Summary
Objectives: 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.
Conclusion: 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.
Keywords
Evidence-based medicine - learning health system - individualized medicine - patient
selection - electronic health records - data bank; data quality