Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators-Reference-Cited by-同舟云学术

Evaluation of Treatment Effect in Underrepresented Population in Cancer Trials: Discussion with International Regulators

Published:2022-10-31 Issue: Volume: Page:1-7
ISSN:1946-6315
Container-title:Statistics in Biopharmaceutical Research
language:en
Short-container-title:Statistics in Biopharmaceutical Research

Author:

Sridhara Rajeshwari¹,Marchenko Olga²,Jiang Qi³,Barksdale Elizabeth⁴,Chen Jie⁵,Dreyer Nancy⁶,Fashoyin-Aje Lola¹,Garrett-Mayer Elizabeth⁷,Gormley Nicole¹,Gwise Thomas⁸,Hess Lorenzo⁹,Mandrekar Sumithra¹⁰,Pignatti Francesco¹¹,Rantell Khadija¹²,Raven Andrew¹³,Shen Yuan-Li⁸,Singh Harpreet¹,Tendler Craig L.¹⁴,Theoret Marc¹,Pazdur Richard¹

Affiliation:

1. Oncology Center of Excellence, US FDA, Silver Spring, MD

2. Bayer, Whippany, NJ

3. Seagen, Bothell, WA

4. LUNGevity Foundation, Chicago, IL

5. Overland Pharma, Dover, DE

6. IQVIA, Real World Solutions, Cambridge, MA

7. ASCO, Alexandria, VA

8. Office of Biostatistics, CDER US FDA, Silver Spring, MD

9. SMC, Zurich, Switzerland

10. Mayo Clinic, Rochester, MN

11. EMA, Amsterdam, Netherlands

12. MHRA, London, UK

13. HC, Ottawa, Ontario, Canada

14. Janssen, Raritan, NJ

Publisher

Informa UK Limited

Subject

Pharmaceutical Science,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/19466315.2022.2128404

Reference28 articles.

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4. FDA Guidance (2020a), “Enhancing the Diversity of Clinical Trial Populations Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry,” Available at https://www.fda.gov/media/127712/download.

5. FDA Guidance (2020b), “Inclusion of Older Adults in Cancer Clinical Trials: Guidance for Industry,” Available at https://www.fda.gov/media/135804/download.