Review by Joseph Ross – 04/07/2019 – 9:57pm

Data Request Number: 2019-3840 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, would defer to Data Holder Due Diligence Assessment Please use this space to provide any comments, feedback or concerns (optional):

This is an interesting proposal to use data from 3 trials to predict new atrial fibrillation among patients receiving ibrutinib. I have 1 concern and 1 request for clarification. My concern is that the data the investigators have requested are not prepared as part of a de-identified patient data set, specifically the patients’ baseline ECG and echocardiographic measures. The data generator should confirm whether these data elements are available.
My request for clarification relates to the validation part of the proposal. It seems the data from 3 trials are being used to develop a predictive algorithm to that identifies patients at higher risk for new atrial fibrillation when receiving ibrutinib. The investigators then explain that they will test this algorithm on a historical control data source. What data source is this? It’s never described. A few details would be useful. Also, please clarify if both ECG and echocardiographic measures will be used as part of algorithm development (in addition to clinical and laboratory parameters), as most of the text seems focused only on the ECG measures.

Recommendation for this data request: Not Approve

See comments above.