How Clinical Data Layers Impact How Patient Availability is Determined

One of FDA’s main focuses at the moment is streamlining the drug approval process. In June of this year, the agency announced a new pilot program designed specifically to shorten the early-stage drug trial timelines.

A key factor of this is the growing acceptance of RWD in trial design. The agency hopes that by allowing RWD collected by qualified research institutions, drug developers will not only be able to move through early stages faster, but also reduce the need for late-stage trials as well.

Pharmaceutical Executive spoke with Jen Lamppa, SVP of commercial strategy, how RWD impacts trial design, specifically during the patient eligibility screening phase. The addition of this data is expected to impact recruitment timelines, although it may have other unintended impacts as well. As such, pharma and biotech companies will likely need to adjust their recruitment models to properly take advantage of the new environment.

Pharmaceutical Executive: How do clinical data layers impact how patient availability is determined?
Jen Lamppa: Clinical and administrative data layers are a powerful way to validate what a patient is self-reporting — and to reduce the burden placed on the patient in the first place. Using real-time, patient-specific data feeds, you can get an immediate read on diagnoses, current medications, health status, and prior health history before or at the point of enrollment.

That capability improves the accuracy of the information being collected and strengthens the validation process. It adds a layer of refinement not just to who you are reaching out to, but to what information you choose to ingest on a patient and how you verify it — creating a more reliable foundation for the entire enrollment process.