An Open-Access Dataset of Thorough QT Studies Results

Round 1

Reviewer 1 Report

Wiśniowska and coauthors provided the first open-access dataset of thorough QT studies. This is a very important and useful database that could help the community to assess the predictive performance of biomarkers for QT prolongation effect using modeling approaches. I found the summary succinct and clear, the data descriptor essential and easy to read and the method section well organized and comprehensive. In conclusion, I found the current report with its freely available set of data very useful for the community.

 

Author Response

Thank you for your time and the review of the manuscript.

Reviewer 2 Report

Wisniowska and coauthors presented an open-access dataset in which they collected information about electrocardiogram QT and corrected QT modification induced by several drugs in their early phase evaluation studies. Data were retrieved from common clinical and chemical online databases using generic search terms between Nov 2018 and Jan 2019. Each study was analyzed for the population and for the pharmacodynamic and pharmacokinetic characteristics of the drug. The merit of this work is to bring together sparse information about thorough QT studies for future pharmacological and clinical development. I don’t have major concerns about this paper, just some requests for the authors.

Specify the time range of the included studies. Explicit the abbreviation before reporting it: TQT, ICH, TdP, hERG, CiPA, ADME, etc. In row 37, before reference [4] the phrase seems incomplete.   

 

Author Response

Thank you for your time and the review of the manuscript.

Time range - It is hard to specify the time range of studies themself as in most cases the authors do don't report when the study was run. However, a sentence on time range of results publication was added.

Abbreviations - many of the abbreviations appear first in the abstract, as there is word limit for the abstract we decide to not explain them there. They are explain in the further paragraphs.

The incomplete sentence has been corrected.