Review by Joseph Ross – 05/31/2016 – 2:23pm

Data Request Number: 2016-0903 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):

The authors explain that they have identified 17 RCTs described in full text articles that are eligible for inclusion. Since only 4 are available through the YODA project, are the other 13 being requested in parallel? Are these trials also available through data sharing platforms or are they being requested directly from biologic manufacturers? It would be useful if the proposal listed the 17 identified published trials, or at least clearly cited them.
Also, the proposal suggests that each of the 17 trials for which data are able to be obtained will be analyzed as pre-specified (ie, stratified by concomitant use of high-dose steroids, low-dose steroids, or no steroids), and then those estimates will be used for a pooled meta-analysis. Please confirm that the plan is not to pool IPD from 17 trials within the data sharing platform for analysis.

Recommendation for this data request: Approve