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Original Investigation | SurgeryRemission and Relapse of Dyslipidemia After Vertical Sleeve Gastrectomy vs Rouen Gastric Bypass in a Racially and Ethnically Diverse Population Karen J. Coleman, PhD,
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Gather data on safety and effectiveness of the products being compared
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Comparative safety and effectiveness refers to the analysis and evaluation of the safety and efficacy of different medical interventions or treatments by comparing them against one another in real-world settings.
Manufacturers and sponsors of health care products, including drugs and medical devices, are typically required to file comparative safety and effectiveness data as part of their regulatory submissions.
Filling out comparative safety and effectiveness typically involves submitting data from clinical studies, including safety reports, adverse events, and patient outcomes, along with an analysis comparing different treatment options.
The purpose of comparative safety and effectiveness is to inform healthcare providers and patients about the relative benefits and risks of different treatment options, helping to guide clinical decision-making and improve patient outcomes.
Information that must be reported includes study design, patient demographics, treatment protocols, safety data, efficacy outcomes, and any observed adverse events related to the treatments being compared.
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