The estimand framework had implications in time to patient-reported outcomes deterioration analyses in cancer clinical trials

Author:

Cottone FrancescoORCID,Efficace Fabio,Cella David,Aaronson Neil K.,Giesinger Johannes M.ORCID,Bachet Jean-Baptiste,Louvet Christophe,Charton Emilie,Collins Gary S.,Anota AmelieORCID

Publisher

Elsevier BV

Subject

Epidemiology

Reference20 articles.

1. ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials,2021

2. Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials E9(R1),2019

3. US food and drug administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017;Fiero;Lancet Oncol,2019

4. Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?;Anota;Qual Life Res,2015

5. Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review;Charton;Qual Life Res,2020

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