LET'S GO FLY A KITE - MANAGING THE WINDS OF CHANGE IN REAL WORLD EVIDENCE STUDIES

Author(s)

Andrew Bate, PhD, Pfizer Ltd, Surrey, UK; Alison Bourke, BSc, MSc, IMS Health, London, UK; Gillian C Hall, PhD, Gillian Hall Epidemiology Ltd, London, UK

PURPOSE: Sustainability issues, such as data continuity and access, and associated methodology can impact on many health economic/outcomes studies. This workshop will highlight these issues and discuss how internal and external factors, such as clinical practice and legal frameworks, should be considered during study design. The workshop will provide guidance on how to minimize the impact of change. DESCRIPTION: In our continually evolving research environment, change is inevitable; such changes commonly involve the addition of more recent data, but also may relate to alterations of the data model, tools, data elements or even healthcare environment. These changes can impact our research, but are we good at anticipating and managing such change? The importance of change management is recognized in a recent publication providing guidance and a checklist to help plan for change in observational healthcare database studies (Bourke et al, Pharmacoepi and Drug Safety. In press). A panel of researchers and data providers will first explain change issues and illustrate why sustainable design is a key consideration in real world data (RWD) research. The importance of change management to the validity, transparency and reproducibility of database studies will be outlined, then the audience will be split into Working Groups to use the published checklist as a tool to identify and consider change across simulated HEOR studies. The Discussion Leaders will facilitate an interactive conversation with workshop participants incorporating feedback from the Working Groups on how changes can affect studies and whether such changes can be anticipated. This interactive workshop will help to plan strategies for sustainability for both researchers and database providers. The workshop will provide participants with change management competencies by creating an interactive environment for attendees to learn about the issues and to practice effectively planning RWD studies

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Code

W11

Topic

Methodological & Statistical Research, Real World Data & Information Systems

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