Abstract
Background
The interest in adaptive study design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development. Little has been published on the practical application and merits of adaptive study design in early phase clinical research.
Methods
This paper describes a retrospective analysis performed on a sample of 29 industry lead adaptive early phase studies commencing between 1 January 2006 and 31 December 2010 in a clinical trials unit in London, England. All studies containing at least one adaptive feature in the original protocol were included in the analysis. The scope of the analysis was to assess whether the use of adaptive study designs provided tangible benefits over the use of conventional study designs using time savings as the main measure.
Conclusion
We conclude that the use of adaptive study design saves time in early phase research programs. This is achieved by abolishing the need for substantial amendments or by mitigating their impact on timelines and by using adaptive scheduling efficiencies.
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Declaration of interest
The authors are employed by Richmond Pharmacology Ltd, a specialist contract research organisation conducting early phase clinical research, based in London, England.
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Lorch, U., Berelowitz, K., Ozen, C. et al. The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Eur J Clin Pharmacol 68, 543–551 (2012). https://doi.org/10.1007/s00228-011-1176-3
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DOI: https://doi.org/10.1007/s00228-011-1176-3