Review by Richard Lehman – 10/21/2020 – 7:42am

Data Request Number: 2020-4444 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?: Unsure, further clarification from requestor is needed 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):

The hypothesis that expectancy effects are important in ADHD drug treatment is certainly worth testing. However I am not convinced that the proposed surrogate has any validity: “The RCT must have a measure of group assignment belief encoded into the data. This may be a blindedness measure, where participants guessed their group assignment. I will use this coarse measure of expectancy to perform a two by two analysis based on both actual group assignment and group assignment belief.” 
I am also not sure that such information is available in the CSRs.
So it is hard to know on what data this analysis can be grounded.

 Recommendation for this data request: Not Approve

See comments above.

It seems to me unlikely that there will be enough information on participants’ guesses about their treatment allocation to ground this analysis, which in any case would be inadequate to validate the proposed hypothesis.