Review by Cary Gross – 12/22/2016 – 9:13pm

Data Request Number: 2016-1171 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Unsure, further clarification from requestor is needed Please use this space to provide any comments, feedback or concerns (optional):

This is an interesting and important question.
It is unclear whether the trial data set will include the subsequent therapies patients received – particularly if they received them more than a year after the initial randomization.  Should confirm the reliability of these data by asking the study sponsor.
When comparing different types of subsequent therapy (i.e. the investigators list 7 different categories), it is unclear how immortal time bias will be addressed.  That is, some patients would have to live long enough to receive the second line therapy.  Some investigators impose  minimal survival time in order to address this.

Recommendation for this data request: Not Approve

Need to confirm availability of these subsequent treatment data