US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
Sign Up to like & getrecommendations! Published in 2019 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2019.5451
Abstract: Importance Regulatory and scientific guidelines stipulate that indirect, surrogate measures of patient benefit, such as a change in microbial culture status, should be used as primary end points only in pivotal trials of chronic conditions… read more here.
Keywords: primary end; end points; surrogate measures; anti infective ... See more keywords
Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.45847
Abstract: Key Points Question What is the concordance among sample size, primary end points, results for primary end points, and interpretations described in preprints of clinical studies posted on medRxiv that are subsequently published in peer-reviewed… read more here.
Keywords: published peer; clinical studies; primary end; peer reviewed ... See more keywords
Incidence of Primary End Point Changes Among Active Cancer Phase 3 Randomized Clinical Trials
Sign Up to like & getrecommendations! Published in 2023 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2023.13819
Abstract: This cross-sectional study assesses the frequency of reporting of primary end point changes among active oncology phase 3 randomized clinical trials. read more here.
Keywords: among active; end point; point changes; primary end ... See more keywords
Clinical profile and outcome of patients with chronic inflammatory arthritis and metabolic syndrome
Sign Up to like & getrecommendations! Published in 2020 at "Internal and Emergency Medicine"
DOI: 10.1007/s11739-020-02520-y
Abstract: Systemic chronic inflammation may favor the onset of metabolic syndrome (MetS) which represents a risk factor for CV events. Rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) are disorders with high prevalence of… read more here.
Keywords: psa; risk; primary end; metabolic syndrome ... See more keywords
Duration of asymptomatic status and outcomes following carotid endarterectomy and carotid artery stenting in the Carotid Revascularization Endarterectomy vs Stenting Trial.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of vascular surgery"
DOI: 10.1016/j.jvs.2018.09.054
Abstract: BACKGROUND Most carotid revascularization studies define asymptomatic as symptom-free for more than 180 days; however, it is unknown if intervention carries similar risk among those currently asymptomatic but with previous symptoms (PS) vs those who were… read more here.
Keywords: carotid revascularization; years primary; primary end; end point ... See more keywords
Ripple-AT Study.
Sign Up to like & getrecommendations! Published in 2019 at "Circulation: Arrhythmia and Electrophysiology"
DOI: 10.1161/circep.118.007394
Abstract: BACKGROUND Ripple mapping (RM) is an alternative approach to activation mapping of atrial tachycardia (AT) that avoids electrogram annotation. We tested whether RM is superior to conventional annotation based local activation time (LAT) mapping for… read more here.
Keywords: lat mapping; end point; ripple; lesion set ... See more keywords
The 6-min walk test as a primary end-point in interstitial lung disease
Sign Up to like & getrecommendations! Published in 2022 at "European Respiratory Review"
DOI: 10.1183/16000617.0087-2022
Abstract: There is a need for clinical trial end-points to better assess how patients feel and function, so that interventions can be developed which alleviate symptoms and improve quality of life. Use of 6-min walk test… read more here.
Keywords: end point; disease; primary end; min walk ... See more keywords