10 Dec COVID-19 Impacts Breast Cancer Study Data Acquisition
MedicalResearch.com Interview with:
Joanne L. Blum, MD, PhD, FACP
Texas Oncology and Director
Hereditary Cancer Risk Program
Baylor University Medical Center
MedicalResearch.com: What is the background for this study?Would you briefly describe the POLARIS study?
Response: POLARIS is an ongoing prospective, real-world, non-interventional study in patients with HR+/HER2-ABC receiving palboiclib plus endocrine therapy with a targeted enrollment of 1500 patients at 110 sites in the United States and Canada.
MedicalResearch.com: What are the main findings?
- Because of the COVID-19 pandemic, approximately one third of the study sites experienced an impact on their responsiveness to correspondence, timely data entry, and subject management.
- The geographic location or type (e.g., academic or community) of study site appears associated with whether the site was impacted by COVID-19.
- Other study site characteristics were generally similar between sites that reported an impact of COVID-19 and those that were not impacted.
- Because of inherent limitations of survey studies, these findings must be interpreted with caution.
MedicalResearch.com: What should readers take away from your report?
Response: The COVID19 pandemic had an impact on the POLARIS study data acquisition based on 2 rounds of questionnaires: March 26,-27, 2020 and April 30-May 20, 2020.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We look forward to resolution of the COVID-19 pandemic with the future widespread availability of COVID-19 vaccines so that clinical research will be unaffected in the future. However knowledge obtained by this study will inform strategies to prevent similar disruptions to clinical research in the future should the need arise.
Disclosures: I am on the steering committee for the POLARIS trial and have received support from Pfizer for that role.
Debu Tripathy 1, Joanne L Blum2, Gabrielle Rocque 3, J. Daniel Cuevas 4, Jennifer Specht5, Steven Corso 6, Jawad E Francis 7, Stephanie Mendez 8, Veneta Pope 9, Joseph Cappelleri9 and Yao Wang 9. 1The University of Texas MD Anderson Cancer Center, Houston, TX;2Texas Oncology Sammons Cancer Center, US Oncology, Dallas, TX;3University of Alabama at Birmingham, Birmingham, AL;4St. Louis Cancer Care, St. Louis, MO;5University of Washington, Seattle, WA;6Gibbs Cancer Center, Spartanburg, SC;7Mercy Health Youngstown, Youngstown, OH;8ICON plc, North Wales, PA;9Pfizer Inc, New York, NY
SABCS: Impact of COVID-19 on study sites: Survey analysis from the noninterventional POLARIS study
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