The National Institute for Health and Care Excellence (NICE) has updated its real-world evidence (RWE) framework published in June 2022. The framework guides the planning, conduct and reporting of RWE studies, with the objective of improving the quality and transparency of evidence. The framework has been updated to include guidance on external validity bias and the transportability of international data.
The framework includes updates/additions to the following sections:
- External validity: A new section has been added that defines the external validity of study findings in terms of generalizability and transportability. This includes having the analytical sample represent the target population and accounting for differences in patient or disease characteristics, healthcare settings, staff experience, treatment types, clinical pathways, patient exclusions, dropout, and data missingness.
- Sampling methods: Information on different sampling techniques has been added to reduce selection bias in studies requiring primary data collection.
- Addressing external validity bias: The new section provides guidance on the different methods to assess and minimize external validity bias in the analytical sample and target population due to differences in patient characteristics.
At EVERSANA, we recognize the pivotal role that RWE plays within the healthcare sector. As preeminent authorities on indirect treatment comparisons (ITCs) and RWE external control arm (ECA) studies, we are ideally positioned to fulfill our clients’ RWE needs.
For details on how EVERSANA can bolster your RWE endeavors, we invite you to contact us and learn about our array of services.
Author
Dr. Chris Cameron is a global thought leader in health economics and outcomes research with over a decade of experience. Prior to joining EVERSANA, Chris was a partner at Cornerstone Research Group Inc., and…
As an accomplished professional in the healthcare industry, Deepika Thakur brings a wealth of experience and expertise to the table. With over a decade of involvement, spanning roles in both industry and healthcare economic…
Pamela Vo brings over 18 years of HEOR experience in the pharmaceutical industry, showcasing a history of strategically translating ideas into impactful outcomes. She boasts a proven track record of peer-reviewed publications, significant achievements…