Abstract
To improve efficiency in clinical research and development (CR&D), sponsors alter procedures or technologies, sometimes without measuring the impact of such changes. To evaluate the effects of procedural and technological changes, we proposed to objectively measure efficiency within Searle's department of CR&D. Efficiency was defined as output/input per fiscal year. Considering financial investment and people as fundamental inputs, we identified a small number of key outputs. Using data from the preceding three fiscal years, we determined the most important indices of efficiency to be (a) the sum of (protocols initiated + reports written) per person; (b) average total expenses per (protocol + report); (c) average clinical grant costs per center receiving drug for the first time; (d) average clinical grant costs per new protocol initiated; (e) the numbers of case report forms processed per person in CR&D worldwide; (f) the numbers of case report forms processed per person in the data handling group alone; and (g) average total expenses per case report form. Values for these seven indices have established a useful baseline. Using them, we plan to measure the effects of subsequent changes in technology, policies, and procedures on the efficiency of clinical research.
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