![]() ![]() 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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