Results 61 to 70 of about 510,312 (368)

A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses

open access: yesJNCI Cancer Spectrum, 2019
Background Meta-analysis of randomized controlled trials (RCTs) has been widely conducted for the evaluation of surrogate endpoints in oncology, but little attention has been given to the adequacy of reporting and interpretation.
W. Xie   +8 more
semanticscholar   +1 more source

Applications of neuroimaging to disease-modification trials in Alzheimer's disease. [PDF]

open access: yes, 2009
Critical to development of new therapies for Alzheimer's disease (AD) is the ability to detect clinical or pathological change over time. Clinical outcome measures typically used in therapeutic trials have unfortunately proven to be relatively variable ...
Aisen, Paul S   +5 more
core   +2 more sources

Performance of GFR Slope as a Surrogate Endpoint for Kidney Disease Progression in Clinical Trials: A Statistical Simulation.

open access: yesJournal of the American Society of Nephrology, 2019
BACKGROUND Randomized trials of CKD treatments traditionally use clinical events late in CKD progression as end points. This requires costly studies with large sample sizes and long follow-up.
T. Greene   +14 more
semanticscholar   +1 more source

Evaluating Candidate Principal Surrogate Endpoints

open access: yesBiometrics, 2008
Summary Frangakis and Rubin (2002, Biometrics 58, 21–29) proposed a new definition of a surrogate endpoint (a “principal” surrogate) based on causal effects. We introduce an estimand for evaluating a principal surrogate, the causal effect predictiveness (CEP) surface, which quantifies how well causal treatment effects on the biomarker predict causal ...
Gilbert, Peter B., Hudgens, Michael G.
openaire   +3 more sources

Evidence regarding clinical use of microvolt T-wave alternans [Accuracy of microvolt T-wave alternans testing] [PDF]

open access: yes, 2011
Background: Microvolt T-wave alternans (MTWA) testing in many studies has proven to be a highly accurate predictor of ventricular tachyarrhythmic events (VTEs) in patients with risk factors for sudden cardiac death (SCD) but without a prior history of ...
Cohen, Richard J.   +2 more
core  

Pathogenic Germline PALB2 and RAD50 Variants in Patients With Relapsed Ewing Sarcoma

open access: yesPediatric Blood &Cancer, EarlyView.
ABSTRACT Approximately 10% of patients with Ewing sarcoma (EwS) have pathogenic germline variants. Here, we report two cases: first, a novel germline pathogenic variant in partner and localizer of BRCA2 (PALB2) in a patient with a late EwS relapse. Its impact on homologous recombination is demonstrated, and breast cancer risk is discussed.
Molly Mack   +12 more
wiley   +1 more source

What can we learn from SOCRATES: more questions than answers? [PDF]

open access: yes, 2017
This editorial refers to ‘Vericiguat in patients with worsening chronic heart failure and preserved ejection fraction: results of the SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED EF (SOCRATES-PRESERVED) Study’, by B ...
Cleland, John G.F., Mueller, Christian
core   +1 more source

A modified weighted log-rank test for confirmatory trials with a high proportion of treatment switching [PDF]

open access: yes, 2020
In confirmatory cancer clinical trials, overall survival (OS) is normally a primary endpoint in the intention-to-treat (ITT) analysis under regulatory standards. After the tumor progresses, it is common that patients allocated to the control group switch
Bore, Alexander   +3 more
core   +2 more sources

Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

open access: yesBMJ Open, 2022
Introduction Randomised controlled trials (RCTs) may use surrogate endpoints as substitutes and predictors of patient-relevant/participant-relevant final outcomes (eg, survival, health-related quality of life).
Martin Offringa   +10 more
doaj   +1 more source

Comparing Biomarkers as Principal Surrogate Endpoints [PDF]

open access: yesBiometrics, 2011
Recently a new definition of surrogate endpoint, the "principal surrogate," was proposed based on causal associations between treatment effects on the biomarker and on the clinical endpoint. Despite its appealing interpretation, limited research has been conducted to evaluate principal surrogates, and existing methods focus on risk models that consider
Huang, Ying, Gilbert, Peter B.
openaire   +3 more sources

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