Surrogate endpoints
Review of meta-analyses evaluating surrogate endpoints for overall survival in oncology
... and surrogate endpoints are often used ...of surrogate endpoints, specifically in ...of surrogate measures used in oncology studies and examined the extent of correlation between ...
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Validation of Surrogate Endpoints in Advanced Solid Tumors: Systematic Review of Statistical Methods, Results, and Implications for Policy Makers
... the surrogate and final ...the surrogate endpoints on the basis of IPD, the authors used joint models of the surrogate and the final endpoint as continuous bivariate normally distributed, 14 ...
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Time to review the role of surrogate endpoints in health policy: state of the art and the way forward
... low surrogate to final outcomes associations lead to highly uncertain incremental cost-effectiveness ...of surrogate evaluation tools and harmonisation of different approaches, particularly across the ...
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Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction
... appropriate surrogate end- point for the question at hand cannot restrict itself to a biologically plausible association between surrogate and clinical ...Furthermore, surrogate endpoints ...
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Validation of Surrogate Endpoints in Advanced Solid Tumors: Systematic Review of Statistical Methods, Results, and Implications for Policy Makers
... patient-relevant endpoints are available, for example in clinical trials that have terminated prematurely or for which data on the final endpoint are not fully ...from surrogate endpoints poses a ...
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Validation of Surrogate Endpoints in Advanced Solid Tumors: Systematic Review of Statistical Methods, Results, and Implications for Policy Makers
... orcid.org/0000-0002-6609-4287 et al. (6 more authors) (2014) Validation of Surrogate Endpoints in Advanced Solid Tumors: Systematic Review of Statistical Methods, Results, and Implications for Policy ...
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Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
... specific surrogate has a reliable ability to predict changes in meaningful ...hard endpoints have been fully recruited, and are ...of surrogate endpoints in ...
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Use of surrogate endpoints in healthcare policy : proposal for consistent adoption of a validation framework
... the surrogate endpoint and the final ...the surrogate and the final outcome, and the association between the effect of treatment on the surrogate and the final ...putative surrogate ...
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Surrogate endpoints, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease
... The 1962 requirement for adequate and well-controlled studies is currently satisfied by Surrogate end point trials for drug therapies of cardiovascular risk factors Although Sur- rogate [r] ...
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The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases
... of surrogate endpoints poses a risk for the approval of ineffective or unexpectedly harmful treat- ...of surrogate use for many life-threatening rare diseases because many rare biochemical disorders ...
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<p>Low Liver Density Is Linked to Cardiovascular Comorbidity in COPD: An ECLIPSE Cohort Analysis</p>
... non-invasive surrogate of fat in fi ltration, with lower liver densities re fl ecting more fat in fi ltration and a liver density of 40 Houns fi eld Units (HU) corresponding to a severe 30% fatty in fi ...Predictive ...
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Progression-free survival/time to progression as a potential surrogate for overall survival in HR+, HER2– metastatic breast cancer
... appropriate surrogate endpoints for ...a surrogate endpoint because it accounts for patients who die following tumor progression or following adverse events related to ...
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Mark versus Luke? Appropriate methods for the evaluation of public health interventions
... It seems plain that the mix of types of evidence for the evaluation of public health interventions will differ in a number of important respects from that customarily available in medical care. For example, within HTA, ...
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COPD association and repeatability of blood biomarkers in the ECLIPSE cohort
... lates poorly with both symptoms and other measures of disease progression [3]. Moreover it does not differenti- ate between the causes of airflow obstruction (i.e. small airways disease or emphysema) or identify the ...
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Ectopic fat accumulation in patients with COPD: an ECLIPSE substudy
... Predictive Surrogate Endpoints (ECLIPSE) cohort with a 3-year follow-up to address the following questions: 1) Is COPD associated with increased ectopic fat accumulation within the abdomen and in the ...
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Assessment of research waste part 1: an exemplar from examining study design, surrogate and clinical endpoints in studies of calcium intake and vitamin D supplementation
... study endpoints, which we think makes any conclusions more compelling than if the re- search areas or the study design and endpoints were assessed ...with surrogate endpoints extended well ...
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Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi arm phase I/II trial design
... of endpoints is clearer in oncology trials both because of a higher incidence and more well- defined surrogate endpoints, such as tumour response criteria ...immunogenicity endpoints without a ...
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Chronic obstructive pulmonary disease and exacerbations: Patient insights from the global Hidden Depths of COPD survey
... The incidence of comorbidities reported here is likely associated with the age and smoking characteristics of the population – over half of patients in our survey were current smokers. Comorbidities were common, and were ...
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Optimal organization of surrogacy contracts and underinvestment
... It has been seen that in many cases it is purely the monetary compensation paid to the surrogates that lures poor women into taking all kinds of risks, risks that they know little of. Majority of these women are ...
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The variability of p-values
... In practice, I suggest using B = 999 as in Examples 3 and 4, but B = 99 was used for some of the simulations in Section 4 (where only B = 999 results are reported), and the intervals performed reasonably well. For the ...
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