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Research Development & Clinical Trials Technology Considerations To Increasing Clinical Trial Efficiencies With Risk-Based Monitoring By Chip deVillafranca and Jonathan Andrus W hen it comes to site monitoring, pharmaceutical companies have traditionally taken a conservative approach, performing frequent on-site monitoring and 100 percent verification of all data. This practice goes beyond what's required, says the FDA in its Guidance for Industry: Oversight of Clinical Investigations — Risk-Based Approach to Monitoring, issued in August 2013. The agency asserts that sponsors adopted current practices based on a "perception" that 100 percent source data verification (SDV) was the FDA's preferred way to meet monitoring obligations. Now it is trying to change that perception, citing academic- and government-sponsored research that has been successfully completed with less extensive on-site monitoring methods. The agency suggests monitoring strategies with a modern, risk-based approach and encourages greater use of off-site and central monitoring that employs technological advances in replacement of 100 percent SDV. TransCelerate BioPharma, Inc. is helping to drive and speed adoption of this approach, making it the first of five key initiatives aimed at improving clinical trial efficiencies. Its Risk-Based Monitoring Methodology position paper issued in May states, "Current operational practices used in clinical trials are expensive and do not guarantee data quality." The consortium points to modernization utilizing technology enablers that create efficiencies without impacting subject safety. Both the FDA and TransCelerate suggest making this change allows 44 LifeScienceLeader.com a shift in focus from manual aspects of data quality to what's really important: patient safety, endpoints, informed consent, drug management, protocol training, and other study aspects. In the current model, estimated costs for on-site monitoring with 100 percent SDV range between 20 and 30 percent of total study costs. A significant amount of the monitor's time is spent checking for data entry errors, when in reality the FDA is looking at the overall data quality plan, not at every data element. Previous studies have shown that only 2.4 percent of data corrections occur as a result of SDV. With appropriate metrics and remote-review techniques, reduced verification can be employed with no loss of data quality. TECHNOLOGY CONSIDERATIONS Comprehensive risk-driven approaches rely on visibility into clinical data and operational key performance indicators to enable centralized review and monitoring. An electronic data capture (EDC) solution that captures site activity and clinical data in real time is essential, but this must be integrated with metrics from a clinical trial management system (CTMS). Achieving a holistic view of clinical sites, both past and present performance, through robust reporting and analytic tools is the cornerstone of any riskbased monitoring strategy. February 2014 As sponsors rarely work with a single vendor, multiple eClinical systems are typically already in place. Before a new monitoring approach can be implemented, an organization must ask: "Are we able to get the data out of where it is and into an analytic system to review and act on it?" Sponsors will need the ability to view data from across all systems, such as site initiation, document approvals, subject enrollment, data capture metrics, protocol deviations, adverse events, timeliness, and staff turnover — essentially all study activity. A system's location is immaterial as the Internet allows it to be located anywhere, whether cloud-based, on-site, or elsewhere. However, the APIs and interfaces are critical. Shifting to a strategic risk-based approach hinges on having immediate access to clinical and operational data, both current and historic. Continual assessment of data over the life of the study will indicate whether the site-monitoring plan needs adjustment. WHAT'S YOUR DATA TELLING YOU? Centralized monitoring allows monitors to see patterns and detect problems early. It helps them to identify whether something is meaningful and requires action, such as when a protocol change is needed or a site needs extra support. Consider the example where a monitor is looking at 100 sites and