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Research Development & Clinical Trials Strategic Approaches To Risk-Based Monitoring In Clinical Trials By John Whitaker, Ph.D., and Amy Kissam W ith drug development costs reaching between $800 million and $1.2 billion for each successful product, biopharmaceutical companies are trapped between mounting pressure to reduce development costs and the need to ensure better outcomes from clinical trials. Generics, lower approval rates, and global testing requirements are driving increases in development costs, yet outcomes remain uncertain in terms of both regulatory approval and market acceptance. In addition, large payers such as Medicare continue to exert downward pressure on prices. These shifting dynamics mean biopharms and CROs must employ a more strategic, end-toend approach to clinical trials — one that begins at the design and planning stage, is data-driven, and features workflows that direct the right resources to the right tasks, without compromising overall quality. For real change to occur, biopharms and their clinical research partners must make better use of data to plan and manage the delivery of their clinical trials. This is particularly important in the area of clinical trial monitoring, where the industry has begun to embrace a more strategic approach. The practice of riskbased monitoring is strategic in that it allocates resources across a study based on data criticality, patient safety, data integrity, protocol compliance, and impact to operational delivery. This approach starts with a risk assessment, which includes identification of core critical data that supports endpoints, patient safety, and the overall clinical development plan. 50 LifeScienceLeader.com This risk assessment then becomes the foundation for operational strategy and the initial monitoring plan. Throughout the conduct of the trial, monitoring effort is escalated and de-escalated based on key risk indicators (KRIs) and data trends. The industry, while mindful of its mission to develop better delivery models that improve quality and reduce cost, remains conservative in its adoption of new technologies and innovation in clinical trials. Sponsors still tend to tread cautiously due to the perception that new technology or process change may introduce additional risk to the regulatory or approval process. Even as regulators have more formally endorsed risk-based monitoring in recent years, industry adoption of these alternative monitoring approaches has been slow, and challenges remain in translating these concepts into effective clinical practice. THE CHANGING PERSPECTIVE The historical regulatory concern may be waning for some companies based on recent publications from regulatory authorities. In 2011, the FDA and the European Medicines Agency (EMA) issued their respective positions advocating for risk-based monitoring of clinical trials, October 2013 and have opened the door to a new industry paradigm. The FDA and EMA both acknowledge that traditional 100 percent source document verification (SDV)-based monitoring approaches are not always the most effective in ensuring adequate protection of patients and data integrity. The FDA notes that no single approach to monitoring is appropriate or necessary for every clinical trial and recommends that each sponsor design a plan that is tailored to the specific patient protection and data integrity risks of the study. In most cases, such a risk-based plan would include a mix of centralized and on-site monitoring. In its guidance, delivered in a reflection paper, the EMA says better solutions are needed to ensure that limited trial resources are best targeted to address the most important issues and priorities, especially those associated with predictable or identifiable risks to patient safety and data quality. The agency also encourages the incorporation of quality tolerance limits for the clinical trial procedures involved. These measures can direct the oversight and monitoring of patient safety, data