elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials (original) (raw)
A Correction to this article was published on 22 July 2021
This article has been updated
Abstract
In clinical studies there are huge numbers of laboratory parameters available that are measured at several visits for several treatment groups. The status quo for presenting laboratory data in clinical trials consists in generating large numbers of tables and data listings. Such tables and listings are required for submissions to health authorities. However, reviewing laboratory data presented in the form of tables and listings is a lengthy and tedious process. Thus, to enable efficient exploration of laboratory data we developed elaborator, a comprehensive and easy-to-use interactive browser-based application. The elaborator app comprises three analyses types for addressing different questions, for example about changes in laboratory values that frequently occur, treatment-related changes and changes beyond the normal ranges. In this way, the app can be used by study teams for identifying safety signals in a clinical trial as well as for generating hypotheses that are further inspected with detailed analyses and possibly data from other sources. The elaborator app is implemented in the statistical software R. The R package elaborator can be obtained from https://cran.r-project.org/package=elaborator. Patients’ laboratory data need to be extracted from the clinical database and pre-processed locally for feeding into the app. For exploring data by means of the elaborator, the user needs some familiarity with R but no programming knowledge is required.
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Change history
22 July 2021
A Correction to this paper has been published: https://doi.org/10.1007/s43441-021-00326-4
Notes
- As there are three possibilities for a change (i.e., increase, decrease and stability) between two adjacent visits, and 4–1 transitions from one visit to the next in the considered example, there are 27 possible time courses.
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Acknowledgements
The authors thank Nicole Mentenich for proof-reading the manuscript.
Funding
The development of elaborator and the preparation of this manuscript were sponsored by Bayer AG.
Author information
Authors and Affiliations
- Research & Development, Pharmaceuticals, Statistics and Data Insights, Bayer AG, 13342, Berlin, Germany
Silke Janitza PhD & Hermann Kulmann PhD - Bayer US LLC, Whippany, NJ, USA
Madhurima Majumder PhD - Bayer AG, Wuppertal, Germany
Franco Mendolia PhD - Chrestos Concept GmbH & Co. KG, Essen, Germany
Steffen Jeske MSc
Authors
- Silke Janitza PhD
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Contributions
All authors constituted the project team that developed the app. SJ is the main contributor of the manuscript. StJ supported the team in the implementation of the app.
Corresponding author
Correspondence toSilke Janitza PhD.
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Conflict of interest
Silke Janitza, Madhurima Majumder,· Franco Mendolia, Steffen Jeske, Hermann Kulmann have no conflicts of interest.
Additional information
The original online version of this article was revised because, due to a Production error, it was published without author corrections.
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Janitza, S., Majumder, M., Mendolia, F. et al. elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials.Ther Innov Regul Sci 55, 1220–1229 (2021). https://doi.org/10.1007/s43441-021-00318-4
- Received: 08 February 2021
- Accepted: 18 June 2021
- Published: 01 July 2021
- Issue Date: November 2021
- DOI: https://doi.org/10.1007/s43441-021-00318-4