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Review
. 2020 Jul;13(4):665-674.
doi: 10.1111/cts.12756. Epub 2020 Mar 10.

Open Data Revolution in Clinical Research: Opportunities and Challenges

Mohamed H Shahin  1 , Sanchita Bhattacharya  2   3 , Diego Silva  4   5 , Sarah Kim  6 , Jackson Burton  7 , Jagdeep Podichetty  7 , Klaus Romero  7 , Daniela J Conrado  8
Affiliations
Review

Open Data Revolution in Clinical Research: Opportunities and Challenges

Mohamed H Shahin et al. Clin Transl Sci. 2020 Jul.

Abstract

Efforts for sharing individual clinical data are gaining momentum due to a heightened recognition that integrated data sets can catalyze biomedical discoveries and drug development. Among the benefits are the fact that data sharing can help generate and investigate new research hypothesis beyond those explored in the original study. Despite several accomplishments establishing public systems and guidance for data sharing in clinical trials, this practice is not the norm. Among the reasons are ethical challenges, such as privacy of individuals, data ownership, and control. This paper creates awareness of the potential benefits and challenges of sharing individual clinical data, how to overcome these challenges, and how as a clinical pharmacology community we can shape future directions in this field.

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Conflict of interest statement

M.H.S. is an employee of Pfizer Inc. J.B. is an employee of the Critical Path Institute. J.P. is an employee of the Critical Path Institute. K.R. is an employee of the Critical Path Institute. D.J.C. was an employee of the Critical Path Institute. All other authors declared no competing interests for this work.

Figures

Figure 1
Figure 1
Benefits of clinical trial data sharing.
Figure 2
Figure 2
Accomplishments of establishing public systems and guidance for data sharing in clinical trials. FDAAA, Food and Drug Administration Amendments Act; FDAMA, Food and Drug Administration Modernization Act; ICMJE, International Committee of Medical Journal Editors.
Figure 3
Figure 3
Stages for the creation of an integrated clinical database under an expanded data‐sharing approach (modified from22). NIH, National Institutes of Health.
See this image and copyright information in PMC

References

    1. The data deluge. Nat. Cell Biol. 14, 775 (2012). - PubMed
    1. Qian, T. , Zhu, S. & Hoshida, Y. Use of big data in drug development for precision medicine: an update. Expert Rev. Precis. Med. Drug Dev. 4, 189–200 (2019). - PMC - PubMed
    1. Drazen, J.M. Sharing individual patient data from clinical trials. N. Engl. J. Med. 372, 201–202 (2015). - PubMed
    1. Mello, M.M. et al Preparing for responsible sharing of clinical trial data. N. Engl. J. Med. 369, 1651–1658 (2013). - PubMed
    1. Koenig, F. et al Sharing clinical trial data on patient level: opportunities and challenges. Biom. J. Biom. Z. 57, 8–26 (2015). - PMC - PubMed

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