SummerSim 2017: The Reference Model Models ClinicalTrials.Gov - Reviewer Dan Zelterman

[Jacob Barhak]

This is not exactly what I do but I can make a few useful comments on the manuscript. I am OK with it being unblinded. I am not hiding anything and have become bolder in the process!

Anyway. Here goes.

Overall: This is a good idea. The clinicaltrials.gov database is a rich source of useful information. It is nice to see it is being used for these purposes. My own interactions with this database is for a very narrow focused search.

On the downside: The proposed uses do not include a qualitative aspect. Specifically, some trials are worth so much more than others. Some trials are terminated early because of unexpected patient side effects or if a better treatment comes along. Yet other trials become landmark findings and influence medical decisions for years afterwards. As a result, any good meta-analysis will have a (possibly subjective) measure of quality or influence, sometimes in a Bayesian framework. The search does not include this additional useful information.

In general: Write using the active voice! Write in the first person! The Abstract contains this passive, third-person gem: "Collecting these data elements from the literature was extremely tedious." Tedious for whom? Instead, write: "We found collecting these data elements to be tedious." But then again: Who cares? You did the research so everybody assumes there was lots of tedious work involved. Get over it!

I would strongly suggest a thorough re-write of the whole document with the help of a patient editor. I have found this action to be helpful.

Dan Zelterman

[Jacob Barhak]

The second review round the reviewer provided a pdf with comments on the scanned paper. The pdf file is attached..

[Jacob Barhak]

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Final response from Dan Zelterman:

Robert –

This is fine. Thanks for sharing it with me.

Best, Dan