HARPER — protocol template for real-world trials for evaluating treatment efficacy
https://doi.org/10.37489/2782-3784-myrwd-23
EDN: KNEVDH
Abstract
The International Society of Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have created a joint task force, including representatives of key international stakeholders, to create a coordinated protocol template for RWE studies that assess the effect of treatment and is designed to inform decision-making. The template is based on existing transparency efforts and includes the state-of-art ideas regarding the level of detail required to ensure reproducibility of the RWE study. The underlying principle was to achieve sufficient clarity regarding research data, design, analysis and implementation to achieve the three main objectives. Firstly, to help researchers carefully consider and document the choice and justification of the key parameters of the study, secondly, to facilitate decision-making by allowing reviewers to easily assess potential bias associated with the choice, and thirdly, to ensure research reproducibility.
About the Authors
S. M. Mukhina
FSBEI HE I. P. Pavlov SPbSMU MOH
Russian Federation
Russian Federation
Mukhina Sofia M. — Resident of the department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
M. I. Baranova
FSBEI HE I. P. Pavlov SPbSMU MOH
Russian Federation
Russian Federation
Baranova Marina I. — assistant of the department of Clinical Pharmacology and Evidence-Based Medicine
St. Petersburg
Yu. E. Balykina
Saint Petersburg State University
Russian Federation
Russian Federation
Balykina Yulia E. — Candidate of Physical and Mathematical Sciences, Associate Professor of the Department of Mathematical Modeling of Energy Systems
St. Petersburg
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Review
For citations:
Mukhina S.M., Baranova M.I., Balykina Yu.E. HARPER — protocol template for real-world trials for evaluating treatment efficacy. Real-World Data & Evidence. 2022;2(4):17-25. (In Russ.) https://doi.org/10.37489/2782-3784-myrwd-23. EDN: KNEVDH
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