International Harmonization of Real World Evidence Standards Dashboard

Since 2018, the Duke-Margolis Institute for Health Policy’s Real-World Evidence (RWE) Collaborative has convened stakeholders representing medical product developers, data companies, payers, research groups, providers, patient networks, as well as experts on regulatory affairs, law, health and data science, and policy, with a shared goal and interest to advance RWE policy. This effort includes convening stakeholders who hold shared goals to advance RWE policy among international agencies, health technology assessment bodies, and regulators. To learn more about the Duke-Margolis RWE Collaborative and RWE research portfolio, contact Dr. Rachele Hendricks-Sturrup.

With ongoing support from our RWE Collaborative members, the Duke-Margolis RWE policy research team developed the International Harmonization of Real World Evidence Standards Dashboard with the primary goal of helping internationally-focused RWE policy stakeholders track, in one place, relevant and timely regulatory guidance, frameworks, international harmonization documents, and more.

Share your suggestions or potential updates for the Dashboard by contacting Maryam Nafie, Molly Shields, and Valerie J. Parker.

We would like to acknowledge Eric Monson, Ph.D., within the Duke University Libraries’ Center for Data and Visualization Sciences for advising and assisting our project team in the development of this Dashboard.

Hover over the three icons at the bottom right to share a link to the Dashboard, download it, or view it in full-screen mode.

The documents listed below are non-guidance documents from regulatory agencies that include RWE related strategy documents and reports.

Global:

• Joint FDA and EMA Guiding Principles of Good AI Practice in Drug Development
• Glossary of ICH terms and definitions Compiled by CIOMS from the International Council for Harmonization (ICH)’s QSEM Guidelines
• Final ICH M-14 General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real World Data for Safety Assessment of Medicines
• Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII
• ICH Harmonised Guideline-Guideline For Good Clinical Practice E6(R3)
• IDERHA's D6.2 Report on Global Regulatory Best Practices Analysis: A scoping review of HTA and Regulatory RWD/RWE policy documents
• Draft ICH M-14 General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicine
• Final CIOMS Working Group Report: Real-world data and real-world evidence in regulatory decision-making
• Theraputic Goods Administration (TGA) Real World Evidence Webpage
• ICH Reflection Paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines
• ICMRA Statement on international collaboration to enable real-world evidence (RWE) for regulatory decision-making
• ISPOR, ISPE, the Duke-Margolis Center for Health Policy and the National Pharmaceutical Council Real-World Evidence Transparency Initiative

Publications citing our dashboard: 

• Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

• Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies

• Global Regulators Enhance RWE Standards with New Dashboard

• A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators

• CIOMS December 2024 Newsletter

• IDERHA's D6.2 Report on Global Regulatory Best Practices Analysis: A scoping review of HTA and Regulatory RWD/RWE policy documents

• The maze of real-world evidence frameworks: from a desert to a jungle! An environmental scan and comparison across regulatory and health technology assessment agencies

• Setting the stage to shape the international harmonization of real-world evidence standards

• Duke-Margolis Center for Health Policy releases International Harmonization of Real-World Evidence Standards Dashboard

Last updated: 1/23/25 to include:

• Joint FDA and EMA Guiding Principles of Good AI Practice in Drug Development