Open Data Revolution in Clinical Research: Opportunities and Challenges

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.

The importance of adherence to international standards for depositing open data in public repositories

“…In addition, in certain contexts, it is advisable the use of controlled-access repositories, in which the researchers need to apply to get access to the data. In specific cases of highly sensitive information, there is the option for the submission of processed data, such as summary statistics [ 25 , 28 ]. The International Committee of Medical Journal Editors (ICMJE) requires, since 2017, that articles reporting the results of clinical trials should include a data sharing statement [ 30 ].…”

“…The International Committee of Medical Journal Editors (ICMJE) requires, since 2017, that articles reporting the results of clinical trials should include a data sharing statement [ 30 ]. There are two major interesting examples of international sharing of data from patients and the development of important scientific findings and collaborations [ 28 ]: the Alzheimer’s Disease Neuroimaging Initiative (ADNI; adni.loni.usc.edu) has led to more than 2.100 international publications [ 31 ] and The Cancer Imaging Archive (TCIA; cancerimagingarchive.net) has facilitated the generation of more than 1.100 international publications [ 32 ]. In some regions of the world, there is the need for further training for members of research ethics committees about the multiple advantages of sharing data for the advancement of health sciences research [ 27 , 28 ].…”

“…There are several ethical aspects related to the sharing of data from human subjects, such as de-identification and having appropriate informed consents and approval by the institutional review boards [26][27][28][29]. In addition, in certain contexts, it is advisable the use of controlledaccess repositories, in which the researchers need to apply to get access to the data.…”

“…net) has facilitated the generation of more than 1.100 international publications [32]. In some regions of the world, there is the need for further training for members of research ethics committees about the multiple advantages of sharing data for the advancement of health sciences research [27,28].…”

Influence of Subject-Specific Effects in Longitudinal Modelling of Cognitive Decline in Alzheimer’s Disease

“…Identifying the demographic characteristics these cognitive assessments most strongly associate with is central to ADRD research as they help inform how these characteristics relate to longitudinal changes in cognition and, in turn, decline in clinical function [ 15–17 ]. This has led to development of statistical models of decline which not only identify factors influencing these outcomes, such as genetic carrier status of the Apolipoprotein E4 ( APOE4 ) allele and its relation to cognitive and functional capacity [ 18, 19 ], but can also be used for outcome prediction [ 20 ].…”