Table 1A. R&D macro benchmarks
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The head of your company's clinical development department requests you to draft a project plan for a multinational Phase
III trial of 800 asthma subjects within three weeks. This plan should be quite specific regarding the number of countries
and study sites involved, the subject recruitment period, and the expected total cost of monitoring visits.
Table 1B. Micro benchmarks: Choice of clinical project cycle times and quality project metrics
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You are in a considerable dilemma. You have been opposed to implementing a proper performance metrics system. What tools should
you now use? Memory? Intuition? Best guesses? Will the development head be impressed with you at the conclusion of your project,
should this ever happen, if time and money spent exceeds your plan by as much as 100%?
Figure 1. Variance in planned versus actual recruitment. Analysis based on N=9 studies initiated in 2002. The difference (days)
between the plan as specified in the initial protocol outline and the actual recruitment period (first patient in to last
patient out) was compared. The overall median was three days ahead of plan.
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The terms "development cycle times," "performance metrics," and "benchmarking" are terms you remember well. Admittedly, you
have only superficially read some topical articles. However, being so extremely busy and not really convinced that those publications
were strictly applicable to your work situation, you did not further pursue the idea of implementing a performance metrics
system in your environment.
Table 2. Operational capacity and productivity metrics
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Despite or because of all the pressure on you, you are a solution-oriented manager. You identify quickly that the only way
to address the challenge imposed on you is to send urgent requests for proposals (RFPs) to five contract research organizations
(CROs). Your interpretation of the proposals' operational plans will allow you to deliver the project plan on time. Your best
guess of country numbers, site numbers, time needs, and resource needs depends on how many CROs respond in time, and how robust
their metrics databases and current feasibility surveys are.
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