Estimands for overall survival in clinical trials with treatment switching in oncology-Reference-Cited by-同舟云学术

Estimands for overall survival in clinical trials with treatment switching in oncology

Published:2021-10-03 Issue:1 Volume:21 Page:150-162
ISSN:1539-1604
Container-title:Pharmaceutical Statistics
language:en
Short-container-title:Pharmaceutical Statistics

Author:

Manitz Juliane¹^ORCID,Kan‐Dobrosky Natalia²,Buchner Hannes³,Casadebaig Marie‐Laure⁴,Degtyarev Evgeny⁵,Dey Jyotirmoy⁶,Haddad Vincent⁷,Jie Fei⁸,Martin Emily¹,Mo Mindy⁹,Rufibach Kaspar¹⁰^ORCID,Shentu Yue¹¹,Stalbovskaya Viktoriya¹²,Tang Rui¹³,Yung Godwin¹⁴,Zhou Jiangxiu¹⁵

Affiliation:

1. Global Biostatistics EMD Serono Billerica Massachusetts USA

2. Statistical Science PPD Wilmington North Carolina USA

3. Biostatistics and Data Science Staburo GmbH Munich Germany

4. GBDS BMS Boudry Switzerland

5. Clinical Development and Analytics Novartis Basel Switzerland

6. Data and Statistical Sciences AbbVie Inc. North Chicago Illinois USA

7. Oncology Biometric AstraZeneca Cambridge UK

8. Biostatistics and Data Management Daiichi Sankyo Inc Basking Ridge New Jersey USA

9. Oncology Clinical Statistics US Bayer Whippany New Jersey USA

10. Methods, Collaboration, and Outreach F. Hoffmann‐La Roche Ltd Basel Switzerland

11. Biostatistics and Research Decision Sciences Merck & Co., Inc. Kenilworth New Jersey USA

12. Clinical Development Merus Utrecht The Netherlands

13. Global Biometric Servier Pharmaceuticals Boston Massachusetts USA

14. Methods, Collaboration, and Outreach Genentech San Francisco California USA

15. Biostatistics GSK Collegeville Pennsylvania USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pst.2158

Reference37 articles.

1. International Council for Harmonisation of Technical Requirements for Human Use (ICH).E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials.https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf.

2. A randomised, double-blind phase III study of pazopanib in patients with advanced and/or metastatic renal cell carcinoma: Final overall survival results and safety update

3. Final overall survival (OS) analysis with modeling of crossover impact in the phase III GRID trial of regorafenib vs placebo in advanced gastrointestinal stromal tumors (GIST).

4. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

5. Relationship between costs and clinical benefits of new cancer medicines in Australia, France, the UK, and the US

Cited by 12 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. End points in clinical trials in diffuse large B-cell lymphoma: time for more dialogue?;Future Oncology;2024-06-18

2. Treatment-Switching Adjustment of Overall Survival in CheckMate 227 Part 1 Evaluating First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy for Metastatic Nonsmall Cell Lung Cancer;Clinical Lung Cancer;2024-06

3. The future of clinical trials—goals, ideas, and discussion;memo - Magazine of European Medical Oncology;2024-04-18

4. Time‐to‐event estimands and loss to follow‐up in oncology in light of the estimands guidance;Pharmaceutical Statistics;2024-03-29

5. [Special issue PRO] Considering endpoints for comparative tolerability of cancer treatments using patient report given the estimand framework;Journal of Biopharmaceutical Statistics;2024-02-15