Adaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success-Reference-Cited by-同舟云学术

Adaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success

Published:2016-07-02 Issue:3 Volume:8 Page:237-247
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Chen Cong¹,Li Nicole¹,Shentu Yue¹,Pang Lei²,Beckman Robert A.²

Affiliation:

1. Biostatistics and Research Decision Sciences, Merck Research Laboratories, Upper Gwynedd, PA, USA

2. Departments of Oncology and Biostatistics, Bioinformatics, and Biomathematics, Lombardi Comprehensive Cancer Center and Innovation Center for Biomedical Informatics, Georgetown University Medical Center, Washington, DC, USA

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2016.1173582

Reference19 articles.

1. Integrating predictive biomarkers and classifiers into oncology clinical development programmes

2. Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: General Concepts

3. Hypothesis Testing in a Confirmatory Phase III Trial With a Possible Subset Effect

4. Marker Sequential Test (MaST) design

Cited by 16 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. Adaptive Endpoints Selection with Application in Rare Disease;Statistics in Biopharmaceutical Research;2023-04-07

2. Innovations in Clinical Development in Rare Diseases of Children and Adults: Small Populations and/or Small Patients;Pediatric Drugs;2022-10-15

3. Tests and classification methods in adaptive designs with applications;Journal of Applied Statistics;2022-01-21

4. The optimal design of clinical trials with potential biomarker effects: A novel computational approach;Statistics in Medicine;2021-01-11

5. Clinical trial risk in leukemia: Biomarkers and trial design;Hematological Oncology;2020-10-28