RWD/E in drug development and regulatory decision-making.
Friends identifies opportunities to provide feedback on these initiatives, leveraging data-driven insights from our RWE Portfolio of projects to shape policy recommendations:
- 2024: Friends submitted a public comment on the draft guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.”
- 2024: Friends co-hosted a public event, “Advancing Real-World Data to Generate Regulatory Grade Real-World Evidence in Oncology.”
- 2023: Friends hosted a public meeting, “Supporting the Use of RWD in Oncology Drug Development,” that featured a policy-focused discussion on applying learnings from Friends’ RWE pilots. The discussion centered on supporting the optimal use of rw-endpoints when leveraging RWD-sources in oncology drug development and for regulatory decision-making.
Read more about each of our RWE partnerships at the links below.
External Control Arm Pilot Project:
(ECA Pilot Project)
How can we reliably leverage external data to support the evaluation of new treatments, particularly in situations where traditional randomized controlled trials (RCTs) are not feasible or ethical?
Real-World Response Pilot Project:
(rw-Response Pilot Project)
What endpoints can be evaluated and compared across multiple data sources using a common framework?
Real-World Evidence Pilot Projects:
(RWE Pilots 1.0 and 2.0, rw-Care Pilot)
What is the best approach for evaluating RWD to generate RWE to identify drugs that benefit patients?