Paying attention to key performance metrics will eventually reduce global clinical development times and deliver innovative treatments earlier.
Figure 3A. Expected differences in total enrollment duration for three scenarios based on the companys actual metrics data.
Anticipated enrollment duration was calculated based on median enrollment rates (in patients/center/month) from previous trials
for the respective therapeutic area. The country selection and site numbers are shown in Table 5. Left bar: scenarios with
128, 51, and 45 sites. Right bar: All scenarios with 128 sites, showing the effect on enrollment duration. Taken from Ref.
10.
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Clinical development is the major cost driver. The duration of the clinical phases rose from 2.8 to 6.3 years between the 1960s and the 1990s.1 In 1997 and 1998, the mean duration of clinical development of a new chemical entity (NCE) ranked at 5.4 years, down from
a maximum of 6.9 years between 1990 and 1993. For biopharmaceuticals, the mean duration was 5.2 years, the highest-ever average.
Depending on the therapeutic class, an average of 3.4 (AIDS antivirals) to 7.5 years (gastrointestinal) was spent in the period
between 1995 and 1999. Despite the high attrition rate from discovery to first use in man, clinical development absorbed 37.8%
of the total 1999 R&D expenditure.5 
Figure 3B. Estimated total monitoring visit costs for scenarios 1-3. The monitoring costs for the number of site visits were
estimated for each scenario based on the country and site numbers given in Table 5, assuming a six-week monitoring visit interval,
a six-month patient treatment period, and an average cost of 800 f per monitoring visit. Taken from Ref. 10.
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Clinical trial performance tracking by all involved players is mandatory. The workload in clinical trials is ever-increasing. Global and more stringent clinical trial regulations, maximum demands
on subject protection, documentation of processes, data quality and validity, system validation, and pharmaceutical quality
of the investigational medicinal product have been large contributors to the workload. Trial sponsors, their increasing number
of contractors, and investigational sites are all bearing equal shares in this joint endeavor. In view of this mounting complexity,
it became mandatory to track where the resources in terms of people, money, and time are spent, and which impact various measures
have on productivity and efficiency metrics over time.
Table 4. Outsourcing performance metrics
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Performance metrics used in clinical development The large stages of research and development, known as R&D macro benchmarks, are illustrated in Table 1A.
The causes for below-industry-standard performance and areas for improvement can only be identified and addressed if all contributors
to a new drug application (NDA) track those key performance metrics that they impact.
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