Approaches for Clinical Supply Modelling and Simulation

Patel, Nitin R.; Ankolekar, Suresh; Senchaudhuri, Pralay

doi:10.1007/978-1-4939-1100-4_15

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Lessons Learned Best Practices and Recommendations For Add1

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“…Modeling approaches for projecting clinical supply needs 27 and patient recruitment 28,29 could be utilized to model and simulate changes to enrollment and the associated drug supply implications when adaptive trials are being planned, and while ongoing.…”

Section: Lessons Learned Best Practices and Recommendations For Addmentioning

confidence: 99%

Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs

Gallo

Miller

et al. 2017

Ther Innov Regul Sci

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The draft adaptive design guidance released by FDA in 2010 included references to adaptive study designs that were described as "less well-understood." At that time, there was relatively little regulatory experience with such designs, and their properties were felt to be insufficiently understood. In order to promote greater use of adaptive designs, especially those categorized as less well-understood, the Best Practice Subteam of the DIA Adaptive Designs Scientific Working Group (ADSWG) has worked on describing and characterizing these designs, identifying challenges associated with them and suggesting improvements to design or study conduct aspects that might make them more acceptable. This paper summarizes the work from the subteam.

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Section: Lessons Learned Best Practices and Recommendations For Addmentioning

confidence: 99%