Clinical Trials in the Age of Pandemics

Authors:
Martin J. Edelman
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Crystal S. Denlinger
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Eric A. Ross
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Margaret von Mehren
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Disclosures: Dr. Edelman has disclosed that he has served on the data safety and monitoring board for Astra-Zeneca, GlaxoSmithKline, and Takeda); has served on scientific advisory boards for Windmil, and Biomarker Strategies; has received research support from Windmil, GlaxoSmithKline, Merck, Nektar, Revolutions Medicine, and Apexigen. Dr. Denlinger has disclosed that she has served as a scientific advisor for Exelixis, Astellas, Bayer, Bristol Myer Squibb, and Taiho; and has received insitutional research support from Bristol Myer Squibb, Merrimack, Astra Zeneca, Eli Lilly, Roche, Amgen, Sanofi Aventis, BeiGene, Lycera, Macrogenics, Agios Pharmaceuticals, and Zymeworks. Dr. Ross has disclosed that he has a patent pending on screening for chemotherapy responsiveness and owns stock from Protor & Gamble. Dr. von Mehren has disclosed that she has served on scientific advisory boards for Deciphera, Blueprint, and Exelis; has received institutional research support from Deciphera, Blueprint, Arog Pharmaceuticals, Gardalis, Springworks, Novartis, and ASCO; and has received honorarium from Pfizer and ASCO.

Correspondence: Martin J. Edelman, MD, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 191111. Email: Martin.Edelman@fccc.edu
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  • 1.

    Vose JM, Levit LA, Hurley P, et al.. Addressing administrative and regulatory burden in cancer clinical trials: summary of a stakeholder survey and workshop hosted by the American Society of Clinical Oncology and the Association of American Cancer Institutes. J Clin Oncol 2016;34:37963802.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 2.

    Kim ES, Bruinooge SS, Roberts S, et al.. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. J Clin Oncol 2017;35:37373744.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 3.

    Guan WJ, Ni ZY, Hu Y, et al.. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020;382:17081720.

  • 4.

    Fauci AS, Lane HC, Redfield RR. Covid-19 - navigating the uncharted. N Engl J Med 2020;382:12681269.

  • 5.

    Liang W, Guan W, Chen R, et al.. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol 2020;21:335337.

  • 6.

    Ong MBH. Doroshow: NCI to accrue patients for COVID-19 longitudinal cohort: ongoing trials see significant decrease in accrual. The Cancer Letter. Accessed March 23, 2020. Available at: https://cancerletter.com/articles/20200417_2/

    • Search Google Scholar
    • Export Citation
  • 7.

    Code of Federal Regulation §46.108 (a)(3)(iii) and 21 CFR 56.108(a)(4).

  • 8.

    Mooney M, McCaskill-Stevens W. Interim guidance for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP). Accessed March 23, 2020. Available at: https://ctep.cancer.gov/content/docs/Memorandum_on_Interim_Guidance_for_Clinical_Trial_Activities_Affected_by_the_Novel_Coronavirus-3-13-2020.pdf

  • 9.

    FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic. Accessed July 10, 2020. Available at: https://www.fda.gov/media/136238/download

  • 10

    Mooney M, McCaskill-Stevens W. Additional guidance regarding alternative procedures for clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and NCI Community Oncology Research Program (NCORP) affected by the spread of the novel coronavirus. Accessed March 23, 2020. Available at: https://ncorp.cancer.gov/d/Memorandum-on-Additional-Guidance-for-Clinical-Trial-Activities-Affected-by-the-Novel-Coronavirus_3-23-2020.pdf

  • 11.

    Hollander JE, Carr BG. Virtually perfect? Telemedicine for Covid-19. N Engl J Med 2020;382:16791681.

  • 12.

    Tarantino P, Trapani D, Curigliano G. Conducting phase 1 cancer clinical trials during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease pandemic. Eur J Cancer 2020;132:810.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
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