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Indian Journal of Pharmacology
Medknow Publications on behalf of Indian Pharmacological Society
ISSN: 0253-7613 EISSN: 0253-7613
Vol. 42, No. 4, 2010, pp. 201-207
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Bioline Code: ph10060
Full paper language: English
Document type: Symposium
Document available free of charge
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Indian Journal of Pharmacology, Vol. 42, No. 4, 2010, pp. 201-207
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Adaptive design clinical trials: Methodology, challenges and prospect
Mahajan, Rajiv & Gupta, Kapil
Abstract
New drug development is a time-consuming and expensive process. Recently, there has been stagnation in the development of novel compounds. Moreover, the attrition rate in clinical research is also on the rise. Fearing more stagnation, the Food and Drug Administration released the critical path initiative in 2004 and critical path opportunity list in 2006 thus highlighting the need of advancing innovative trial designs. One of the innovations suggested was the adaptive designed clinical trials, a method promoting introduction of pre-specified modifications in the design or statistical procedures of an on-going trial depending on the data generated from the concerned trial thus making a trial more flexible. The adaptive design trials are proposed to boost clinical research by cutting on the cost and time factor. Although the concept of adaptive designed clinical trials is round-the-corner for the last 40 years, there is still lack of uniformity and understanding on this issue. This review highlights important adaptive designed methodologies besides covering the regulatory positions on this issue.
Keywords
Adaptation, clinical trials, innovations, statistical analysis
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© Copyright 2010 Indian Journal of Pharmacology. Alternative site location: http://www.ijp-online.com
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