HARmonized Protocol to Enhance Reproducibility (HARPER): An ISPE-ISPOR Joint Task Force of the RWE Initiative

Background: Problem: Ambiguity in communication of key study parameters limits the utility of RWD studies in healthcare decision-making. Clear communication about data provenance, design, analysis and implementation is needed. This would facilitate reproducibility, replication in independent data, and assessment of potential sources of bias.

What we did: The International Society of Pharmacoepidemiology (ISPE) and International Society of Pharmacoeconomics and Outcomes Research (ISPOR) convened a joint task force, including representation from key international stakeholders, to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. The template builds on existing efforts to improve transparency and incorporates recent insights regarding the level of detail needed to enable RWE study reproducibility. The overarching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters, two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility.

The template provides a set of core recommendations for clear and reproducible RWD study protocols and is intended to be used as a backbone throughout the research process from developing a valid study protocol, to registration, through implementation and reporting on those implementation decisions.

Recognizing that the impact of this harmonized template relies on dissemination and adoption, the task force has outlined a strategy to introduce and pilot the template with key international stakeholders over the next 2 years.

Objectives: 1. To introduce HARPER to the wider ISPE/ISPOR membership
2. To solicit testing, use, and feedback on of HARPER from ISPE/ISPOR members
3. To encourage greater transparency and reproducibility of RWD studies

Researchers and decision-makers using RWE would benefit from attending this symposium.

Description: This symposium will introduce the HARPER harmonized protocol template for RWD studies and the rationale for developing it (15 min Dr. Wang). Dr. Arlett, Dr. Rivera, and Dr. Goettsch will provide regulatory and HTA perspectives on why these developments are important and place them into context (30 min). As moderator, Dr. Crown will discuss next steps and lead the Q & A (25 min).