Abstract
The cost of drug development has risen markedly in the past 30 years, with studies now reporting values exceeding US $800 million. As these spiralling costs threaten to make the development of new drugs increasingly unaffordable for both developing companies and consumers, it is clear that efforts should be made to address this problem. All aspects of the drug discovery and development process should be examined for potential cost savings, but I focus here in particular on the current regulatory requirements.
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References
Boston Consulting Group. A Revolution in R&D: How Genomics and Genetics are Transforming the Biopharmaceutical Industry. (Boston Consulting Group, Boston, Massachusetts, 2001).
DiMasi, J., Hansen, R. W. & Grabowski, H. G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003).
Relman, A. S. & Angell, M. America's other drug problem. The New Republic 16, 27–41 (2002).
Public Citizen. America's Other Drug Problem: a Briefing Book on the Rx Drug Debate (Public Citizen, Washington DC, 2002).
Grabowski, H. G. & Vernon, J. M. Returns to R&D on new introductions in the 1980s. J. Health Econ. 13, 383–406 (1994).
Nuffield Council on Bioethics. Pharmacogenetics: Ethical Issues. (Nuffield Council on Bioethics, London, 2003).
Sherman, B. & Ross, P. The failure of industrialised research. Acumen J. Life Sci. 1, 121–127 (2003).
Harris, G. Where are all the new drugs? The New York Times (5 Oct 2003).
Versteegh, L. R. Science and regulatory rituals associated with the drug development process. Food Drug Law J. 52, 155–161 (1997).
Jefferys, D. B., Leakey, D., Lewis, J. A., Payne, S. & Rawlins, M. D. New active substances authorized in the United Kingdom between 1972 and 1994. Br. J. Clin. Pharmacol. 45, 151–156 (1998).
Altman, D. G. & Bland, J. M. Statistical notes. Treatment allocation in controlled trials: why randomise? BMJ 318, 1209 (1999).
Pocock, S. J. & Elbourne, D. R. Randomized trials or observational tribulations? N. Engl. J. Med. 342, 1907–1909 (2000).
Niblack, J. F. Why are drug development programs growing in size and cost? A view from industry. Food Drug Law J. 52, 151–154 (1997).
Peck, C. C., Rubin, D. B. & Sheiner, L. B. Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin. Pharmacol. Ther. 73, 481–490 (2003).
Institute of Medicine. Small Clinical Trials: Issues and Challenges (Institute of Medicine, Washington DC, 2001)
Concato, J., Shah, N. & Horwitz, R. I. Randomised controlled trials, observational studies, and the hierarchy of research designs. N. Engl. J. Med. 342, 1887–1892 (2000).
Barr, D. P. et al. Design considerations for AIDS trials. N. Engl. J. Med. 323, 1343–1348 (1990).
Senn, S. Statistical Issues in Drug Development (Wiley, Chichester, 1997).
Lilford, R. J. & Brauanholtz, D. The statistical basis of public policy: a paradigm shift is overdue. BMJ 313, 603–607 (1996).
Speigelhalter, D. J., Myles, J. P., Jones, D. R. & Abrams, K. R. Bayesian methods in health technology assessment: a review. Health Technol. Assess. 4 (38), (2000).
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Rawlins, M. Cutting the cost of drug development?. Nat Rev Drug Discov 3, 360–364 (2004). https://doi.org/10.1038/nrd1347
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DOI: https://doi.org/10.1038/nrd1347
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