Team building: electronic management-clinical translational research (eM-CTR) systems.
Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.
Cecchetti
Alfred A
AA
University of Pittsburgh, Center for Clinical Pharmacology, Pittsburgh, Pennsylvania, USA.
Parmanto
Bambang
B
Vecchio
Marcella L
ML
Ahmad
Sjarif
S
Buch
Shama
S
Zgheib
Nathalie K
NK
Groark
Stephen J
SJ
Vemuganti
Anupama
A
Romkes
Marjorie
M
Sciurba
Frank
F
Donahoe
Michael P
MP
Branch
Robert A
RA
D006285:Health Planning; D006801:Humans; D033183:Interdisciplinary Communication; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy; D013685:Telecommunications; D057170:Translational Research, Biomedical