Adaptive group‐sequential design with population enrichment in phase 3 randomized controlled trials with two binary co‐primary endpoints-Reference-Cited by-同舟云学术

Adaptive group‐sequential design with population enrichment in phase 3 randomized controlled trials with two binary co‐primary endpoints

Published:2019-06-11 Issue:21 Volume:38 Page:3985-3996
ISSN:0277-6715
Container-title:Statistics in Medicine
language:en
Short-container-title:Statistics in Medicine

Author:

Sinha Arup K.¹^ORCID,Moye Lemuel²,Piller Linda B.³,Yamal Jose‐Miguel²,Barcenas Carlos H.⁴,Lin Jianchang⁵^ORCID,Davis Barry R.²

Affiliation:

1. Department of Biostatistics, School of Public HealthYale University New Haven Connecticut

2. Department of Biostatistics, School of Public HealthThe University of Texas Health Science Center at Houston Houston Texas

3. Department of Epidemiology, Human Genetics, and Environmental Sciences, School of Public HealthThe University of Texas Health Science Center at Houston Houston Texas

4. Department of Breast Medical Oncology, Division of Cancer MedicineThe University of Texas MD Anderson Cancer Center Houston Texas

5. Takeda Pharmaceuticals Cambridge Massachusetts

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/sim.8216

Reference40 articles.

1. European Medicines Agency.Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy. Draft. 2013.https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-duchenne-becker-muscular_en.pdf. Accessed April 25 2019.

2. US Department of Health and Human Services Food and Drug Administration.Migraine: developing drugs for acute treatment ‐ guidance for industry. Draft guidance. 2018.https://www.fda.gov/downloads/drugs/guidances/ucm419465.pdf. Accessed April 25 2019.

3. US Department of Health and Human Services Food and Drug Administration.Multiple endpoints in clinical trials guidance for industry. Draft guidance. 2017.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536750.pdf. Accessed April 25 2019.

4. European Medicines Agency.Guideline on multiplicity issues in clinical trials. Draft. 2017.https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-multiplicity-issues-clinical-trials_en.pdf. Accessed April 25 2019.

5. Sample size determination in group-sequential clinical trials with two co-primary endpoints

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