A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research-Reference-Cited by-同舟云学术

A note regarding the special issue on innovative design and analysis of complex clinical trials and opportunities for future research

Published:2021-03-04 Issue:2 Volume:31 Page:113-116
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Seifu Yodit¹,Gamalo-Siebers Margaret²,Lin Junjing³^ORCID

Affiliation:

1. Amgen, Inc., One, Thousand Oaks, California, USA

2. Pfizer, Collegeville, Pennsylvania, USA

3. Takeda Pharmaceutical Co. Limited, Cambridge, Massachusetts, USA

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2021.1895193

Reference20 articles.

1. Dose-finding design and benchmark for a right censored endpoint

2. Multiplicity issues for platform trials with a shared control arm

3. European Medicines Agency (EMA). ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. Step 5. 17 February 2020. Accessed December 20, 2020. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf.

4. Food and Drug Administration (FDA). Statistical reviews for application number 761052Orig1s000 (Brineura). 2017.Accessed December 20, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761052Orig1s000StatR.pdf.

5. Food and Drug Administration (FDA). Approval package for application number 207103Orig1s008 (IBRANCE). 2019a. Accessed December 20, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/207103Orig1s008.pdf.