Innovation in clinical trials historically has been slow, and people often point to regulations and regulators as the reason. But are regulators truly the bottleneck?
In this webinar, Jonathan Andrus makes the argument that regulators are actually a driving force behind innovation. Tune in to see examples across the clinical trials process where regulators are not only supporting but encouraging innovation, including:
- Study design — requesting patient input on protocols, using novel trial designs that reduce patient burden, advancing risk-based approaches
- Study conduct — risk-based approaches to monitoring and study oversight, use of real-world evidence
- Post-study — faster approvals and adaptive pathways, early access to promising treatments, expanded use of post-market surveillance
Internal quality assurance (QA) and regulatory teams can be a hold-up when they rely on historical practices and personal preference rather than current regulatory guidance in assessing the feasibility and risks of implementing new and innovative solutions to clinical trial challenges. It’s time for sponsors, contract research organizations (CROs) and technology vendors to step up and join the evolution of clinical data management to data science — a strategic discipline enabling the execution of complex protocol designs in a patient-centric, data-driven and risk-based approach to ensuring subject protection as well as the validity of trial results.