Review by Joseph Ross – 01/28/2020 – 5:36pm

Data Request Number: 2019-3990 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):

The requestor is not looking to do any analysis with the IPD. Instead, they are looking for specific information, that might be in the CSR but may not be: “I kindly wonder if I could get following results from the COU-AA-302 trial’s mixed models for repeated measures (MMRM) analyses:
The mean change with 95% CI in FACT-P total score, from baseline to cycle 3 (84 days), in the abiraterone-prednisone treatment arm.
The mean change with 95% CI in FACT-P total score, from baseline to cycle 3 (84 days), in the prednisone-alone treatment arm. ”
It would be helpful if the requestor could clarify whether they would do the analysis if this information is not in the CSR, or is only asking for someone else to provide this information to them.

 Recommendation for this data request: Not Approve

see above