Review by Richard Lehman – 04/09/2020 – 7:08pm

Data Request Number: 2020-4244 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?: No If no, please explain:

The fact that the requestor has not answered our concerns in any substantive way suggests that they do not have the skills required to carry out a complex network m/a of the kind they propose. Their statistical plan is still very poorly described in a way that suggests lack of expertise or methodological experience within the team.

Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Recommendation for this data request: Not Approve

See above. I was initially willing to give the requestor the benefit of the doubt since these trials would only form a small part of their project, but on reviewing their response I do not think they have made a convincing case that justifies the effort of processing the IPD for their benefit.