Updated Insights Into The Current Financial Impact
The Tufts Center for the Study of Drug Development (CSDD) recently published a study providing deeper insights into the current financial impact of delays in clinical trials. The study, led by Ken Getz, MBA, revealed that the long-standing estimate of $4 million per day of delay in drug development is significantly overstated. According to the new research, the actual cost is approximately $500,000 per day in unrealized drug sales, with direct daily clinical trial costs averaging around $40,000.
Key Findings from the Tufts CSDD Study
- Inaccurate Old Estimates: The frequently cited $4 million per day figure was based on data from the 1990s and is now considered vastly overestimated. The actual value of lost daily sales is closer to $500,000, with variations across therapeutic areas.
- Declining Value Over Time: The study found that the average daily sales value has been decreasing by $80,000 to $100,000 annually. This decline reflects a shift towards more targeted therapies for smaller patient populations, including rare and ultra-rare diseases.
- Cost of Clinical Trial Delays: Direct costs of conducting clinical trials also vary by phase, with Phase III trials being the most expensive at approximately $55,716 per day. The study suggests that the cost structure of clinical trials has evolved, with certain direct costs potentially being lower today than in the past.
For a detailed exploration of these findings, you can refer to the full article in Applied Clinical Trials, June 2024, Vol. 33, Issue 6 (Applied Clinical Trials) (Tufts CSDD) (SpringerLink) (BioWorld).
Insights from Johann Proeve, PhD, Chief Scientific Officer
Johann Proeve, PhD, Chief Scientific Officer at Cyntegrity, comments, “The Tufts CSDD study confirms the accuracy of our Clinical Monitoring Cost Savings Calculator. Our tool, based on real-world data and extensive use case experience, provides valuable insights into potential cost savings. The study underscores the importance of adopting a realistic, data-driven approach. By integrating RBQM and QbD with critical thinking, clinical trials become more predictable and efficient, helping manage costs more effectively.”
Insights from Anastasia Shapovalova, MSc, Head of Centralized Monitoring and Analytics
Anastasia Shapovalova, MSc, Head of Centralized Monitoring and Analytics at Cyntegrity, adds, “Live monitoring of processes, such as in clinical trials or studies, offers numerous advantages. It comprehensively explains key process performance indicators and systemic issues in protocol design. Additionally, it enhances the effectiveness of mitigation and corrective actions. Risk-Based Quality Management goes beyond risk assessment; it involves understanding what is crucial for your project, identifying issues as early as possible, and managing them effectively. Integrating RBQM deeply into study management helps to uncover universal solutions, identify systemic errors, and avoid or minimize these issues (including but not limited to study delay and potential sales loss) in future projects.”
Explore Our Calculator
The Clinical Monitoring Cost Savings Calculator, launched in March 2024, leverages AI and risk-based methodologies to offer actionable insights into cost-saving opportunities. To see how it can reveal potential realistic savings, and so optimize your clinical trial processes based on your specific study data, visit the Clinical Monitoring Cost Savings Calculator introduction page.
Why RBQM and QbD Matter
The Tufts CSDD findings highlight the need for risk-based and quality-by-design (QbD) approaches in clinical trials. As financial stakes rise and markets shift towards specialized therapies, employing these strategies with critical thinking enhances predictability and streamlines operations.
At Cyntegrity, we are committed to helping clients achieve operational excellence through our RBQM tools, including the Clinical Monitoring Cost Savings Calculator. Visit our MyRBQM Portal to discover more about our solutions and how we can refine your clinical trial processes.
This blog post synthesizes recent academic research and industry insights, underscoring the relevance of advanced clinical trial management techniques. By staying at the forefront of innovation, we aim to empower our clients to navigate the complexities of drug development with confidence.
