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Year : 2010  |  Volume : 42  |  Issue : 4  |  Page : 201--207

Adaptive design clinical trials: Methodology, challenges and prospect

Rajiv Mahajan1, Kapil Gupta2 
1 Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, Punjab, India
2 Department of Biochemistry, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, Punjab, India

Correspondence Address:
Rajiv Mahajan
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, Punjab
India

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.


How to cite this article:
Mahajan R, Gupta K. Adaptive design clinical trials: Methodology, challenges and prospect.Indian J Pharmacol 2010;42:201-207


How to cite this URL:
Mahajan R, Gupta K. Adaptive design clinical trials: Methodology, challenges and prospect. Indian J Pharmacol [serial online] 2010 [cited 2022 Aug 17 ];42:201-207
Available from: https://www.ijp-online.com/article.asp?issn=0253-7613;year=2010;volume=42;issue=4;spage=201;epage=207;aulast=Mahajan;type=0