Review by Nihar Desai – 08/16/2016 – 2:58pm

Data Request Number: 2016-1005 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):

Can the authors provide additional details about the sample size.  They report that 20-30% of subjects do not achieve a therapeutic response and propose to develop a predictive model to identify features associated with lack of efficacy.  How many subjects will they have between all of the studies requested?  Do they have adequate statistical power to test all of the variables they propose to include?  How can they determine whether the lack of efficacy is due to non-adherence to study medications?

 Recommendation for this data request: Not Approve

Can the authors provide additional details about the sample size. They report that 20-30% of subjects do not achieve a therapeutic response and propose to develop a predictive model to identify features associated with lack of efficacy. How many subjects will they have between all of the studies requested? Do they have adequate statistical power to test all of the variables they propose to include? How can they determine whether the lack of efficacy is due to non-adherence to study medications?