Regulatory agencies, health technology assessors, and payers are increasingly interested in studies that make use of real-world data (RWD) to inform regulatory and other policy or clinical decisionmaking.1, 2, 3, 4, 5 While real-world evidence (RWE) studies using rigorous methods applied to fit-for-purpose RWD can provide critical, timely insights into the safety and effectiveness6, 7, 8 of drugs, devices, and vaccines high-profile cases of studies conducted with biased methods9, 10, 11, 12 or DiscussionĪ joint task force between ISPE and ISPOR, including representation from key international stakeholders was formed to create a harmonized protocol template for RWE studies that evaluate a treatment effect and are intended to inform decision-making. One, to help investigators thoroughly consider, then document their choices and rationale for key study parameters that define the causal question (e.g., target estimand), two, to facilitate decision-making by enabling reviewers to readily assess potential for biases related to these choices, and three, to facilitate reproducibility. The over-arching principle was to reach for sufficient clarity regarding data, design, analysis, and implementation to achieve 3 main goals. 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 International Society for Pharmacoepidemiology (ISPE) and ISPOR–The Professional Society for Health Economics 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.
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January 2023
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