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
Placebo Control and Blinding in Randomized Trials of Procedural Interventions: A Systematic Review and Meta-Regression.
Sign Up to like & getrecommendations! Published in 2024 at "JAMA surgery"
DOI: 10.1001/jamasurg.2024.0718
Abstract: Importance Unlike medications, procedural interventions are rarely trialed against placebo prior to becoming accepted in clinical practice. When placebo-controlled trials are eventually conducted, procedural interventions may be less effective than previously believed. Objective To investigate… read more here.
Keywords: end; end points; procedural interventions; placebo ... See more keywords
Evaluation of Acarbose Bioequivalence in Healthy Chinese Populations Using Novel Pharmacodynamic End Points
Sign Up to like & getrecommendations! Published in 2024 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1362
Abstract: Acarbose is a widely used α‐glucosidase inhibitor for the management of postprandial hyperglycemia in patients with type 2 diabetes mellitus. Recent pilot studies on acarbose bioequivalence (BE) have successfully identified additional pharmacodynamic (PD) parameters as… read more here.
Keywords: glucose concentration; end points; serum glucose; concentration ... 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