title: Modeling for health care and other policy decisions: uses, roles, and validity.
abstract: The role of models to support recommendations on the cost-effective use of medical technologies and pharmaceuticals is controversial. At the heart of the controversy is the degree to which experimental or other empirical evidence should be required prior to model use. The controversy stems in part from a misconception that the role of models is to establish truth rather than to guide clinical and policy decisions. In other domains of public policy that involve human life and health, such as environmental protection and defense strategy, models are generally accepted as decision aids, and many models have been formally incorporated into regulatory processes and governmental decision making. We formulate an analytical framework for evaluating the role of models as aids to decision making. Implications for the implementation of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) are derived from this framework.
authors.affiliation: Program on the Economic Evaluation of Medical Technology, Harvard Center for Risk Analysis, Harvard School of Public Health, 718 Huntington Avenue, Boston, MA 02115, USA. mcw@hsph.harvard.edu
authors.forename: M C
authors.initials: MC
authors.lastname: Weinstein
authors.forename: E L
authors.initials: EL
authors.lastname: Toy
authors.forename: E A
authors.initials: EA
authors.lastname: Sandberg
authors.forename: P J
authors.initials: PJ
authors.lastname: Neumann
authors.forename: J S
authors.initials: JS
authors.lastname: Evans
authors.forename: K M
authors.initials: KM
authors.lastname: Kuntz
authors.forename: J D
authors.initials: JD
authors.lastname: Graham
authors.forename: J K
authors.initials: JK
authors.lastname: Hammitt
mesh_terms: D017402:Chlorofluorocarbons; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D003657:Decision Making; D018795:Device Approval; D017277:Drug Approval / Q000191:economics / Q000379:methods*; D017850:Economics, Pharmaceutical; D015276:Health Care Rationing; D006801:Humans; D008962:Models, Theoretical; D010575:Pesticides; D011050:Policy Making; D015203:Reproducibility of Results; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods* / Q000592:standards; D014481:United States; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration
chemical_list: D017402:Chlorofluorocarbons; D010575:Pesticides