Review by Richard Lehman – 07/12/2017 – 2:33pm

Data Request Number: 2017-1746 Is the scientific purpose of the research proposal clearly described?: No If no, please explain:

“Co-morbidity” is a very general term and it needs to be specified much more clearly in relation to the participants of these condition-specific trials. The example given (CVD /COPD) does not apply to any of them.

Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: No If no, please explain:

The trials requested mostly give data for conditions seen in younger patients, who may have various types of co-morbidity related to the disease in question but are unlikely to have high rates of other comorbidities. As previously stated, I don’t think the research question has been framed with sufficient clarity. What is the pre-specified hypothesis? Is this just a data trawl for associations? Which co-morbidities are being looked for? Why?

Can the proposed research be reasonably addressed using the requested data?: No If no, please explain:

I do not think the research question is clear.

Recommendation for this data request: Not Approve

The research question is unclear and does not prespecify the associations being looked for.