TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT

Sponsors seeking favorable venues for cardiovascular trials must consider disease prevalence and access to treatment-naïve patient populations; regulatory environments regarding ICH-GCP standards and the availability of expert cardiovascular investigators; and clinical trial operations, including study approval timelines, clinical supply processes, and availability of technology platforms. Technology Trends: Electronic Platforms, Real-time Data, Risk-based Monitoring The increasing trial size and complexity makes advanced technology platforms essential to improve efficiencies in global cardiovascular development. Electronic data capture (EDC) enables rapid data collection and sharing in multinational trials that must manage huge patient databases across multiple international study sites. Two current trends have special importance in cardiovascular research: platforms that support real-time data access; and automated systems to manage endpoint adjudication. Access to real-time data is central to advanced approaches in clinical monitoring. A 2005 study of Phase III costs in cardiovascular trials reported that site monitoring accounted for 25 percent to 30 percent of trial costs. 26 The high-cost, traditional model of onsite visits every four to eight weeks and 100 percent source document verification is gradually giving way to risk-based monitoring approaches that supplement onsite visits with various levels of remote (centralized) and targeted monitoring to focus on the data most critical to study outcomes. The 2011 FDA guidance on trial oversight encourages greater reliance on automated, remote monitoring practices as a means to improve data quality and ensure subject protection. 27 EDC platforms together provide the means for remote monitoring by centralized monitors; with real-time data access facilitates triggered monitoring that alerts monitors to safety and data quality issues. Web-based automated systems are essential for timely and efficient endpoint review by adjudication committees. Online access to patient records and event dossiers speeds the review process, potentially eliminating the need for face-to-

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