Hybrid Studies: A Foundation For Comprehensive Evidence Development
Executive Summary
Hybrid studies, which integrate prospective and existing health data, can generate evidence of drug and device safety and effectiveness through long-term patient follow-up in real-world settings.
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A New Framework For Comprehensive Evidence Development
In today’s health care environment, where the volume and complexity of clinical information continues to increase for a range of stakeholders, research sponsors must understand how clinical trials, prospective observational research or registries, and retrospective data are used, what the costs are, and what a combined approach will look like. They must prepare for a more comprehensive and efficient research paradigm that provides payors, providers, and policy makers with the requisite data to make coverage and treatment decisions.
Using Enriched Studies For Post-Approval Evidence Needs
These days, clinical trial sponsors are being asked to provide empirical evidence to many stakeholders with diverse needs and to do so efficiently. By taking a holistic view of post-approval evidence needs, it is possible to address many stakeholders’ needs, thereby minimizing expense while increasing the likelihood of getting data that are fit for a variety of purposes.
Engaging And Retaining Patients In Long-Term Observational Studies
Success of long-term observational research studies depends on retaining participants; patient drop-out can lead to loss of vital data including endpoints. Study design considerations and direct-to-patient engagement strategies can help pharmas improve retention and compliance.