The Future Of Clinical Trial Oversight

The future of clinical trial oversight is being shaped by the increasing use of decentralized trials, which in recent years, have proven to have several advantages over traditional clinical trials, including improved patient recruitment and retention, reduced costs, and faster time to market. However, the DCT approach requires a reevaluation of data management and trial oversight to ensure quality and patient safety. This task involves the support of source data verification, source document review, on-site monitoring, remote monitoring, centralized statistical monitoring, and risk assessment and monitoring.

To address these needs and the new challenges presented by this style of study, regulators and industry stakeholders are working to develop new standards and best practices for decentralized clinical trials. Comprehensive risk assessments are the first step in oversight activities when identifying crucial data and processes and starting on-site study start-up activities.

Discover how digital technology can be leveraged to enable a flexible approach to monitoring in today’s era of DCTs.