title: Cardiovascular Safety Outcome Trials: A meeting report from the Cardiac Safety Research Consortium.
abstract: This White Paper provides a summary of presentations and discussions at a Cardiovascular Safety Outcome Trials Think Tank cosponsored by the Cardiac Safety Research Consortium, the US Food and Drug Administration, and the American College of Cardiology, held at American College of Cardiology's Heart House, Washington, DC, on February 19, 2014. Studies to assess cardiovascular (CV) risk of a new drug are sometimes requested by regulators to resolve ambiguous safety signals seen during its development or among other members of its class. Think Tank participants thought that important considerations in undertaking such studies were as follows: (1) plausibility-how likely it is that a possible signal indicating risk is real, based on strength of evidence, and/or whether a plausible mechanism of action for potential CV harm has been identified; (2) relevance-what relative and absolute CV risk would need to be excluded to determine that the drug had an acceptable benefit-to-risk balance for its use in the intended patient population; and (3) how plausibility and relevance influence the timing and approach to further safety assessment.
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA.
authors.forename: Philip T
authors.initials: PT
authors.lastname: Sager
authors.affiliation: ACI Clinical, Bala Cynwyd, PA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Seltzer
authors.affiliation: Quintiles, Inc, Durham, NC.
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
authors.affiliation: Intermountain Heart Institute, Salt Lake City, UT.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Anderson
authors.affiliation: Division of Cardiology/CPC Clinical Research, University of Colorado School of Medicine, Aurora, CO.
authors.forename: William R
authors.initials: WR
authors.lastname: Hiatt
authors.affiliation: Lankenau Medical Center, Philadelphia, PA.
authors.forename: Peter
authors.initials: P
authors.lastname: Kowey
authors.affiliation: Stanford Prevention Research Center, Stanford University, Palo Alto, CA.
authors.forename: Judith J
authors.initials: JJ
authors.lastname: Prochaska
authors.affiliation: Food and Drug Administration, Silver Spring MD.
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.affiliation: Cardiology Center, University of Connecticut School of Medicine, Farmington, CT. Electronic address: wwhite@uchc.edu.
authors.forename: William B
authors.initials: WB
authors.lastname: White
mesh_terms: D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003226:Congresses as Topic; D017277:Drug Approval / Q000379:methods*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D002317:Cardiovascular Agents