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 ApproveSee 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.