Many clinical research professionals are RBM believers, convinced that a risk-based approach to monitoring represents an effective and more efficient alternative to the tradition of frequent on-site visits and 100% SDV. Many others are cautiously open to the idea, and are waiting for news of successful RBM studies to start filling the industry journals and online forums. From those same journals and forums, we know that RBM studies have been, and are currently being, conducted. In collaboration with CluePoints, GSK Vaccines is piloting a central statistical monitoring approach. Sanofi and Lilly are currently piloting the TransCelerate methodology published in May. Bayer and other sponsors are using an analysis of EDC data and metadata to steer their on-site monitoring activities. Many CROs are offering their sponsor clients alternative monitoring solutions; Quintiles has conducted upwards of 60 studies using a number of different RBM implementations, Health Decisions has had years of experience conducting trials using its adaptive monitoring approach, and ICON has just announced its ICONIK Monitoring service after several years of piloting it alongside the traditional approach. Finally, almost every RBM webinar (RBM-inar?) I’ve attended has mentioned that government and academic clinical trials commonly employ a RBM strategy.
But it’s been quiet. The big headlines necessary to assuage lingering doubts have not been forthcoming. Even as we begin to hear about RBM successes, how will we know if RBM is as good as traditional techniques?
