Title: Estimating the cost of clinical innovation: parametric analysis of late stage pharmaceutical R&D

Authors: Giampiero Favato, Roger W. Mills, Bill Weinstein

Addresses: P, P&S School, Henley Management College, Greenlands, Henley-on-Thames, RG9 3AU, UK. ' P, P&S School, Henley Management College, Greenlands, Henley-on-Thames, RG9 3AU, UK. ' P, P&S School, Henley Management College, Greenlands, Henley-on-Thames, RG9 3AU, UK

Abstract: Major pharmaceutical companies are placing significant emphasis on reducing spiralling R&D expenditures and improving productivity. Clinical trials cost estimates positively affect the quality of stop/go decision making in late stage clinical development. The major quantitative challenge has been identified as how to estimate a priori the cost of clinical trials and prior research on this subject has been based upon a limited sample of drugs in development and depends upon average cost data released by the industry. The application of parametric cost analysis to pharmaceutical development can help reduce the uncertainty and the degree of approximation of the cost estimates.

Keywords: pharmaceutical R&D; cost estimates; clinical trials; parametric cost analysis; PCA; research and development; uncertainty; drug development.

DOI: 10.1504/IJTIP.2007.015771

International Journal of Technology Intelligence and Planning, 2007 Vol.3 No.3, pp.233 - 245

Published online: 14 Nov 2007 *

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