Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality

Author:

Unger Joseph M.1ORCID,Stires Hillary2ORCID,Levit Laura A.3ORCID,Stewart Mark2ORCID,McKelvey Brittany Avin2ORCID,Canin Beverly4ORCID,Dressler Emily5,Flaherty Keith6ORCID,Fredette Peter7,Jones Lee8ORCID,McCann Peggy9,Miller Therica10ORCID,Onitilo Adedayo A.11ORCID,Palmieri Fran12,Patel Timil13,Paul Rocio14,Smith Gary L.14,Bruinooge Suanna S.3ORCID,Garrett-Mayer Elizabeth3ORCID,Lei Xiudong Jennifer15,Alva Ajjai16,Schenkel Caroline3ORCID

Affiliation:

1. Fred Hutchinson Cancer Center, Seattle, WA

2. Friends of Cancer Research, Washington, DC

3. American Society of Clinical Oncology (ASCO), Alexandria, VA

4. Breast Cancer Options, Kingston, NY

5. Wake Forest School of Medicine, Winston-Salem, NC

6. Massachusetts General Hospital, Boston, MA

7. EQRx (employed by IQVIA during study design phase), Cambridge, MA

8. Fight Colorectal Cancer, Arlington, VA

9. Merck, Rahway, NJ

10. Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY

11. Marshfield Clinic Health System, Weston, WI

12. Sarah Cannon Research Institute, Nashville, TN

13. U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD

14. National Cancer Institute, Cancer Therapy Evaluation Program, Clinical Trials Monitoring Branch, Bethesda, MD

15. University of Texas MD Anderson Cancer Center (employed by ASCO during study design phase), Houston, TX

16. University of Michigan Medical Center, Ann Arbor, MI

Abstract

ASCO-Friends study: sponsors say COVID-19–era trial flexibilities had minimal impact on treatment trial data integrity.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Oncology (nursing),Health Policy,Oncology

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