Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.
From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).
Adaptive Trial Design: Streamlining the Clinical Supply Process is presented by Geert Langendries, Covance IVRS Project Management Group. This audio conference was recorded on 2007-12-05 and is now available for download at www.fxconferences.com
