Clinical Research Informatics [CRI]
Clinical research is about finding the best way for patients to receive medical care. The NIH
defines clinical research in three parts: a) patient-oriented (research involving interaction with
human subjects), b) epidemiologic and behavioural, and c) outcomes and health services
research.
Clinical research is a branch of medical science that determines the safety and effectiveness
of medications, devices, diagnostic products and treatment regimens intended for human use.
These may be used for prevention, treatment, diagnosis or for relieving symptoms of a
disease. Clinical Research is different than clinical practice. In clinical practice one uses
established treatments, while in clinical research evidence is collected to establish a
treatment.
The term clinical research refers to the entire bibliography of a drug/device/biologic, in fact
any test article from its inception in the lab to its introduction to the consumer market and
beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected
to pre-clinical studies or animal studies where different aspects of the test article (including
its safety toxicity if applicable and efficacy, if possible at this early stage) are studied.
Clinical Trials
Clinical research is often conducted at academic medical centers and affiliated research study
sites. These centers and sites provide the prestige of the academic institution as well as access
to larger metropolitan areas, providing a larger pool of medical participants.
Clinical research includes clinical trials, which are studies that evaluate the effectiveness and
safety of medical devices or drugs. These studies are conducted according to a formal
protocol, which defines what kind of patient can participate, when and how much treatment is
given, what is being measured, and the overall duration of the study.
The clinical research ecosystem involves a complex network of sites, pharmaceutical
companies and academic research institutions. This has led to a growing field of technologies
used for managing the data and operational factors of clinical research. Clinical research
management is often aided by eClinical systems to help automate the management and
conducting of clinical trials.
In the European Union, the European Medicines Agency (EMA) acts in a similar fashion for
studies conducted in their region. These human studies are conducted in four phases in
research subjects that give consent to participate in the clinical trials.
Clinical Research Informatics
 Clinical Research Informatics (CRI) is the subdomain of biomedical informatics
concerned with the development, application, and evaluation of theories, methods,
and systems to optimize the design and conduct of clinical research and the
analysis, interpretation, and dissemination of the information generated.
 Clinical Research Informatics involves the use of informatics in 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
to support translational research.
 Clinical research informatics (CRI) is the application of informatics principles and
techniques to support the spectrum of activities and business processes that
instantiate clinical research. Informatics, defined generally as the intersection of
information and computer science with a health-related discipline, has a foundation
drawn from many well-established, theory-based disciplines, including computer
science, library and information science, cognitive science, psychology, and
sociology.
The newly articulated yet fundamental theorem of informatics states that information
technology should be used to enable humans to function and perform better together than
humans alone, and so informatics is a source for supportive technologies and tools that
enhance – but not replace – unreservedly human processes.
Clinical Research Informatics contributes to the ongoing dialogues among researchers and
practitioners in CRI as they continue to rise to the challenges of a dynamic and evolving
clinical research environment. The development of CRI as a sub-discipline of informatics,
and as an independent/maturing professional practice area in its own right, drives a growing
pool of scientific literature based on original CRI research, and high-impact tools and systems
will be developed. CRI leaders and stakeholder groups will continue to support and create
communities of discourse that will address much needed practice standards in CRI, improved
safety and efficiencies in clinical research, data standards in clinical research, policy issues,
educational standards and instructional resources.