Kit Supply Algorithms to Protect the Integrity of Blinded Randomized Clinical Trials
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*Ron Yu, Genentech 


In order to protect the integrity of a randomized blinded trial, the kit supply strategy is one important aspect of the trial conduct to be carefully evaluated. Clinical trials bear unnecessary risk of providing unblinding information to the investigators when kit supply strategy is poorly designed. We show that partial unblinding (e.g. investigator learns that two patients are on the same treatment arm even though he or she does not know the type of treatment both patients are receiving) has a sizable chance of occurring with the current standard IVRS kit supply strategy. There is always a trade-off between selection bias and kit wastage. We will point out a few pitfalls with common approaches used in practice, introduce alternative supply strategies and comment on their properties. Presentation 2 Title: Dynamic Allocation: A Case Study