Clinical Research Informatics for Big Data and Precision Medicine.
OBJECTIVE
To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI.


METHODS
We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research.


RESULTS
The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges.


CONCLUSIONS
The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.
Chunhua Weng, PhD, FACMI, Department of Biomedical Informatics, Columbia University, 622 W 168 Street, PH-20, New York, NY 10032, USA, E-mail: chunhua@columbia.edu.
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D035843:Biomedical Research / Q000639:trends; D057225:Data Mining; D066264:Datasets as Topic; D057286:Electronic Health Records; D006801:Humans; D020407:Internet; D008490:Medical Informatics / Q000639:trends; D057285:Precision Medicine
Evidence-based medicine; data bank; data quality; electronic health records; individualized medicine; learning health system; patient selection