TL46: Issues in Clinical Trials with a Time Lag between Randomization and Initiation of Treatment
*Chunrong Cheng, FDA/CBER 


In some clinical trials, there is a time lag between randomization and the initiation of treatment due to the individualized production of investigated product. When the time lag is long enough, a substantial proportion of subjects may drop out during this period and result in missing data. Due to production failure, subjects randomized to the treatment group may also be forced to drop out. Bias will be introduced if excluding these subjects from the analyses. This session will discuss statistical strategies to deal with this issue and the feasibility of alternative timing for randomization.