title: Integrating quality into the cycle of therapeutic development.
abstract: The quality of healthcare, particularly as reflected in current practice versus the available evidence, has become a major focus of national health policy discussions. Key components needed to provide quality care include: 1) development of quality indicators and performance measures from specific practice guidelines, 2) better ways to disseminate such guidelines and measures, and 3) development of support tools to promote standardized practice. Although rational decision-making and development of practice guidelines have relied upon results of randomized trials and outcomes studies, not all questions can be answered by randomized trials, and many treatment decisions necessarily reflect physiology, intuition, and experience when treating individuals. Debate about the role of "evidence-based medicine" also has raised questions about the value of applying trial results in practice, and some skepticism has arisen about whether advocated measures of clinical effectiveness, the basic definition of quality, truly reflect a worthwhile approach to improving medical practice. We provide a perspective on this issue by describing a model that integrates quantitative measurements of quality and performance into the development cycle of existing and future therapeutics. Such a model would serve as a basic approach to cardiovascular medicine that is necessary, but not sufficient, to those wishing to provide the best care for their patients.
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina, USA. calif001@mc.duke.edu
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Gibbons
authors.forename: Arthur
authors.initials: A
authors.lastname: Garson
authors.forename: Ralph G
authors.initials: RG
authors.lastname: Brindis
authors.forename: George A
authors.initials: GA
authors.lastname: Beller
authors.forename: Sidney C
authors.initials: SC
authors.lastname: Smith
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D011787:Quality of Health Care / Q000592:standards; D012106:Research / Q000592:standards; D012196:Review Literature as Topic