Clinical research informatics

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Clinical research informatics (CRI) is a subdomain of biomedical and health informatics that focuses on the application of informatics to the discovery and management of new knowledge relating to health and disease. It includes management of information related to clinical trials, and also involves informatics related to secondary research use of clinical data. Clinical research informatics and Translational Bioinformatics are the primary domains related to informatics activities that support translational research[1].

Background

The definition of CRI is in flux as it emerges as a subdiscipline. A 2009 definition focused CRI specifically on the domain of clinical research (human clinical trials and studies) but acknowledged that CRI also touches on the domain of translational research[2] (in medicine, translational research activities are those which precede and follow human clinical research activities; sometimes referred to as "bench to bedside" and and "bedside to community," respectively]).

A 2012 definition, however, took a wider view, suggesting that CRI "...focuses on developing new informatics theories, tools, and solutions to accelerate the full translational continuum: basic research to clinical trials, clinical trials to academic health center practice, diffusion and implementation to community practice, and 'real world' outcomes"[3]. If this broader definition becomes widely adopted, CRI could merge with another emerging informatics subdomain, translational research informatics (TRI).

CRI related standards

CDISC develops several standards. Some of them are adopted by FDA for regulatory submissions. Operational Data Mode (ODM) is the most generic CRI CDISC standard.

CRI historical development

CRI is rapidly evolving and growing, in part due to increasingly complex clinical research workflow and information management challenges[2]. Underlying reasons for this evolution and growth include:

  • The rapid pace of biomedical science and the need for advances in medicine, which create pressure for clinical research to be conducted in a timely and efficient manner and also produce high-quality results[2]
  • The associated need to make clinical care data available for secondary use in support of clinical research[2]
  • The use of sophisticated biomedical research techniques that generate massive and ever-growing data sets (aka Big Data)[4]
  • The need for computer programs and other tools that can evaluate, combine, and visualize these large quantities of data not only on supercomputers, but also on PCs and workstations[4]
  • Challenges presented by the regulatory requirements associated with conducting clinical studies, including a trend toward conducting clinical trials in community practice settings instead of large academic health centers (AHCs)[2]

In addition to these factors, CRI development has been accelerated by an increase in the scope and pace of clinical and translational science advancements funded by programs such as the National Institutes of Health's (NIH) Roadmap for Medical Research initiative[2]. Roadmap programs related to CRI include:

Additional efforts

Other major initiatives, programs, and activities related to CRI include:

Related Articles

Related concepts

References

  1. American Medical Informatics Association (AMIA). Informatics areas: clinical research informatics [Online]. 2012 [cited 2012 Nov 25]; Available from: URL:http://www.amia.org/applications-informatics/clinical-research-informatics
  2. Embi PJ, Payne PR. Clinical research informatics: challenges, opportunities and definition for an emerging domain. J Am Med Inform Assoc 2009;16:323, 325.
  3. Kahn MG, Weng C. Clinical research informatics: a conceptual perspective. J Am Med Inform Assoc 2012 Apr [cited 2012 Nov 25]; 19(e1):[e36-42]. Available from: URL:http://jamia.bmj.com.liboff.ohsu.edu/content/19/e1/e36.full.pdf+html
  4. National Institutes of Health (NIH). Common fund makes new FY2010 wwards for National Centers for Biomedical Computing [Online]. [cited 2012 Nov 25]; Available from: URL:https://commonfund.nih.gov/bioinformatics/overview.aspx
  5. NIH National Center for Advancing Translational Sciences (NCATS). Clinical and Translational Science Awards [Online]. [cited 2012 Nov 25]; Available from: URL:http://www.ncats.nih.gov/research/cts/ctsa/ctsa.html

External resources

Submitted by Deb Woodcock