Advertisement
Mayo Clinic Proceedings Home

Increased Utilization of Virtual Visits and Electronic Approaches in Clinical Research During the COVID-19 Pandemic and Thereafter

      Abstract

      Objectives

      To assess the impact of the COVID-19 pandemic on clinical research and the use of electronic approaches to mitigate this impact.

      Methods

      We compared the utilization of electronic consenting, remote visits, and remote monitoring by study monitors in all research studies conducted at Mayo Clinic sites (Arizona, Florida, and Minnesota) before and during the COVID-19 pandemic (ie, between May 1, 2019 and December 31, 2020). Participants are consented through a participant-tracking system linked to the electronic health record.

      Results

      Between May 2019, and December 2020, there were 130,800 new consents across every modality (electronic and paper) to participate in a non-trial (107,176 [82%]) or a clinical trial (23,624 [18%]). New consents declined from 5741 in February 2020 to 913 in April 2020 but increased to 11,864 in November 2020. The mean (standard deviation [SD]) proportion of electronic consent increased from 22 (2%) before to 45 (20%) during the pandemic (P=.001). Mean (SD) remote electronic consenting increased from 0.3 (0.5%) to 29 (21%) (P<.001). The mean (SD) number of patients with virtual visits increased from 3.5 (2.4%) to 172 (135%) (P=.003) per month between pre-COVID (July 2019 to February 2020) and post-COVID (March to December 2020) periods. Virtual visits used telemedicine (68%) or video (32%). Requests for remote monitor access to complete visits increased from 44 (17%) per month between May 2019 and February 2020 to 111 (74%) per month between March and December 2020 (P=.10).

      Conclusion

      After a sharp early decline, the enrollment of new participants and ongoing study visits recovered during the COVID-19 pandemic. This recovery was accompanied by the increased use of electronic tools.

      Abbreviations and Acronyms:

      EHR (electronic health record), HIPAA (Health Insurance Portability and Accountability Act), IRB (Mayo Clinic Institutional Review Board), PTrax (Participant Tracking System)
      To read this article in full you will need to make a payment

      Subscribe:

      Subscribe to Mayo Clinic Proceedings
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Inan O.T.
        • Tenaerts P.
        • Prindiville S.A.
        • et al.
        Digitizing clinical trials.
        Npj Digit Med. 2020; 3: 101
        • Unger J.M.
        • Vaidya R.
        • Hershman D.L.
        • Minasian L.M.
        • Fleury M.E.
        Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation.
        J Natl Cancer Inst. 2019; 111: 245-255
        • Tolaney S.M.
        • Lydon C.A.
        • Li T.
        • et al.
        The impact of COVID-19 on clinical trial execution at the Dana-Farber Cancer Institute.
        J Natl Cancer Inst. 2020; (Online ahead of print)https://doi.org/10.1093/jnci/dja144
        • Meagher K.M.
        • Cummins N.W.
        • Bharucha A.E.
        • Badley A.D.
        • Chlan L.L.
        • Wright R.S.
        COVID-19 ethics and research.
        Mayo Clin Proc. 2020; 95: 1119-1123
        • Rubio-San-Simón A.
        • Andre N.
        • Cefalo M.G.
        • et al.
        Impact of COVID-19 in paediatric early-phase cancer clinical trials in Europe: a report from the Innovative Therapies for Children with Cancer (ITCC) consortium.
        Eur J Cancer. 2020; 141: 82-91
        • McDermott M.M.
        • Newman A.B.
        Remote research and clinical trial integrity during and after the coronavirus pandemic.
        JAMA. 2021; 325: 1935-1936
        • Doroshow J.H.
        COVID-19 and cancer clinical trials.
        Natl Cancer Inst. 2020; (Online ahead of print)https://doi.org/10.1093/jnci/djaa162
      1. Guidance Document. FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic: guidance for industry, investigators, and institutional review boards. Rockville, MD: Food and Drug Administration; FDA-2020-D1106-0002.

        • NIH Staff
        Guidance for NIH-funded clinical trials and human subjects studies affected by COVID-19.
        National Institutes of Health, Bethesda, MD2020
        • 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: memorandum.
        National Institutes of Health, Bethesda, MD2020
        • Watters J.T.
        • Pitzen J.H.
        • Sanders L.J.
        • et al.
        Transforming the activation of clinical trials.
        Clin Pharmacol Ther. 2018; 103: 43-46
        • Doroshow J.H.
        • Prindiville S.
        • McCaskill-Stevens W.
        • Mooney M.
        • Loehrer P.J.
        COVID-19, social justice, and clinical cancer research.
        J Natl Cancer Inst. 2020; (Online ahead of print)https://doi.org/10.1093/jnci/djaa162
        • Lackland D.T.
        • Sims-Robinson C.
        Jones Buie JN, Voeks JH. Impact of COVID-19 on clinical research and inclusion of diverse populations.
        Ethn Dis. 2020; 30: 429-432
        • Srinivasan M.
        • Asch S.
        • Vilendrer S.
        • et al.
        Qualitative assessment of rapid system transformation to primary care video visits at an academic medical center.
        Ann Intern Med. 2020; 173: 527-535
      2. Bharucha AE, Wi CI, Srinivasan SG, et al. Participation of rural patients in clinical trials at a multisite academic medical center [published online July 12, 2021]. J Clin Transl Sci. http://doi.org/10.1017/cts.2021.813.

        • Borno H.T.
        • Zhang L.
        • Siegel A.
        • Chang E.
        • Ryan C.J.
        At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical crials.
        Oncologist. 2018; 23: 1242-1249
        • Nipp R.D.
        • Lee H.
        • Powell E.
        • et al.
        Financial burden of cancer clinical trial participation and the impact of a cancer care equity program.
        Oncologist. 2016; 21: 467-474
        • Nipp R.D.
        • Lee H.
        • Gorton E.
        • et al.
        Addressing the financial burden of cancer clinical trial participation: longitudinal effects of an equity intervention.
        Oncologist. 2019; 24: 1048-1055
        • Branch E.
        Ways to lower costs of clinical trials and how CROs help.
        Am Pharm Rev. April 30, 2016;