Driving Clinical and Translational Research Using Biomedical Informatics - Translational Informatics: Realizing the Promise of Knowledge-Driven Healthcare - page 96

As described in a number of recently published reports, the conduct of CTR is chal-
lenging due to a variety of technical and socio-cultural factors. In one seminal report
sponsored by the Institute of Medicine (IOM) and authored by Sung and colleagues, a
set of critical “barriers” that exist in the CTR cycle were enumerated, namely [ 1 - 5 ]:

￿ A “ T1 ” barrier between the knowledge generated in laboratory studies and the
design/conduct of clinical studies informed by that knowledge;
￿ A “ T2 ” barrier between the knowledge generated in clinical studies and the dis-
semination/adoption of that knowledge in clinical care setting; and
￿ Multiple barriers, including those labeled as “ T3 ” and beyond , that serve to
impede the translation of knowledge across and between settings and communities
after such evidence has been generated and initially disseminated via traditional
research processes.

Underlying these barriers are numerous informatics-relevant challenges, such as
those associated with: (1) providing effi cient and high quality data collection instru-
ments; (2) facilitating the integration and “normalization” of complex and heteroge-
neous data sets; (3) analyzing multi-dimensional data and information in a manner that
leverages the best available quantitative practices and pre-existing knowledge bases;
and (4) representing and disseminating knowledge in a manner that ensures that those
products are both transportable and understandable (by humans and computers alike).
These challenges are, in large part, the result of a combination of technical, cultural,
and organizational impediments, with examples of such issues enumerated in Table 6.1 .

6.2 A Primer on Clinical and Translational Research

In the following discussion, we briefl y review the basic defi nitions, constructs, and
frameworks that underlie most, if not all, CTR projects. Specifi cally, we will fi rst
describe the basic components that make up a traditional clinical trial or study, and
then describe how such models can be extended or enhanced to yield more transla-
tional investigative paradigms.

6.2.1 Clinical Studies

The National Institute for General Medical Sciences (NIGMS) defi nes a clinical
trial as a “ scientifi c study in which physician - researchers study the effects of poten-
tial medicines on people ; usually conducted in three phases ( I , II , and III ) that
determine safety , whether the treatment works , and if it ' s better than current thera-
pies , respectively ” [ 6 ]. Of note, a potential limitation to this defi nition is that it only
references medical treatment modalities. In reality, clinical trials can incorporate
additional therapeutic and non-therapeutic approaches, including surgery, medical
devices, and tissue banking. In addition, there are various types of clinical studies