title: Criteria for standard versus experimental therapy.
abstract: This paper demarcates the boundaries between experimental and standard therapy and the influence of this division on policy, payment, and practice. It proposes a new category, crossover therapy, to deal with the many therapies that fall in between. It establishes four criteria to separate these categories: (1) the populations and conditions for which use is helpful; (2) the expected outcomes of care; (3) the skill, personnel, and site requirements and the economic, ethical, and legal understandings essential for use; and (4) the level of knowledge needed to certify that prospective users can apply it well. The paper then explores the use of experimental therapy in desperate situations and of standard therapies in new areas and gives policy recommendations to facilitate these actions.
authors.forename: S J
authors.initials: SJ
authors.lastname: Reiser
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D018592:Cross-Over Studies; D035082:Federal Government; D033161:Government Regulation; D006291:Health Policy / Q000191:economics; D007349:Insurance, Health, Reimbursement / Q000191:economics / Q000592:standards*; D038622:Internationality; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D035501:Uncertainty; D014481:United States