Importance of DCTs Moving Forward

RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.

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.

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.

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.

The new effort combines adaptive platform trial design, AI-enabled site activation, nationwide data infrastructure, and patient data contribution tools to reduce timelines, costs, and patient burden across clinical development.