Patient Registry Design and Operations Working Group

Chair: Leanne R. Larson MHA, Vice President, Registry Consulting, ICON Lifecycle Sciences

Goal: to establish good research practices on the design, implementation, and analysis of patient registries to meet the registry sponsor’s desired goal(s), domestically and internationally.

13th Annual International Meeting Presentation
Forum Presentation

Background:
A registry’s design and operation are driven by its classification and strategy, and build upon the foundation established by early and comprehensive planning. Matching program objectives with appropriate design and operational elements, however, requires a complex consideration of desired registry outcomes and impact, as well as potential challenges and solutions.

Successful registry design and operation will also be associated with generation of valuable data; analysis of these data, though, requires an understanding of specific analytic approaches designed to minimize the impact of confounders and other variations.

Project Team 1: Registry Design
Chair: Rich Gliklich MD
Members: Susan Anton PhD, BS, MPH, DrPH; Lusine Abrahamyan MD, MPH, PhD(c);
Sue Elliot PhD, MBA; Matthew Gordon

Identify registry design methods, requirements, and case studies of successful registries.
Develop consensus on design elements to reach specified objectives.
Evaluate how effectively the design meets the internal and external goals.
Recommendations for good practices on patient registry design.

Project Team 2: Registry Operations
Co-Chairs:Shelley Stanley MS RD & Michelle Leavy BA
Members: Elizabeth Hernberg-Stahl MSc, Sonja Wustrack MPH

Examine key components of operating a successful registry and identify challenging areas to explore.
Provide a practical guide to the day-to-day operational issues and logistical decisions for implementing and managing a registry.

Outline

Project Team 3: Registry Data Management and Analysis
Co-Chairs: Maria Malmenäs MSc & Mike Novotny MBA, MA
Members: Lusine Abrahamyan MD, MPH, PhD(c); Hervé Caspard MD; Rebecca Gruhlkey MBA, MA;
Margaret Hux MSc; Michelle Turner MS, BS

Identify needs: registry data collection, management, and analysis
Develop consensus for the best approaches to data analysis
Recommendations for registry data management and analysis good practices.