The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

doi:10.1007/s12609-021-00417-z

Review

. 2021;13(3):103-109.

doi: 10.1007/s12609-021-00417-z. Epub 2021 May 12.

The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

Amara Ndumele¹, Ko Un Park²

Affiliations

¹ College of Medicine, The Ohio State University, Columbus, OH USA.
² Division of Surgical Oncology, Department of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH USA.

PMID: 33995839
PMCID: PMC8112880
DOI: 10.1007/s12609-021-00417-z

Review

The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

Amara Ndumele et al. Curr Breast Cancer Rep. 2021.

. 2021;13(3):103-109.

doi: 10.1007/s12609-021-00417-z. Epub 2021 May 12.

Authors

Amara Ndumele¹, Ko Un Park²

Affiliations

¹ College of Medicine, The Ohio State University, Columbus, OH USA.
² Division of Surgical Oncology, Department of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH USA.

PMID: 33995839
PMCID: PMC8112880
DOI: 10.1007/s12609-021-00417-z

Abstract

Purpose of review: The COVID-19 pandemic has had a devastating impact on virtually all aspects of the healthcare system, including oncology clinical trials. The purpose of this review is to describe the impact of the pandemic on national breast cancer clinical trials.

Recent findings: Of the 61 breast cancer-specific cooperative group breast cancer clinical trials open to accrual during the pandemic, 32% of them received supplementary tailored guidance regarding current and foreseeable challenges for clinical sites and investigators due to COVID-19. Many clinical trial sites reported decreases in enrollment and accrual, drastic disruptions to protocol, and challenges related to research infrastructure, staff burden, and assuring social distancing.

Summary: The challenges early in pandemic led to many operational changes in clinical trials, including use of electronic consent for enrollment, telemedicine visits, and mail order pharmacy. The pandemic highlighted aspects of breast cancer clinical trial that could be modernized while maintaining research integrity.

Keywords: Breast cancer; COVID-19; Clinical trial; Telemedicine.

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Conflict of interest statement

Conflict of InterestThe authors declare no competing interests.

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References

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[1] WHO. WHO Coronavirus Disease (COVID-19) Dashboard. World Health Organization. 2020. https://covid19.who.int/. Accessed 2 Jan 2021.

[2] WHO. WHO Coronavirus Disease (COVID-19) Dashboard. World Health Organization. 2020. https://covid19.who.int/. Accessed 2 Jan 2021.

[3] Blumenthal D, Fowler EJ, Abrams M, et al. Covid-19—implications for the Health Care System. N Engl J Med. 2020;383(15):1483–8. - PubMed

[4] Blumenthal D, Fowler EJ, Abrams M, et al. Covid-19—implications for the Health Care System. N Engl J Med. 2020;383(15):1483–8. - PubMed

[5] van Dorn A. COVID-19 and readjusting clinical trials. Lancet. 2020;396(10250):523–524. doi: 10.1016/S0140-6736(20)31787-6. - DOI - PMC - PubMed

[6] van Dorn A. COVID-19 and readjusting clinical trials. Lancet. 2020;396(10250):523–524. doi: 10.1016/S0140-6736(20)31787-6. - DOI - PMC - PubMed

[7] North CM, Dougan ML, Sacks CA. Improving clinical trial enrollment—in the Covid-19 era and beyond. N Engl J Med. 2020;383(15):1406–8. - PubMed

[8] North CM, Dougan ML, Sacks CA. Improving clinical trial enrollment—in the Covid-19 era and beyond. N Engl J Med. 2020;383(15):1406–8. - PubMed

[9] Miller KD, Nogueira L, Mariotto AB, et al. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019;69(5):363–385. doi: 10.3322/caac.21565. - DOI - PubMed

[10] Miller KD, Nogueira L, Mariotto AB, et al. Cancer treatment and survivorship statistics, 2019. CA Cancer J Clin. 2019;69(5):363–385. doi: 10.3322/caac.21565. - DOI - PubMed

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The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

Affiliations

The Impact of COVID-19 on National Clinical Trials Network Breast Cancer Trials

Authors

Affiliations

Abstract

Conflict of interest statement

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