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.
You may also be interested in...
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.
EMA could issue scientific guideline on PAES for public consultation by November.
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.