Zobrazeno 1 - 10
of 341
pro vyhledávání: '"Estimands"'
Publikováno v:
Trials, Vol 25, Iss 1, Pp 1-10 (2024)
Abstract Background Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estimation methods complica
Externí odkaz:
https://doaj.org/article/342331141aa04ef1a8c6e400a9fe8aa9
Akademický článek
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Autor:
Gerd Rippin
Publikováno v:
Frontiers in Drug Safety and Regulation, Vol 3 (2024)
The estimand framework as defined by the ICH E9(R1) addendum aims to clearly define “the treatment effect reflecting the clinical question posed by the trial objective”. It intends to achieve this goal of a clear definition by specifying the 5 es
Externí odkaz:
https://doaj.org/article/4c9fce2b7112479f8db608fcbb1be7c7
Akademický článek
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Publikováno v:
Stats, Vol 5, Iss 4, Pp 1254-1270 (2022)
Propensity score (PS) based methods, such as matching, stratification, regression adjustment, simple and augmented inverse probability weighting, are popular for controlling for observed confounders in observational studies of causal effects. More re
Externí odkaz:
https://doaj.org/article/98f5383fc2224f798ee541db73e89391
Autor:
Corinne Jamoul, Laurence Collette, Elisabeth Coart, Koenraad D’Hollander, Tomasz Burzykowski, Everardo D. Saad, Marc Buyse
Publikováno v:
BMC Medical Research Methodology, Vol 22, Iss 1, Pp 1-10 (2022)
Abstract Background Missing data may lead to loss of statistical power and introduce bias in clinical trials. The Covid-19 pandemic has had a profound impact on patient health care and on the conduct of cancer clinical trials. Although several endpoi
Externí odkaz:
https://doaj.org/article/de73c70f1fb345dbb3320e5b12c3a082
Autor:
Helle Lynggaard, James Bell, Christian Lösch, Amel Besseghir, Khadija Rantell, Volker Schoder, Vivian Lanius
Publikováno v:
Trials, Vol 23, Iss 1, Pp 1-15 (2022)
Abstract Clinical study protocols are the foundation of good clinical studies. Prospective and multidisciplinary collaboration that pays attention to the design of all components of the study protocol can ensure that a clinical study will answer the
Externí odkaz:
https://doaj.org/article/5bcd4a8937fe437cb3502ec61c52e7a2
Akademický článek
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Publikováno v:
Trials, Vol 23, Iss 1, Pp 1-17 (2022)
Abstract Background It has long been advised to account for baseline covariates in the analysis of confirmatory randomised trials, with the main statistical justifications being that this increases power and, when a randomisation scheme balanced cova
Externí odkaz:
https://doaj.org/article/57219ce60f6f4632934636daa4019bb5
Autor:
Lauren E. Dang, Susan Gruber, Hana Lee, Issa J. Dahabreh, Elizabeth A. Stuart, Brian D. Williamson, Richard Wyss, Iván Díaz, Debashis Ghosh, Emre Kıcıman, Demissie Alemayehu, Katherine L. Hoffman, Carla Y. Vossen, Raymond A. Huml, Henrik Ravn, Kajsa Kvist, Richard Pratley, Mei-Chiung Shih, Gene Pennello, David Martin, Salina P. Waddy, Charles E. Barr, Mouna Akacha, John B. Buse, Mark van der Laan, Maya Petersen
Publikováno v:
Journal of Clinical and Translational Science, Vol 7 (2023)
Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and indus
Externí odkaz:
https://doaj.org/article/1b066ab2c2c342e3b214a06e4b384ce1