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Int. J. Environ. Res. Public Health 2014, 11(5), 5069-5080; doi:10.3390/ijerph110505069

Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance

Center for the Study of Drug Development, School of Medicine, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA
Received: 20 February 2014 / Revised: 29 April 2014 / Accepted: 30 April 2014 / Published: 12 May 2014
(This article belongs to the Special Issue Economics of New Drug Development and Approval)
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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. View Full-Text
Keywords: protocol design complexity; protocol amendments; extraneous protocol procedures; direct drug development costs; indirect drug development costs; protocol feasibility protocol design complexity; protocol amendments; extraneous protocol procedures; direct drug development costs; indirect drug development costs; protocol feasibility
This is an open access article distributed under the Creative Commons Attribution License (CC BY 3.0).

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MDPI and ACS Style

Getz, K. Improving Protocol Design Feasibility to Drive Drug Development Economics and Performance. Int. J. Environ. Res. Public Health 2014, 11, 5069-5080.

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