Improving Transparency And Credibility Of Real-World Evidence Research: The HARPER Protocol Template

Real-world evidence is playing a larger role in healthcare decisions, but confidence in that evidence depends on whether researchers clearly document how studies are designed, conducted, and analyzed. The HARmonized Protocol Template to Enhance Reproducibility (HARPER), developed jointly by ISPE and ISPOR, establishes a consistent framework for planning and reporting real-world evidence studies.

HARPER combines narrative sections, structured data tables, and a visual study design diagram to capture critical details, including research questions, study populations, data sources, outcomes, statistical analyses, missing data, and protocol changes. This standardized approach can help reviewers assess whether research is fit for purpose while improving transparency and reproducibility.

Learn how HARPER was developed, where its strengths and limitations lie, and how broader adoption could strengthen the evidence used by regulators, payers, clinicians, and other healthcare decision makers.