RTI Health Solutions recently posted a simple guide to help understand the upcoming ISPOR/ISPE real-world evidence guidelines.
Below are a couple guidelines RTI breaks down in its post:
- Determine and declare that a study is either a Hypothesis Evaluation Treatment Effectiveness (HETE) study or an exploratory study.
- Post a HETE study protocol and analysis plan on a public study registration site prior to conducting the study analysis.
- Publish HETE study results with atestation to conformance and/or deviation from the study protocol and original analysis plan. Possible publication sites include medical journals or publicly available web-sites.