The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute
| Autor: | Mary-Ellen Taplin, Kristen A. Legor, Tianyu Li, Andrea Standring, Steven G. DuBois, Bruce E. Johnson, Sara M. Tolaney, Caryn M Caparrotta, Nabihah Tayob, Jiale Dai, Daniel I. Glazer, Jeffrey A. Meyerhardt, Christine A. Lydon, Matthew P. Schenker |
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| Rok vydání: | 2020 |
| Předmět: |
Cancer Research
Telemedicine medicine.medical_specialty Research Subjects Psychological intervention Staffing 03 medical and health sciences 0302 clinical medicine Virtual patient Neoplasms cancer Humans Medicine Medical prescription Adverse effect 030304 developmental biology clinical trials Clinical Trials as Topic 0303 health sciences SARS-CoV-2 business.industry COVID-19 United States Clinical trial Clinical research clinical research Oncology 030220 oncology & carcinogenesis Emergency medicine Commentary AcademicSubjects/MED00010 business |
| Zdroj: | JNCI Journal of the National Cancer Institute JNCI: Journal of the National Cancer Institute |
| ISSN: | 1460-2105 0027-8874 |
| Popis: | Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19–related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients. |
| Databáze: | OpenAIRE |
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