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
Assessment of Surrogate End Point Trends in Clinical Trials to Approve Oncology Drugs From 2001 to 2020 in Japan
Sign Up to like & getrecommendations! Published in 2023 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2023.8875
Abstract: Key Points Question How often are surrogate end points used to support the approval of anticancer drugs, and are confirmatory studies that use overall survival as an end point conducted in Japan? Findings In this… read more here.
Keywords: oncology; end point; surrogate end; end points ... See more keywords
Amyotrophic Lateral Sclerosis Clinical Trials and Interpretation of Functional End Points and Fluid Biomarkers: A Review.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA neurology"
DOI: 10.1001/jamaneurol.2022.3282
Abstract: Importance Clinical trial activity in amyotrophic lateral sclerosis (ALS) is dramatically increasing; as a result, trial modifications have been introduced to improve efficiency, outcome measures have been reassessed, and considerable discussion about the level of… read more here.
Keywords: lateral sclerosis; end points; primary outcome; amyotrophic lateral ... See more keywords
Composite and multicomponent end points in clinical trials.
Sign Up to like & getrecommendations! Published in 2017 at "Statistics in medicine"
DOI: 10.1002/sim.7386
Abstract: In January 2017, the FDA released the draft guidance to industry on multiple end points in clinical trials. A class of multiplicity problems arise from the testing of individual or subset of components of a… read more here.
Keywords: end points; end; clinical trials; composite multicomponent ... See more keywords
Location monitoring approach: multiple mix-zones with location privacy protection based on traffic flow over road networks
Sign Up to like & getrecommendations! Published in 2017 at "Multimedia Tools and Applications"
DOI: 10.1007/s11042-017-4469-4
Abstract: Nowadays communication by using mobile vehicle getting popularity and user experience map services like Google maps to reach at the destination. It is also clear that map services user have to reveal important information like… read more here.
Keywords: map services; location privacy; location; end points ... See more keywords
Progression-Free Survival as a Surrogate for Overall Survival in Clinical Trials of Targeted Therapy in Advanced Solid Tumors
Sign Up to like & getrecommendations! Published in 2017 at "Drugs"
DOI: 10.1007/s40265-017-0728-y
Abstract: Over the past 15 years, targeted therapy has revolutionized the systemic treatment of cancer. In parallel, there has been a growing debate on the choice of end points in clinical trials in oncology. This debate basically… read more here.
Keywords: end points; targeted therapy; surrogate; clinical trials ... See more keywords
Fate of degraded pollutants in waste gas biofiltration: An overview of carbon end-points.
Sign Up to like & getrecommendations! Published in 2019 at "Biotechnology advances"
DOI: 10.1016/j.biotechadv.2018.09.002
Abstract: The fate of the carbon from degraded pollutants in biofiltration is not well understood. The issue of missing carbon needs to be addressed quantitatively to better understand and model biofilter performance. Elucidating the various carbon… read more here.
Keywords: carbon; end points; biofiltration; carbon end ... See more keywords
Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative.
Sign Up to like & getrecommendations! Published in 2020 at "European journal of cancer"
DOI: 10.1016/j.ejca.2020.02.009
Abstract: BACKGROUND The variability of definitions for time-to-event (TTE) end-points impacts the conclusions of randomised clinical trials (RCTs). The Definition for the Assessment of Time-to-event Endpoints in CANcer (DATECAN) initiative aims to provide consensus definitions for… read more here.
Keywords: end points; end; time event; cancer ... See more keywords
Contemporary outcomes of thoracofemoral bypass
Sign Up to like & getrecommendations! Published in 2019 at "Journal of Vascular Surgery"
DOI: 10.1016/j.jvs.2018.07.053
Abstract: Objective Thoracofemoral bypass (TFB) is an alternative to aortofemoral bypass (AFB) or extra‐anatomic bypass for severe aortoiliac occlusive disease (AIOD). TFB may be particularly useful in select patients with concurrent visceral aortic branch vessel disease,… read more here.
Keywords: bypass; limb; end points; graft ... See more keywords
The eventually distance minimizing rays in moduli spaces
Sign Up to like & getrecommendations! Published in 2018 at "Acta Mathematica Scientia"
DOI: 10.1016/s0252-9602(18)30795-1
Abstract: Abstract The eventually distance minimizing ray (EDM ray) in moduli spaces of the Riemann surfaces of analytic finite type with 3g + n − 3 > 0 is studied, which was introduced by Farb and… read more here.
Keywords: edm rays; distance minimizing; end points; moduli spaces ... See more keywords