HARPER vs STaRT-RWE: Which Template Should You Actually Use in 2026?

protocolsreporting

HARPER (2023) is a harmonized protocol template from a joint ISPE/ISPOR task force. STaRT-RWE (BMJ 2021) is a structured template developed by a public-private consortium to plan and report real-world evidence implementation. They are routinely confused, and they should not be: one structures the protocol backbone, the other structures implementation reporting.[1,2]

For most new-user comparative studies we now start with HARPER tables for the SAP and then map to STaRT-RWE for the final report. Both map directly onto target trial components, which is exactly why they work.

If you only adopt one, adopt HARPER. A good protocol makes the report almost write itself. The reverse is not true.

References

Wang SV, Pottegård A, Crown W, et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects. Pharmacoepidemiol Drug Saf. 2023;32(1):44-55 doi.org/10.1002/pds.5507
Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies. BMJ. 2021;372:m4856 doi.org/10.1136/bmj.m4856
ISPOR. Real-World Evidence Registry and Transparency Initiative www.ispor.org/strategic-initiatives/topics/real-world-evidence/real-world-evidence-registry