State of Digital Clinical Trials Podcast Is a Heavy Tech Burden the Price of Progress for Sites?
Oct 31, 2024
Brad Hightower, owner of Hightower Clinical, dives into the challenges of balancing technology with clinical trial efficiency. He discusses whether the increasing tech burden is justified for progress and shares insights on how sponsors can ease site operations. The conversation highlights the implications of recent FDA guidance on decentralized trials and the importance of fostering communication between sites and sponsors. Brad also teases the upcoming ‘Save Our Sites’ conference aimed at revolutionizing site support.
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Improve eCRF Guidelines
- Sponsors should provide clear, detailed eCRF guidelines to help sites build accurate electronic source documents.
- Good guidelines reduce ambiguity and ease data collection for coordinators, improving data quality.
Streamline Source and CRF Entry
- There’s confusion about the difference between source documents and case report forms (CRFs), leading to redundant work for sites.
- FDA permits direct EDC entry, which could streamline data collection but remains underutilized.
Data Aggregation Challenges at Sites
- Sites aggregate data from multiple sources including multiple providers and external records into binders or eSource systems.
- Decentralization and varied digital tools complicate data aggregation and PI review, increasing site workload.