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For handling intercurrent events in clinical trials, one of the strategies outlined in the ICH E9(R1) addendum targets the hypothetical scenario of non-occurrence of the intercurrent event. While this strategy is often implemented by setting data aft
Externí odkaz:
http://arxiv.org/abs/2409.10943
Autor:
Bell, James, Drury, Thomas, Mütze, Tobias, Pipper, Christian Bressen, Guizzaro, Lorenzo, Mitroiu, Marian, Rantell, Khadija Rerhou, Wolbers, Marcel, Wright, David
Estimands using the treatment policy strategy for addressing intercurrent events are common in Phase III clinical trials. One estimation approach for this strategy is retrieved dropout whereby observed data following an intercurrent event are used to
Externí odkaz:
http://arxiv.org/abs/2402.12850
Publikováno v:
Contemporary Clinical Trials Communications, Vol 38, Iss , Pp 101266- (2024)
Background: The estimands framework represents a significant innovation for the design, conduct, analysis, and interpretation of clinical trials. An aim of the framework is to increase precision and transparency on the handling of intercurrent events
Externí odkaz:
https://doaj.org/article/5d7639251c6f447cbe1647f822544dc9
Publikováno v:
In Contemporary Clinical Trials Communications April 2024 38
Autor:
Lasch, Florian1,2 (AUTHOR), Guizzaro, Lorenzo1,3 (AUTHOR), Pétavy, Frank1 (AUTHOR), Gallo, Ciro3 (AUTHOR)
Publikováno v:
Statistics in Biopharmaceutical Research. Apr-Jun2023, Vol. 15 Issue 2, p386-399. 14p.
Publikováno v:
In Journal of Clinical Epidemiology August 2020 124:106-117
Autor:
Diana Giannarelli, Lucia Del Mastro, Fabio Efficace, Vincenzo Montesarchio, Roberto Bordonaro, Silvia Riva, Jane Bryce, Francesco De Lorenzo, Laura Del Campo, Massimo Di Maio, Luciano Frontini, Lara Gitto, Elisabetta Iannelli, Claudio Jommi, Francesca Traclò, Concetta Maria Vaccaro, Ciro Gallo, Francesco Perrone, Camillo Porta, Vittorina Zagonel, Laura Arenare, Saverio Cinieri, Maria Carmela Piccirillo, Anna Gimigliano, Lorenzo Guizzaro, Daniela Barberio, Alessio Aligi Cogoni
Publikováno v:
BMJ Open, Vol 11, Iss 10 (2021)
Objectives To measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare.Setting Ten clinical oncological
Externí odkaz:
https://doaj.org/article/e9f3af75e2734075b922f079ada930a9
Autor:
Raimondo Di Liello, Ciro Gallo, Francesco Perrone, Laura Arenare, Paolo Chiodini, Maria Carmela Piccirillo, Piera Gargiulo, Lorenzo Guizzaro
Publikováno v:
BMJ Open, Vol 11, Iss 9 (2021)
A wave of new treatments and treatment combinations are becoming available for solid tumours. Trials performed to obtain registration establish a positive benefit-risk but unavoidably leave many questions unanswered on place-in-therapy and the relati
Externí odkaz:
https://doaj.org/article/7258f65af7c048648acf532791021893
Autor:
Daniele, Gennaro, Arenare, Laura, Scambia, Giovanni, Pisano, Carmela, Sorio, Roberto, Breda, Enrico, De Placido, Sabino, Savarese, Antonella, Ferrandina, Gabriella, Raspagliesi, Francesco, Panici, Pierluigi Benedetti, Ferro, Antonella, Rimanti, Anita, Cormio, Gennaro, Lorusso, Domenica, Cecere, Sabrina Chiara, Scalone, Simona, Marsico, Valentina Angela, Cardalesi, Cinzia, Cognetti, Francesco, Salutari, Vanda, Attademo, Laura, Guizzaro, Lorenzo, Schettino, Clorinda, Piccirillo, Maria Carmela, Perrone, Francesco, Gallo, Ciro, Pignata, Sandro
Publikováno v:
In Gynecologic Oncology July 2019 154(1):83-88