Zobrazeno 1 - 10
of 27
pro vyhledávání: '"Mouna Akacha"'
Autor:
Iván Díaz, Hana Lee, Emre Kıcıman, Edward J. Schenck, Mouna Akacha, Dean Follman, Debashis Ghosh
Publikováno v:
Journal of Clinical and Translational Science, Vol 7 (2023)
Abstract Objective: The United States Congress passed the 21st Century Cures Act mandating the development of Food and Drug Administration guidance on regulatory use of real-world evidence. The Forum on the Integration of Observational and Randomize
Externí odkaz:
https://doaj.org/article/5386275642b143829954ba37150f6aa0
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
Autor:
Mouna Akacha, Christian Bartels, Björn Bornkamp, Frank Bretz, Neva Coello, Thomas Dumortier, Michael Looby, Oliver Sander, Heinz Schmidli, Jean‐Louis Steimer, Camille Vong
Publikováno v:
CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 4, Pp 279-282 (2021)
Externí odkaz:
https://doaj.org/article/3b8ad428c84940ed841522ba4471f1f8
Autor:
Mouna Akacha, Tianmeng Lyu
Publikováno v:
Statistics in Biopharmaceutical Research. 15:116-118
Publikováno v:
Statistics in medicineREFERENCES. 41(28)
Publikováno v:
Statistics in Biopharmaceutical Research. 15:238-248
Treatment effects on recurrent events are of primary clinical interest in many diseases such as asthma, multiple sclerosis or chronic heart failure. When death makes it impossible to experience fur...
Autor:
Kapildeb Sen, Frank Bretz, Evgeny Degtyarev, Yiyun Zhang, Bjoern Bornkamp, Lisa V. Hampson, David Lebwohl, Mouna Akacha, Antonella Maniero, Emmanuel Zuber
Publikováno v:
JCO precision oncology. 3
The diversity of patient journeys can raise fundamental questions regarding the evaluation of drug effects in clinical trials to inform clinical practice. When defining the treatment effect of interest in a trial, the researcher needs to account for
Autor:
Mouna Akacha
Publikováno v:
CHANCE. 32:12-17
The first time I was about to make a presentation about estimands and their role in clinical trials, a colleague took me aside and said that “there is a typo in your title slide—should it say estim...
Autor:
Emmanuel Zuber, Francesca Callegari, Peter Quarg, Mouna Akacha, Shaloo Pandhi, Florian Von Raison
Publikováno v:
Statistics in Biopharmaceutical Research. 12:39-44
An estimand clearly defines the target treatment effect to be estimated in a clinical trial. A recently published draft International Conference on Harmonization E9 addendum introduces the concept ...
Autor:
Norman Stockbridge, Bruce Binkowitz, Mouna Akacha, H. M. James Hung, Guenther Mueller-Velten, Brian Claggett
Publikováno v:
Therapeutic Innovation & Regulatory Science. 53:387-397
Serious and chronic health conditions such as cardiovascular diseases (CVDs) are posing challenges to the health system. Recently clinical trials in these fields have focused on composite endpoints that take into account both disease-related mortalit