In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.
|Podcasts|September 3, 2021
What Strategies Should Pharma and Biotech Firms Take to Adapt to the Evolving Central Lab Landscape in Post-COVID Era
Author(s)Frontage Labs
On a global scale, Frontage Central Lab Business is assisting clients with their drug development needs across all clinical phases. In this podcast, the Frontage Central lab team will discuss some of the best practices to keep in mind when choosing a lab partner for PK/PD and routine/specialty central lab support.
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Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.
A new FDA Voices post from the agency's acting chief of staff details completed milestones and upcoming priorities across complete response letter disclosure, application lifecycle transparency, new approach methodologies, labeling, and inspectional records.
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In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
Hierarchical composite endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites, but transparent outcome prioritization, patient involvement in ranking, and reporting of Net Treatment Benefit remain underutilized despite their importance to interpretation.
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