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Page 410 C. Reduced Reporting Time Barnett and James [6] have examined the overall performance of the clinical trial cycle time by examining the time taken to complete the 6 stages of the trial cycle: protocol writing, trial start-up, subject enrollment, data cleaning, analysis, and report writing. The average total cycle time for the 1,000 clinical trials surveyedfrom protocol start to approval of the final study reportwas more than 200 weeks (3 years, 10 months). Although it is commonly believed that the cycle time is affected by the phase of the clinical trial, the authors found very little difference in cycle times between Phase I, Phase II, and Phase III trials. Aside from the differences in patient enrollment times, the other processes took roughly the same amount of time in each phase. What was more surprising was the observation that the completion of the three final stages (i.e., data cleaning, analysis, and reporting) took an average of 47, 16, and 44 weeks, respectively, almost as long as the subject enrollment stage. Since the reporting of clinical trials is, in most cases, on the critical path for the successful and speedy submission of an MAA regulatory package, the duration of the final three stages in Barnett and James' survey appear excessively long. A similar performance measure has been defined for Zeneca clinical trials. The interval between the Last Patient Completing the Protocol and the Completion of the Statistical Evaluation of the Trial (i.e., the data cleaning and the analysis stages combined) have been determined and are presented in Table 5 and Figure 10. For multicenter trials completed since 1991, the median interval between patient complete and statistics complete was 22 weeks for trials where the clinical pathology was performed at local laboratories and 12.5 weeks where the trials were supported by Zeneca's laboratory. Table 5 Overall Duration Between Last Patient Complete and Statistics Complete Zeneca Central Laboratory Outside Laboratories Indication N Median Mean SE N Median Mean SE All indications 20 12.5 14.22 3.62 49 22 22.96 2.58 Antiasthmatic 7 12 16.00 3.49 Anticancer 4 11 10.25 1.78 Anticancer 2 10 10.00 0.00 6 20.5 34.67 13.62 Anesthetic 7 23 25.86 7.35 Antibiotic 21 22 26.43 2.98 Anticancer 9 22 20.44 2.65 Cardiovascular 3 18 17.33 0.98 Cardiovascular 2 16.5 16.50 3.18 Anticancer 2 13 13.00 0.71 6 18 22.00 4.68 Data for multicenter trials with Regulatory Phase compounds for trials completed after 1991.
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