Richard Willke, PhD
Chief Science Officer
Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap
Real-world evidence; Non-interventional studies; Health economics; ISPOR; Transparency; Reproducibility
- ISPOR is an international, multistakeholder nonprofit dedicated to advancing health economics and outcomes research excellence to improve decision making for health globally.
- Key characteristics of credible and useful real-world evidence include:
- Careful data collection or curation
- Appropriate analytic methods
- Good procedural practices for transparent study process
- Replicability and reproducibility
- Informed interpretation
- Fit-for-purpose application
- For transparency, it is recommended that researchers declare their study to be an exploratory (hypothesis evaluation) study and post the study protocol and analysis plan on a public study registration site prior to conducting the study analysis.
A draft white paper, Improving Transparency in Non-Interventional Research, is available for comment until November 15, 2019.
Sharing all study implementation parameters and definitions provides clarity on what was actually done and enables reproduction with confidence.
Potential registries for non-interventional real-world evidence studies include:
Read more about ISPOR.
#pctGR, @Collaboratory1, @ISPORorg