A7 – Risk-Based Monitoring – A forum to review changes in monitoring practices, SDV and technology

Synopsis: Enhanced monitoring practices aimed at improving efficiencies in clinical trials have seen steady but slow progress over the past decade. Recent encouragement from regulators and consensus from industry that efficient, cost-effective practices must be adopted, are increasing the momentum of change.  Sites are also focussing on the need to assess their processes and infrastructure to support such changes. This session provides a forum to review and discuss local developments in RBM and SDV processes from all perspectives. It also provides an update on global technologies aiding that process.

Abstract: Achieving efficient, cost-effective monitoring practices in clinical trials is a compelling objective for both sponsors and investigator sites. For over a decade, Risk Based Monitoring (RBM) has been an elusive target. Academic research has identified the theoretical and statistical feasibility of modifying source data verification (SDV) sampling plans to achieve targeted, trial specific practices to return better results and more efficient monitoring. Converging factors are further encouraging adoption of these techniques. Real-world experience with RBM and selective SDV has gradually increased over recent years with the FDA’s 2013 “Guidance for Industry” endorsing RBM practices and driving more rapid adoption. Underpinning this change have been enhancements in technology, including Electronic Data Capture (EDC), facilitating a more sophisticated and granular approach to SDV; while internet access, data standardisation and data security are further enabling automated data uploads and remote access to relevant hospital patient records and laboratory results. The urgent need for industry to realise efficiencies, reduce redundancy and speed-up clinical trials, while maintaining or improving safety compliance, has forced alliances between sponsors and partners, such as the TransCelerate initiative. With this evolution, the uptake of RBM is rapidly expanding across trials in diverse therapeutic areas and geographies, to the point where it is now a standard topic on the agenda of most international conferences – indeed, conferences dedicated solely to this topic are increasingly common.  This session will provide an update on local and international current best practice in RBM and SDV methodologies from the perspectives of sponsors, CROs, site staff and technology suppliers, including clinical trial case study experiences.

Chairperson: Dr Jon Carrano, Pharmsite