Selection of Endpoints for Clinical Studies of Ophthalmic Drugs
Регуляторные исследования и экспертиза лекарственных средств, 2021 Until now, there have been no effective treatments for some ophthalmic diseases that have high social significance. Development of therapeutic approaches to such diseases may be complicated due to challenges in diagnosis and selection of clinical trial ...
M. O. Komarova
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Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward. [PDF]
EClinicalMedicineMittal A +4 more
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Surrogate Endpoints: CONSORT and SPIRIT Extensions. [PDF]
J Dent ResSchwendicke F, Jakubovics NS.
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Cardiovascular MRI in clinical trials: expanded applications through novel surrogate endpoints [PDF]
, 2011 Recent advances in cardiovascular magnetic resonance (CMR) now allow the accurate and reproducible measurement of many aspects of cardiac and vascular structure and function, with prognostic data emerging for several key imaging biomarkers.
Ashby, D +3 more
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Options for basing Dietary Reference Intakes (DRIs) on chronic disease endpoints: report from a joint US-/Canadian-sponsored working group. [PDF]
, 2016 Dietary Reference Intakes (DRIs) are used in Canada and the United States in planning and assessing diets of apparently healthy individuals and population groups.
Ard, Jamy +15 more
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Bayesian meta-analytical methods to incorporate multiple surrogate endpoints in drug development process. [PDF]
, 2015 A number of meta-analytical methods have been proposed that aim to evaluate surrogate endpoints. Bivariate meta-analytical methods can be used to predict the treatment effect for the final outcome from the treatment effect estimate measured on the ...
Abrams, KR +3 more
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The 6-minute walk test and other endpoints in Duchenne muscular dystrophy: longitudinal natural history observations over 48 weeks from a multicenter study. [PDF]
, 2013 IntroductionDuchenne muscular dystrophy (DMD) subjects ≥5 years with nonsense mutations were followed for 48 weeks in a multicenter, randomized, double-blind, placebo-controlled trial of ataluren.
Abresch, R Ted +12 more
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A perfect correlate does not a surrogate make
BMC Medical Research Methodology, 2003 Background There is common belief among some medical researchers that if a potential surrogate endpoint is highly correlated with a true endpoint, then a positive (or negative) difference in potential surrogate endpoints between randomization groups ...
Kramer Barnett S, Baker Stuart G
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The attachment system and physiology in adulthood: normative processes, individual differences, and implications for health. [PDF]
, 2014 Attachment theory provides a conceptual framework for understanding intersections between personality and close relationships in adulthood. Moreover, attachment has implications for stress-related physiology and physical health.
Ainsworth +88 more
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Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences [PDF]
Brazilian Oral Research, 2020 Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the
PEDRAZZI Vinicius +5 more
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