Real-World Evidence Policy Core Competencies for Today and Tomorrow’s Learners

Real-world evidence (RWE) comprises information or analytical insights derived from real-world data (RWD) sourced from a variety and growing range of uncontrolled or dynamic settings (e.g., non-controlled trial settings). RWE policy is an area of study, research, and practice that concerns the development and implementation of strategies to incorporate RWE into important decision-making settings.

RWE is a complex and cross-cutting topic that touches many areas of science policy, practice, and education. As a result, several standalone initiatives seek to meet practitioners’ current and future educational needs across various educational backgrounds. The Duke-Margolis Institute for Health Policy, for example, previously developed a broad health policy core competency framework. Other organizations have similarly developed competency frameworks and educational opportunities that intersect or engage with RWE. These include the:

International Society for Pharmacoepidemiology’s (ISPE) core competencies and educational programs
Professional Society for Health Economics and Outcomes Research’s (ISPOR) health economics and outcomes research (HEOR) competencies framework, and
Academy of Managed Care Pharmacy’s RWE essentials training program.

The Duke-Margolis Institute for Health Policy’s RWE policy team created RWE Policy Core Competencies to effectively bridge previous educational efforts in experiential settings and support the current and next generation of RWE policy practitioners. The competencies are inspired by the Institute’s existing health policy core competency framework areas specific to Health Care System & Policy Process, Policy Development & Evaluation, Data & Methods, and Policy Translation & Communication.

About the Duke-Margolis Real-World Evidence Policy Core Competency Framework

The RWE policy core competencies were developed and informed based on feedback from the Institute’s RWE Collaborative, the Institute’s education team, and a literature review. Based on this analysis, the RWE team identified 12 RWE policy core competencies across two domains: Policy Development, Evaluation, Translation & Communication and Data & Methods. Together, the competencies reflect a versatile, interdisciplinary skillset that will prepare tomorrow’s RWE policy leaders to solve today’s—and tomorrow’s—toughest RWE policy challenges with evidence, innovation, and impact.

Expand each domain below to view the individual competencies:

Policy Development, Evaluation, Translation, & Communication

Description:

Ability to understand and critically evaluate the role and interests of multiple stakeholders focused on advancing RWE policy to accomplish a variety of goals, including but not limited to clinical trial efficiency; building and sustaining learning health systems; effective scientific communication and engagement; and trustworthy translation of novel products, methods, and concepts. Entails awareness of relevant past and present policy priorities and future opportunities to support evidence-based, patient-centered care; supporting clinical trial innovation; navigating regulatory complexity; and maximizing population health.

Rationale:

A strong understanding of historical and current trends, perspectives, and priorities driving the need or demand for data derived from naturalistic or real-world settings is required for professionals seeking to communicate data- or analytics-driven insights to a variety of key stakeholders.

Competencies:

1.1. Review historical foundations of RWE policy, as well as current national and international policy priorities relevant to RWE.

1.2. Describe multi-stakeholders' (e.g., regulatory, health technology assessment body, health system, industry) role and interest in advancing or shaping RWE policy.

1.3. Formulate communication strategies to reach broad audiences—scientific and nonscientific—including policymakers, who may require help navigating complex RWD/E concepts, methods, and relevant literature.

1.4. Assess the role of health systems and complex decisions made within them to accrue, store, manage, and share patient data and implement RWE-based guidance.

1.5. Examine or predict upstream and downstream impacts that RWD/E generation and related policies have on health care delivery and other broad societal considerations.

1.6. Summarize the role and importance of RWE in clinical and translational science, including ethical, legal, and social implications across the RWE lifecycle.

Data & Methods