Review by Joseph Ross – 05/11/2018 – 4:59pm

Data Request Number: 2018-2946 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?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

This is an interesting exploratory study examining the incidence of (and reasons behind) re-challenging patients with trabectedin after experiencing drug related CK elevation. My only concern with the proposal is with whether the investigators know what the 4 RCT protocols required investigators to do in the event of a CK elevation during the trial. Did the investigators have any leeway to decide whether or not to re-challenge patient with trabectedin? Or were investigators told to discontinue treatment for the remainder of the trial?
This study will only be able to characterize incidence in the trials, not in the real world, and the trials may have had explicit protocols instructing investigators what to do in the event of a CK elevation.

Recommendation for this data request: Approve