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W-04: Reducing the Cost of Systematic Risk Assessments of Medical Products by Using a Modular Learning Risk Repository System

Poster Presenter

Stephen Sun

Vice President and Head of Quality Risk Management
Syneos Health
United States

Objectives

To develop a cost-efficient method for performing systematic risk assessments of regulated medical products in near-real time as part of a research collaboration with the FDA.

Method

Costs to sponsors for a facilitated session of a comprehensive risk assessment for peri-approved regulated medical products ranged from $150,000 to $200,000 and is a rate-limiter for wider adoption. A modular digital risk repository software was developed and used in 100+ clinical study protocols.

Results

Within a period of more than two years, a software system with a modular digital library of risks and preventions was developed to output a systematic risk assessment in near real-time. Upon completing the review of a Sponsor’s clinical study outline or protocol, one of the three staff members of the quality risk management team would select from the library the relevant risks and preventions, tailor the content to any product-specific or study design-specific parameters, and seek concurrence of the information internally before delivering the final output to the respective study team. In this period, the speed for performing risk assessments of clinical study protocol and concept sheets reduced billing costs for sponsors from approximately $150,000 - $200,000 to $8,000 - $12,000 for performing a risk assessment for a clinical study protocol (also known as a Preliminary Risk Evaluation). Actual time and cost was largely a function of the team’s reading time of the protocol and/or any other materials provided by the Sponsor and the team’s discussion and review of the near final draft; whereas the actual selection of the appropriate risks and preventions from the risk repository and tailoring the content to align with the protocol was minor. Since each successive study outline or final protocol after analysis by our quality risk management team resulted in contributing additional risks and preventions to the risk repository system, this was noted to be a continuous learning system. This method further expedited the process of each successive study when the risk and prevention was already in the library, instead of de novo development, and subsequent analysis benefited from the lessons learned of those performed before it.

Conclusion

Based upon this construct of an adaptive and modular digital library, a comprehensive assessment of risks and preventions could be generated and accessed in near real-time for an innumerable combination of component factors that may involve the design or process of a clinical study and/or stakeholder use of a regulated medical product. In the case of clinical studies, the cost of a facilitated systematic risk assessment could be dramatically reduced by approximately 95% of project costs (from an estimated $200,000 to $10,000). To handle the gamut of clinical study designs and therapeutic area differences (as well different product formulations and indications for post-approved product use), the key step was the development of a unique software interface that was adaptable and modular and also allowed users to add to the repository real-world observations and capture new insights and expert-level. As such, the system is enabled with a continuous learning quality that is intended to get faster and smarter over time. Furthermore, risk profiles of process and design for regulated products will likely adapt, mature or vary over time. In order for the system to remain relevant, the software also accommodates for a continuously changing landscape of medical terminology, mergers and acquisitions of companies, and multiple brand and tradenames across different international areas. Additional applications for commercial projects and public health scenarios are actively being explored. The system is also being evaluated for applications for public health emergencies as part of a FDA research collaboration agreement.