Effective Organization of Phase 1 Clinical Trial Sites
Phase 1 clinical trials are the first set of tests conducted on human subjects. These tests are performed to assess the safety, tolerability, and pharmacological properties of an administered drug. Phase 1 Trial Sites (P1TSs) are clinical drug/treatment performance sites that provide a common infrastructure for conducting several different trials simultaneously. Approximately 75 new trials are initiated each day around the world. Current trial practices rely on limited databases, word of mouth, balkanized planning processes, and narrow field experience. A decision support system (DSS), which is a computer-based information system that supports business or organizational decision-making activities, can be used to efficiently improve financial and scientific values derived from a P1TS. Such a system will also rationalize the management to better incorporate strategic decisions, and provide risk management through improved analytics and forecasting of the costs and overtime of a P1TS.
Clinical Trial Site Decision Support Software
CApacity Planning Tools and INformatics (CAPTAIN) is software that uses statistical, mathematical, queuing, optimization, computer science, and other engineering methods to transform current P1TS practices. CAPTAIN provides decision support functionality for (1) forecasting and quantifying key site metrics, (2) selecting of which trials to conduct as a portfolio and which ones to decline, and (3) capacity expansion planning (rooms/chairs and staff (including the skills they would possess). The system emphasizes three critical site metrics: (1) Time to first treatment/visit (TTFT) measured as the time a participant wishes to be enrolled and earliest available appointment; (2) Target Workload Deviation (TWD) from desired utilization levels for room/chair resources and nursing staff; and (3) Financial Value Gained (FVG) by conducting the selected portfolio of trials in the portfolio. CAPTAIN employs novel queuing approximations of TTFT in a multi-objective Math Programming optimization model.
Applications and Advantages
- Phase 1 clinical trial decision support system
- Increased awareness of P1TS resources
- Improved financial and scientific value of trials
- Better strategic decisions
- Decreased costs