Hybrid Studies: A Foundation For Comprehensive Evidence Development
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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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.
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.
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.