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. 2014 May 12;11(5):5069-80.
doi: 10.3390/ijerph110505069.

Improving protocol design feasibility to drive drug development economics and performance

Kenneth Getz  1
Affiliations

Improving protocol design feasibility to drive drug development economics and performance

Kenneth Getz. Int J Environ Res Public Health. .

Abstract

Protocol design complexity has increased substantially during the past decade and this in turn has adversely impacted drug development economics and performance. This article reviews the results of two major Tufts Center for the Study of Drug Development studies quantifying the direct cost of conducting less essential and unnecessary protocol procedures and of implementing amendments to protocol designs. Indirect costs including personnel time, work load and cycle time delays associated with complex protocol designs are also discussed. The author concludes with an overview of steps that research sponsors are taking to improve protocol design feasibility.

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Figures

Figure 1
Figure 1
Proportion of protocol amendments occurring before the patient has received the first dose.
Figure 2
Figure 2
10-year overall growth (2002–2012) in total procedures and work burden per protocol by phase.
See this image and copyright information in PMC

References

    1. Getz K.A., Kim J., Stergiopoulos S., Kaitin K.I. New governance mechanisms to optimize protocol design. Ther. Innovat. Regul. Sci. 2013;47:651–655. doi: 10.1177/2168479013494386. - DOI - PubMed
    1. Getz K., Stergiopoulos S., Marlborough M., Whitehall J., Curran M., Kaitin K. Quantifying the magnitude and cost of collecting extraneous protocol data. Amer. J. Ther. 2013 doi: 10.1097/MJT.0b013e31826fc4aa. - DOI - PubMed
    1. Getz K., Zuckerman R., Cropp A., Hindle A., Krauss R., Kaitin K. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf. J. 2011;45:265–275.
    1. Getz K., Wenger J., Campo R., Seguine E., Kaitin K. Assessing the impact of protocol design change on clinical trial performance. Amer. J. Ther. 2008;15:449–456. - PubMed
    1. Clark T. Data is King. [(accessed on 4 May 2014)]. Available online: http://www.samedanltd.com/magazine/13/issue/173/article/3242.

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