Operational departments such as clinical monitoring, data management, and clinical quality assurance (CQA) track capacity and productivity by selected use of metrics (Table 2). Clinical project management or clinical operations collects project metrics from every clinical trial conducted. A variety of so-called "micro benchmarks" are available for scrutiny as outlined in Table 1B.

Table 5. Construction of three proposed trial scenarios based on actual past performance metrics

Study site metrics keep track of critical steps and/or elements at the source of clinical data generation. Both sites and study sponsor benefit from the information that can be obtained from the metrics shown in Table 3.

CROs, as highly important contributors to today's development output, use operational metrics that match those of their customers. Certain pharma companies make cycle times track records a prerequisite for contracting with a CRO^8,9—both quality and productivity performance are of utmost relevance to the prospective customer. In addition, CROs use utilization (refer to Table 2) more consistently as departmental metric than pharma does. The metric realization compares the achieved to the contracted revenue. Other, more sophisticated calculations are used as well. High productivity and quality must translate into profitability of their endeavors, should their development business remain viable.

Outsourcing performance metrics, such as indicators of the efficiency and productivity of the cooperation between sponsors and CROs, seems to be the logical missing link in the clinical development production chain these days. Selected time periods and other indicative metrics of potential value¹⁰ are displayed in Table 4.

How to launch and maintain a metrics system Senior management must demand and drive improvement of clinical development productivity, and its transparency to all hierarchy levels. Current processes, tools, resource utilization, and clinical trial tracking systems have to be evaluated for effectiveness. Gross performance deviations from industry standards should be addressed as first priority.

Operational task forces develop the principles of the new system via either an independent in-house manager or an external consultant. The information technology (IT) department has to be represented in the task force.

Once the direction is identified and agreed to, IT should receive the funds to set up a new performance metrics database. The data for this database usually derive from sources originally set up and maintained for other purposes—clinical trial management system, human resource database, project finance tracking system. This avoids duplication of data entry efforts. Headcount is allocated to oversee the generation of management reports, and to analyze, interpret, and summarize the findings across the organization. This staff also assumes responsibility for the benchmarking of the internal progress in the light of best industry practices.

The various department heads receive reports and share the key conclusions with their staff. Achievements are the basis for periodic assessments for further improvement at the departmental level. Department heads and their staff work toward and agree on new performance targets. Functional departments assume ownership of "their" performance metrics and continually strive towards optimization without fear of unreasonable pressure and personal punishment. The development staff obtains this information in the context of the "big picture" of the company's R&D efforts. This includes time spent for go/no-go decisions at the management level between cycle times, and of the fundamentals of the entire business performance in a "digestible" format.

Collected project metrics are used as required by new development programs on the horizon. As a principle, only experience in the same indication and of similar country distribution is used for reference purpose. And that has to be substantiated by newly set-up feasibility surveys.