Zobrazeno 1 - 10
of 446
pro vyhledávání: '"P Van Lancker"'
The ICH E9 (R1) addendum on estimands, coupled with recent advancements in causal inference, has prompted a shift towards using model-free treatment effect estimands that are more closely aligned with the underlying scientific question. This represen
Externí odkaz:
http://arxiv.org/abs/2409.11162
In May 2023, the U.S. Food and Drug Administration (FDA) released guidance for industry on "Adjustment for Covariates in Randomized Clinical Trials for Drugs and Biological Products". Covariate adjustment is a statistical analysis method for improvin
Externí odkaz:
http://arxiv.org/abs/2404.11150
There has been a growing interest in covariate adjustment in the analysis of randomized controlled trials in past years. For instance, the U.S. Food and Drug Administration recently issued guidance that emphasizes the importance of distinguishing bet
Externí odkaz:
http://arxiv.org/abs/2306.05823
Autor:
Lore Van Herreweghe, Wim Van Lancker
Publikováno v:
Frontiers in Public Health, Vol 12 (2024)
Externí odkaz:
https://doaj.org/article/a044025880b748ba8e4c6b41fe420185
Autor:
Lore Van Herreweghe, Wim Van Lancker
Publikováno v:
Frontiers in Public Health, Vol 12 (2024)
IntroductionIntergenerational support is an important determinant of mental health. Due to limited access to formal care, the role of the family as provider of support became more prominent during the COVID-19 pandemic. To date, it remains unclear ho
Externí odkaz:
https://doaj.org/article/8eb0809013664e06b7d4bc5db3061f05
Autor:
Rinaldo Bellomo, John Patava, Ruth Van Lancker, Nathalie Layios, Marijke Peetermans, Mark Plummer, Rachid Attou, Robert McNamara, Andrew Udy, Bradley Wibrow, Adam Deane, Edward Litton, Marcel Tanudji, Fuhong Su, Zhang Zhong, Linda Shi, Li Ning
Publikováno v:
Pharmacology Research & Perspectives, Vol 12, Iss 5, Pp n/a-n/a (2024)
Abstract Increased circulating histones correlate with sepsis severity and are a potential therapeutic target. Pre‐clinical studies showed benefit with a histone‐neutralizing polyanion molecule (STC3141). We aimed to investigate the safety, toler
Externí odkaz:
https://doaj.org/article/da0fa7c176b54328a4be40fcea383aa3
Autor:
Calderazzo, Silvia, Tarima, Sergey, Reid, Carissa, Flournoy, Nancy, Friede, Tim, Geller, Nancy, Rosenberger, James L, Stallard, Nigel, Ursino, Moreno, Vandemeulebroecke, Marc, Van Lancker, Kelly, Zohar, Sarah
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive and unprecedented initiation of clinical research, it has also led to c
Externí odkaz:
http://arxiv.org/abs/2206.11238
Autor:
Van Lancker, Kelly, Tarima, Sergey, Bartlett, Jonathan, Bauer, Madeline, Bharani-Dharan, Bharani, Bretz, Frank, Flournoy, Nancy, Michiels, Hege, Parra, Camila Olarte, Rosenberger, James L, Cro, Suzie
The COVID-19 pandemic continues to affect the conduct of clinical trials globally. Complications may arise from pandemic-related operational challenges such as site closures, travel limitations and interruptions to the supply chain for the investigat
Externí odkaz:
http://arxiv.org/abs/2202.03531
In clinical trials, there is potential to improve precision and reduce the required sample size by appropriately adjusting for baseline variables in the statistical analysis. This is called covariate adjustment. Despite recommendations by regulatory
Externí odkaz:
http://arxiv.org/abs/2201.12921
The problem of how to best select variables for confounding adjustment forms one of the key challenges in the evaluation of exposure effects in observational studies, and has been the subject of vigorous recent activity in causal inference. A major d
Externí odkaz:
http://arxiv.org/abs/2112.00172