The Cardiac Safety Research Consortium enters its second decade: An invitation to participate.
The Cardiac Safety Research Consortium (CSRC), a transparent, public-private partnership established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University, is entering its second decade. Our continuing goal is to advance paradigms for more efficient regulatory science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where such safety questions add burden to innovative research and development. Operationally, CSRC brings together a broad base of stakeholders from academia, industry, and government agencies in a collaborative forum focused on identifying barriers and then creating novel solutions through shared data, expertise, and collaborative research. This white paper provides a brief overview of the Consortium's activities in its first decade and a context for some of our current activities and future directions. The growth and success of the CSRC have been primarily driven by members' active participation and the development of goodwill and trust throughout our membership, which have facilitated novel collaborations across traditionally competitive or contentious stakeholder boundaries. The continued expansion of our base of participating academicians, industry experts, and regulators will define the Consortium's success in our second decade. It is our hope that sharing our endeavors to date will stimulate additional participation in the CSRC and also provide a model for other groups starting to develop similar collaborative forums.
Quintiles, Durham, NC. Electronic address: rick.turner@quintiles.com.
J Rick
JR
Turner
Lankenau Institute for Medical Research & Thomas Jefferson University, PA.
Peter R
PR
Kowey
Roche, New York, NY.
Ignacio
I
Rodriguez
Quintiles, Durham, NC.
Christopher H
CH
Cabell
AbbVie, North Chicago, IL.
Gary
G
Gintant
Duke University Medical Center and Duke Clinical Research Institute, Durham, NC.
Cynthia L
CL
Green
DIA, Washington, DC.
Barbara Lopez
BL
Kunz
Mortara Instrument, Milwaukee, WI.
Justin
J
Mortara
Stanford University, Palo Alto, CA.
Philip T
PT
Sager
US Food and Drug Administration, White Oak, MD.
Norman
N
Stockbridge
Eli Lilly and Company, Indianapolis, IN.
Theressa J
TJ
Wright
GlaxoSmithKline, Philadelphia, PA.
John
J
Finkle
Duke University Medical Center and Duke Clinical Research Institute, Durham, NC.
Mitchell W
MW
Krucoff
D035843:Biomedical Research; D002317:Cardiovascular Agents; D013504:Cardiovascular Surgical Procedures; D004869:Equipment Safety; D006801:Humans; D061214:Patient Safety; D055818:Public-Private Sector Partnerships; D014481:United States; D014486:United States Food and Drug Administration; D014495:Universities
D002317:Cardiovascular Agents