Aetion is honored to be represented at ISPOR, the leading global event for health economics and outcomes research. Our scientific experts will be onsite to share their work throughout the conference programming in a number of live presentations and posters, as well as on the exhibit floor.
Visit us at Booth 1106 where our A-Team of RWE specialists will be on hand to answer questions about our suite of scientific services and offer demos of our best-in-class RWE analytics tools.
The focus on using real-world evidence (RWE) in regulatory and HTA/payer decision-making has often centered on complex and nuanced use cases like external control arms and comparative effectiveness studies. However, the acceptability of these use cases in decision-making are generally infrequent and involves rare and deadly diseases. While there is a push to advance RWE to more complex use cases (e.g., comparative effectiveness), we often overlook the value of robust descriptive RWE studies to inform clinical development and commercialization. In our experience, the industry often does these RWE studies piecemeal, too late, or not at all. This session will outline a systematic phased approach for RWE investment that is critical for decision-making and the headwinds that arise when companies do not do their critical RWE “homework”.
Oncology Trial Emulation Using Real-World Electronic Health Record Data: Results of the Coalition to Advance Real-World Evidence Through Randomized Controlled Trial Emulation (CARE) Initiative
Addressing Information Bias in Electronic Health Records and Claims Data: What Can the Literature Tell Us and How Should We Respond?
Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. However, information bias (i.e., measurement error, variable and outcome misclassification) can hinder the effective use of RWD. It is thus important for researchers to understand how information bias can impact the validity of RWE and work to mitigate it in their studies. This workshop will provide an overview of information bias in RWD studies, with a focus on electronic health records (EHR) and claims data. Participants will learn about current strategies for information bias mitigation and potential paths forward for best practices.
Real-world evidence (RWE) is increasingly evaluated for regulatory and reimbursement decisions regarding medical devices. While numerous RWE guidance documents have been published, what constitutes “fit-for-purpose (FFP)” or “fitness for use” of real-world data (RWD) in generating RWE to inform decisions remains uncertain. Moreover, most guidance fails to differentiate between RWE for pharmaceuticals and devices. There are differences in what can be observed between pharmaceuticals and devices in RWD and in the decision making due to varying regulatory pathways and benefit\risk and value assessments. There are also differences in ability to demonstrate data is FFP by device type and data source. Often, devices are only identifiable at a class level in claims data; clinical information may be missing even within EHRs; privacy considerations may limit data validation. However, these data are valuable for RWE generation for numerous reasons like sample size and follow-up duration. This session will compare regulator, HTA, and US payers’ perspectives on demonstrating secondary RWD are FFP for regulatory and payer decision-making for devices.
Aetion is a healthcare technology company that provides decision-grade real-world evidence solutions to biopharma companies, payers, and regulatory agencies. Learn more at aetion.com.
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