Benefit-risk paradigm for clinical trial design of obesity devices: FDA proposal
Author:
Publisher
Springer Science and Business Media LLC
Subject
Surgery
Link
http://link.springer.com/content/pdf/10.1007/s00464-012-2724-3.pdf
Reference16 articles.
1. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf . Accessed 28 Mar 2012
2. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm286235.htm2 . Accessed 10–11 May 2012
3. Appel LJ, Clark JM, Yeh HC et al (2011) Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med 365:1959–1968
4. Bogers RP, Bemelmans WJ, Hoogenveen RT et al (2007) Association of overweight with increased risk of coronary heart disease partly independent of blood pressure and cholesterol levels: a meta-analysis of 21 cohort studies including more than 300,000 persons. Arch Intern Med 167:1720–1728
5. Crémieux PY, Ledoux S, Clerici C et al (2010) The impact of bariatric surgery on comorbidities and medication use among obese patients. Obes Surg 20:861–870
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