Figure 2. Monitoring performance over a four-year period. The median number of enrolled patients for 10 countries is shown
per clinical research associate (CRA) FTE and per FTE for all staff within the entire clinical operations group.
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Suddenly, you awake. This was only a bad dream. Your team and all other operational departments did their homework a few years
ago. You introduced a performance metrics system in all operational departments, at project level, and across all countries
in which your company maintains development operations. You use metrics to track the efficiency of the cooperation with study
sites and CROs. As a result, you can easily write a study plan in line with the above specifications.
Table 3. Site-specific performance metrics
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Reasons for a performance metrics system Pharma industry associations and cooperating institutions like the Tufts Center for the Study of Drug Development and the
Centre for Medicines Research International Ltd. (CMR) maintain sophisticated systems for R&D timeline, cost, and productivity
tracking based on the input from research-based pharma companies. They generate benchmarks for development of new medicines,
as well as their relationship to output in terms of new active substances (NAS) that obtain marketing authorization.
Disproportion of development time/cost and number of new product launches. Total development time from preclinical testing to marketing authorization increased from 8.8 to 13.9 years between the 1960s
and the 1990s.1 Of 5000 screened compounds, only five reach Phase I of clinical development. Ultimately, one NAS obtains a marketing license.2 The latest estimate puts the average R&D cost for one NAS reaching the market at $802 million. This translates into an almost
six-fold increase between 1975 and 2000.3 This is also reflected in the dramatic increase in the annual global pharmaceutical R&D expenditure, which more than doubled
between 1990 and 2000, from about $20 to 43 billion. Disappointingly, the output in terms of annual NAS marketing authorizations
reached an all-time low of 26 in 2003.4
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