This JAMA Guide to Statistics and Methods reviews the use of composite outcome measures in clinical trials and discusses how their use should influence interpretations of trial results.
This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.
This study uses public US Food and Drug Administration (FDA) data to characterize drug trials used to obtain FDA accelerated approval and to describe the existence, timing, and characteristics of postapproval trials mandated by the FDA as part of the accelerated approval decision.
This randomized clinical trial investigates the efficacy of oral iron supplementation for improvement of exercise capacity in adult patients with heart failure with reduced left ventricular ejection fraction.
This Viewpoint details why hemoglobin A1c levels are no longer a valid surrogate outcome for assessing the effects of diabetes treatments.
This randomized clinical trial investigates whether cardiovascular magnetic resonance–guided care is superior to National Institute for Health and Care Excellence guidelines–directed care and myocardial perfusion scintigraphy–guided care in reducing the occurrence of unnecessary angiography among patients with suspected coronary heart disease.
This JAMA Guide to Statistics and Methods discusses how to interpret the results of clinical trials that are stopped early based on formal, prespecified stopping rules.
This 2-stage randomized clinical trial compared lipid-lowering efficacy of 2 nonstatin therapies, ezetimibe and evolocumab, among patients with uncontrolled low-density lipoprotein cholesterol levels and intolerance to 2 or more statins.
This Viewpoint describes the rationale behind an FDA and NIH effort to develop a glossary of common terms and definitions for biomarkers and surrogate endpoints.
This noninferiority trial compares the effects of a fixed ratio of insulin degludec/liraglutide vs up-titration of insulin glargine on glycated hemoglobin levels among patients with uncontrolled type 2 diabetes treated with glargine and metformin.
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