Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials. Issue 2 (2015)

• Record Type: Journal Article
• Authors: Whicher, Danielle; Kass, Nancy; Faden, Ruth
• Is Part Of: Journal of law, medicine & ethics. Volume 43:Issue 2(2015)
• Page Start: 397
• Page End: 409
• Publication Date: 2015
• Subjects: Medical laws and legislation -- United States -- Periodicals; Medical care -- Law and legislation -- United States -- Periodicals; Medical ethics -- Periodicals; Jurisprudence -- Periodicals; Legislation, Medical -- Periodicals; Legislation, Nursing -- Periodicals; Ethics -- Periodicals; Forensic Medicine -- Periodicals; Nursing -- Periodicals; Medicine -- Periodicals; Societies -- Periodicals; Medical care -- Law and legislation; Medical ethics; Medical laws and legislation; United States; Periodicals; 344.73041
• DOI: 10.1111/jlme.12256
• Languages: English
• ISSNs: 1073-1105

Abstract

Abstract : Technological innovation has led to important advancements in medical care. Nonetheless, patients continue to receive many health services for which the evidence regarding whether the service is effective is inadequate. Recognizing the need for robust evidence to support clinical and health policy decision-making, increasing attention has focused on comparative effectiveness research (CER). To support such efforts and to underscore the public's interest in having such evidence, the federal government has recently devoted substantial resources to support CER. CER has been defined as "the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in "real world" settings." Understanding how different interventions work in the real world generally requires that CER studies be closely integrated with clinical practice. Further, although some CER questions can be answered with observational studies, generating robust evidence will, at times, require randomized controlled trials (RCTs).