Monitoring Overall Survival in Pivotal Trials in Indolent Cancers

Author:

Fleming Thomas R.1,Hampson Lisa V.2,Bharani-Dharan Bharani3ORCID,Bretz Frank2ORCID,Chakravartty Arunava3,Coroller Thibaud3,Koukouli Evanthia4,Wittes Janet5,Yateman Nigel2,Zuber Emmanuel2

Affiliation:

1. Department of Biostatistics, University of Washington, Seattle, WA

2. Novartis Pharma AG, Basel, Switzerland

3. Novartis Pharmaceuticals Corporation, East Hanover, NJ

4. Novartis Pharmaceuticals UK, London, UK

5. Wittes LLC, Washington, DC

Funder

National Institutes of Health

Publisher

Informa UK Limited

Reference37 articles.

1. Insights on the Robust Variance Estimator under Recurrent-Events Model

2. Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

3. Burdon A. J. Hampson L. V. and Jennison C. (2023) “Joint Modelling of Longitudinal and Time-to-Event Data Applied to Group Sequential Clinical Trials ” Available at https://arxiv.org/abs/2211.16138

4. When Can Intermediate Outcomes Be Used as Surrogate Outcomes?

5. EMA. (2019) “Guideline on the Investigation of Subgroups in Confirmatory Clinical Trials ” Available at https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf

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