Customer: Army Medical Research and Materiel Command (MRMC), Army Materiel Command (AMC), U.S. Army
(Fairfield Technologies, prime contractor)
Goal: Demonstrate the technical feasibility of building an Advanced Pharmacovigilance Tool (APT) that was robust, effective, scalable, flexible, secure, easy-to-use, and utilized open source technologies
Application:
- Demonstrate the technical feasibility of building an Advanced Pharmacovigilance Tool (APT) that was robust, effective, scalable, flexible, secure, easy-to-use, and utilized open source technologies
- Provide better force health protection capabilities for DoD, at a lower total cost of ownership
- Integrate disparate data sources in order to reduce adverse pharmacological effects among force health constituents
Challenges:
- Problem Complexity – Multivariate problem, interdependent factors, original trials not powered for rare adverse event discovery, pharmacovigilence tools and techniques still evolving
- Data Availability – Fragmented, not always accessible, “ownership vs. stewardship”
- Data Usability – Differing formats, content, structure, quality, completeness, timeliness
- Resources – Software processing, analysis, visualization tools, staffing not always sufficient, available, scalable, affordable for timely pharmacovigilence analysis and action
- Security – Human subject protections, patient privacy, HIPAA, Force Health Protection, Cyber-Security
FTI’s Approach:
During Phase I timeframe, FTI successfully built and validated a proof-of-concept Advanced Pharmacovigilance Tool, and:
- Performed extensive research and conducted a number of in-depth interviews within DOD and other organizations to identify the data sources that are critical resources in the pharmacovigilance community
- Collected and validated the research, analysis, and clinical purposes of the tool.
FTI’s long term goal is to design, build, deploy, and maintain an Advanced Pharmacovigilance Tool (APT) for the U.S. Army Medical Research and Materiel Command and the Department of Defense with the following characteristics:
- Federated, integrated, self-building, self-sustaining open source software-based repositories of clinical trial information
- Actively assists researchers in rapidly identifying and evaluating accurate pharmacovigilent safety signals for drugs and vaccines being developed for Force Health Protection
- Provides targeted guidance to clinicians in the field on safety and efficacy of proposed treatments
- Provides additional support to a broad range of healthcare infrastructure functions (e.g. human research protection, quality of service evaluation, etc.)
The targeted end result is to significantly increase Force Health Protection Capabilities.
Products Used: Java, JSP, XML Pentaho Business Intelligence portal, Linux, Fedora Core, Cancer BioInformatics Grid (CaBIG), data warehouses, open source Business Intelligence frameworks, open source data analysis and visualization toolkits, passive and active search agents.
Benefits:
Better Pharmacovigilance:
- Higher-quality, more statistically-significant data and results
- More easily-identifiable safety signals
- Integrated into the current DoD patient care environment and future clinical trial design
Faster Pharmacoviglance:
- Safety signals are detected and acted on earlier because:
- The pharmacovigilance system is available and deployed earlier
- The signals themselves are detected earlier
Cheaper Pharmacovigilance:
- Minimize software licensing costs (target: $0)
- Minimize software development, deployment, operation and maintenance costs
- Leverage software investment by DoD and other organizations
Delivery: On time, within budget. Used Lean Six Sigma techniques. Formally certified as a CMMI Level 3 project.