Broader populations, real-world endpoints, community-based sites, remote data capture, and commercially driven timelines — all in the same protocol. That is the brief for post-approval respiratory studies right now, and the operational demands are distinct from pivotal trial delivery.

These studies require faster recruitment across more representative populations — older, comorbid, polypharmacy, and mobility-limited patients in community as well as academic settings. They require capturing endpoints such as ED visits, hospitalisations, steroid burden, and treatment persistence with payor-grade rigour and consistency over time. And when protocols incorporate remote diagnostics — such as validated home spirometry — that expands who can be enrolled (including patients who cannot attend regular clinic visits) while adding device deployment, patient training, and remote data quality management to the operational scope.

Where site-only models are reaching their limits on speed and population representativeness, the operational model needs to adapt. In this webinar, panelists from across pharma, managed care, academic medicine, and clinical operations discuss how respiratory programmes are building execution frameworks for these studies.

Why This Matters Now

• Recruitment timelines are the critical path to launch — delays in post-approval studies directly affect commercial positioning
• Sponsors are commissioning studies with broader, more diverse populations that site-only models were not built to reach at speed
• Remote diagnostics expand who can be enrolled but add operational complexity that needs to be planned for upfront
• Evidence that lacks rigour or representativeness is increasingly unlikely to influence coverage decisions — the execution bar is rising

What You’ll Hear

How respiratory programmes are:

• Accelerating recruitment timelines through decentralised and hybrid models that reach broader populations across community and academic settings
• Enrolling older, comorbid, and mobility-limited patients who cannot attend regular clinic visits — and managing the site and data implications of that
• Deploying remote spirometry (e.g. GoSpiro) to capture consistent, diagnostic-grade respiratory data from both mobile and immobile patients at home and in community settings — and what that means for device logistics, patient training, and data quality management
• Maintaining payor-grade data consistency and rigour across distributed sites and remote data streams
• Structuring the operational model — site activation, enrolment, and data capture — to hit milestones on commercially relevant timelines

What You’ll Leave With

• A practical operational framework for delivering faster, more representative respiratory Phase 3b/4 and RWE studies
• How remote spirometry deployment affects timelines, site burden, and patient compliance in practice — and how to plan for it
• What separates post-approval studies that influence coverage decisions from those that do not — from a data quality and execution standpoint
• How leading teams are structuring site networks and enrolment strategies to reach diverse populations without compromising speed