The Impact of COVID-19 on Cancer Clinical Trials Conducted by NCI-Designated Comprehensive Cancer Centers

The impact of the coronavirus disease 2019 (COVID-19) pandemic on cancer clinical trials has led many National Cancer Institute (NCI)-designated cancer centers to curtail nonessential trials and reimagine the way cancer care is delivered. A study by Unger et al.[1] found that the pandemic in its earliest stages was correlated with decreased enrollment in NCI-sponsored cancer clinical trials, particularly in areas most affected by COVID-19. Likewise, a survey of clinical programs (n = 32) conducted by the American Society of Clinical Oncology (ASCO) in late March revealed that roughly 60% of respondents' programs paused screening and/or enrollment for certain clinical trials and stopped research-only visits except those providing cancer treatment.[2] While these reports provide some insight into the effect size of COVID-19 and decreased cancer clinical trial activity, no study has yet collated information on the influence COVID-19 has had on individual NCI-supported cancer centers.

As a result, we searched all NCI-designated comprehensive cancer centers' websites for information on their response to COVID-19. We then performed Google searches using keywords of the center's name, “COVID-19,” and “cancer clinical trials” to examine each center's statement on COVID-19, the impact of COVID-19 on its trials, and the adaptations made as of July 15, 2020. Among 51 total comprehensive cancer centers, 28 (54.9%) had information on some or all of these topics through either their websites or external platforms such as SWOG Cancer Research Network, OncologyLive (OncLive), and Medscape (Table 1).

Table 1.

The impact of coronavirus disease 2019 (COVID-19) on clinical trial activities among 28 comprehensive cancer centers

Institutions	Issued Statement	Impact	Proposed Solutions	Accessible Source Links
Alabama
O'Neal Comprehensive Cancer Center	During this period, we are closely monitoring our clinical trials to make sure that patients on trials receive uninterrupted treatment and to keep as many potentially lifesaving trials open as we can do safely.	N/A	N/A	https://www.uab.edu/news/health/item/11418-o-neal-cancer-center-at-uab-urges-continued-cancer-screenings-during-pandemic https://www.uab.edu/onealcancercenter/patient-care/coronavirus-info
Arizona
Arizona Cancer Center	Essential cancer research is ongoing with clinical trials continuing to accrue patients, especially those offering new treatments unavailable anywhere else in Arizona.	Most observational, noninterventional treatment studies are on hold. (July 6, 2020)	Telemedicine Rotating staff model every 14 days	https://cancercenter.arizona.edu/news/2020/05/new-safeguards-and-procedures-allow-cancer-care-research-continue-during-covid-19 https://www.healio.com/news/hematology-oncology/resources/oncology-overdrive/episode-7
California
City of Hope Comprehensive Cancer Center	[We] continue to enroll in clinical trials.	N/A	Telemedicine	https://www.cityofhope.org/patients/for-patients-and-visitors/covid-19-virus-information
Stanford Cancer Institute	We have implemented several positive measures to ensure our cancer clinical trial participants continue to receive their care safely during these difficult times. Our hope is that these new adaptations will continue to provide more equitable access to trials for all patients.	N/A	Telemedicine Remote consenting of new and ongoing participants Directly shipping orally administered study drugs to patients, whenever possible	http://med.stanford.edu/cancer/trials.html
UC Davis Comprehensive Cancer Center	For our patients participating in our clinical trials, this work continues.	N/A	N/A	https://health.ucdavis.edu/cancer/?utm_campaign=UCDH_2020_Oncology_Rebuild_BMM&utm_medium=Paid_Search&utm_source=Varick&utm_content= Oncology&utm_term=cancer_center
Moores Comprehensive Cancer Center	All therapeutic cancer clinical trials at UC San Diego Health are open for new patients and for continuation of treatment for patients currently on a study. We also continue to open new clinical trials to ensure that our patients can participate in the latest research.	N/A	Telemedicine Mailed/curbside prescriptions	https://health.ucsd.edu/coronavirus/Pages/Cancer.aspx
Colorado
University of Colorado Cancer Center	We are doing our best to make sure our patients have access to trials.	N/A	Telemedicine	https://medschool.cuanschutz.edu/colorado-cancer-center/CUCancerCenter/covid-19-information
Connecticut
Yale Cancer Center	Cancer care and treatment has been constant throughout the pandemic.	Most trial accrual has stopped; however, patients can be enrolled in exceptional cases on trials with an oral therapy for a molecular target. (March 27, 2020)	Telemedicine Expanded hours to increase social distancing	https://www.yalecancercenter.org/covid/covidfaq/ https://www.swog.org/news-events/news/2020/03/27/covid-19-slows-research-trials-continue
Florida
Moffitt Cancer Center	Despite the pandemic, more than 200 trials are currently open, treating a variety of cancer types.	Only 15 treatment clinical trials have been suspended at Moffitt due to the pandemic. The cancer center has accrued more patients to clinical trials in March than February. (April 21, 2020)	Telemedicine	https://moffitt.org/your-covid-19-information-hub/ https://moffitt.org/endeavor/archive/clinical-trials-and-covid19/
Sylvester Comprehensive Cancer Center	Clinical Treatment Unit (CTU) [will involve] closely monitored care for clinical trial patients.	N/A	Telemedicine	https://umiamihealth.org/sylvester-comprehensive-cancer-center/alerts/coronavirus-covid-19
Georgia
Winship Cancer Institute	Clinical trial continuation is patient dependent.	N/A	Telemedicine	https://winshipcancer.emory.edu/covid-19/covid19-and-cancer-patients-on-clinical-trials.html https://www.oncologynurseadvisor.com/home/cancer-types/general-oncology/ethical-challenges-and-considerations-for-clinical-trials-during-covid-19-pandemic/
Iowa
Holden Comprehensive Cancer Center	[We] decided that [we were] going to keep as many new trials [as] were necessary open.	Nearly all (95%) of the therapeutic clinical trials offered by the Holden Comprehensive Cancer Center (HCCC) at the University of Iowa are still up and running. (June 24, 2020)	Telemedicine Declared biospecimen research to be nonessential	https://www.medscape.com/viewarticle/932862
Maryland
Sidney Kimmel Comprehensive Cancer Center	Clinical trials at SKCC remain robust and comprehensive, as of April 27. We have dedicated staff to ensure clinical trials are still effectively and safely ongoing here at the center.	N/A	Telemedicine Additional early-morning and evening appointments for the infusion center and radiation oncology	https://sidneykimmelcancercenter.jeffersonhealth.org/?article=2020-cancer-and-covid-19–coronavirus-
Massachusetts
Dana-Farber/Harvard Cancer Center	Dana-Farber clinical investigators and their teams have kept clinical trials on track and in compliance with the elaborate rules that govern them.	Of the thousands of patients currently enrolled in clinical trials at the institute, fewer than 10 have needed to drop out for logistical or transportation-related reasons since the coronavirus outbreak hit Boston in early March. (May 14, 2020)	Telemedicine Oral medications sent to patients' homes Labs/CTs can be performed offsite Biopsies are not being performed for clinical trials Correlative research restrictions	https://blog.dana-farber.org/insight/2020/05/dana-farber-clinical-research-stays-on-track-during-covid-19/
Michigan
The Barbara Ann Karmanos Cancer Institute	As of 6/1/2020, Karmanos Cancer Institute resumes all services as cases of COVID-19 decline and Michigan governor lifts restrictions.	Throughout the COVID-19 pandemic, the volume of patients seen by Karmanos Cancer Institute decreased significantly. While this is largely due to the restrictions put into place by the state of Michigan, some patients may have opted to delay care out of concern or anxiety. (June 1, 2020)	Telemedicine	https://www.karmanos.org/karmanos/news/karmanos-cancer-institute-resumes-all-services-as-2868
Minnesota
Mayo Clinic Cancer Center	The cancer center has resumed a more normalized state of study operation and began to open “most” of its clinical trials the week of May 11.	Mayo Clinic halted translational data collection and primarily provided phase 2 and phase 3 trial offerings and “very limited” phase 1 studies. In lieu of suspending studies, Mayo Clinic asked clinicians to internally consult with the clinical research chairs on a new patient enrollment to a given trial and obtain approval from the research chair. Unsurprisingly, Mayo Clinic saw a dip in patient accruals: “[at] the lowest point, our enrollment dropped to probably a third of our normal enrollment.” (June 19, 2020)	Telemedicine	https://www.onclive.com/view/oncology-centers-examine-the-aftermath-of-covid-19-on-clinical-trials
New York
Memorial Sloan Kettering Cancer Center	As we come out of the acute COVID-19 crisis (June 1, 2020), we are committed to fully supporting clinical trial enrollment along with the expansion of standard care as patient volumes return to more normal levels over the next few months.	Over March and April, therapeutic trial accrual was reduced by 75%.	Telemedicine COVID-19 test required for patients who have traveled to areas with significant community spread	https://www.cancertodaymag.org/Pages/cancer-talk/Trials-Interrupted.aspx https://www.mskcc.org/videos/what-msk-doing-protect-me-process-screening-patients-and-families
Roswell Park Comprehensive Cancer Center	[We continue] face-to-face appointments for patients in clinical trials, with the exception of virtual visits for some patients in clinical trials using oral medications and/or on long-term follow-up.	N/A	Telemedicine	https://www.roswellpark.org/coronavirus/faqs
Herbert Irving Comprehensive Cancer Center	[We will] continue providing exceptional cancer care.	As of March 27, 2020, the center has shut down all trial enrollment. No updates were seen on their website since mid-July.	Telemedicine COVID-19 testing before treatment	https://www.swog.org/news-events/news/2020/03/27/covid-19-slows-research-trials-continue https://cancer.columbia.edu
North Carolina
UNC Lineberger Comprehensive Cancer Center	[We will] continue to provide outstanding cancer care and clinical trials.	N/A	Telemedicine	https://unclineberger.org/news/coronavirus-updates/
Ohio
Case Comprehensive Cancer Center	We chose to keep treatment trials open for our patients, many of whom have few other therapeutic options, and because we were confident that we could do so safely even amidst the pandemic.	[We] saw a rise in enrollment to treatment studies of 11% by the end of June, compared to the same period last year. This occurred despite approximately 8%–10% of treatment trials being suspended due to COVID-19 by the sponsors. (July 10, 2020)	Virtual adaptations (not specified)	https://case.edu/cancer/cancer/cancer/cancer/index.php/about-us/news/associate-directors-message-update-clinical-trial-activity-during-covid-19
The Ohio State University Comprehensive Cancer Center	[We are] continuing treatment during the pandemic per oncologist recommendations.	Only trials with a critical therapeutic outcome, extremely modest staffing needs, or time-sensitive enrollment targets continued. (June 16, 2020)	Telemedicine	https://www.statnews.com/2020/06/16/cancer-patients-doctors-carry-on-clinical-trials-during-covid-19/
Oregon
Knight Cancer Institute	Most studies that provide important new therapies remain open for participation. For patients currently participating in clinical trials, we will continue to provide treatment as planned.	N/A	Telemedicine	https://www.ohsu.edu/sites/default/files/2020-03/A%20message%20about%20clinical%20trials%20at%20the%20OHSU%20Knight%20Cancer%20Institute_1.pdf
Pennsylvania
UPMC Hillman Cancer Center	We see clinical trials as part of cancer treatment, so we've tried to keep as many open as possible.	[We have] preemptively paused patient enrollment in nontherapeutic clinical studies of pain management and palliative care interventions.	Telemedicine	https://www.onclive.com/view/oncology-centers-examine-the-aftermath-of-covid-19-on-clinical-trials
		We suspended or reduced activity for around 80 trials over a 1- to 2-week period, and then we were able to reopen them with the help of our institutional review board. These impediments were further compounded by reduced clinic schedules and social distancing guidelines unique to the COVID-19 health crisis, culminating in a 20% to 30% decrease in accruals. (June 19, 2020)
Tennessee
Vanderbilt-Ingram Cancer Center	The pandemic has not halted Vanderbilt-Ingram's robust cancer research programs.	N/A	Telemedicine Shipment of oral medications to patients' homes	https://t.e2ma.net/message/vdlxbc/f92r20
Texas
The University of Texas MD Anderson Cancer Center	MD Anderson is modifying clinical research.	Trials that cannot use remote methods of interaction are being suspended. Exceptions are for trials with curative intent or where the trial is needed for life-prolonging or lifesaving opportunity over current standard of care options, or when there are no standard of care options. (April 2, 2020)	Telemedicine Requiring quarantine for new patients traveling from outside Texas Suspending nonessential laboratory research	https://www.mdanderson.org/newsroom/md-anderson-implements-restrictions-due-to-2019-novel-coronaviru.h00-159380367.html
Utah
Huntsman Cancer Institute	[We are] allowing enrollment to treatment trials if physicians believe it's the best way to provide patient care.	N/A	Telemedicine	https://www.swog.org/news-events/news/2020/03/27/covid-19-slows-research-trials-continue
Wisconsin
University of Wisconsin Carbone Cancer Center	Clinical cancer research is continuing in a limited fashion, focusing on our studies offering therapies not otherwise available.	Several clinical trials were shut down (unspecified). Carbone Cancer Center radiation oncologist Dr. Randy Kimple estimates patient treatment volume down 20%. (May 1, 2020)	Telemedicine	https://cancer.wisc.edu/wp-content/uploads/2020/04/HB-Update-Letter-PUBLIC-March-30.pdf https://spectrumnews1.com/wi/madison/coronavirus/2020/05/01/covid-19-concern–some-cancer-patients-avoiding-treatment-at-uw-health

N/A, not applicable; information was not available on the respective comprehensive cancer center's website(s)

All 28 centers issued broad statements in support of continuing necessary clinical trials, while maximizing patient safety through both holistic and patient-dependent protocols. Though statistics on the pandemic's effect on trial enrollment were largely absent on centers' websites, some directors of these centers commented on impediments faced by way of external platforms. For example, Robert L. Ferris, MD, PhD, director of University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, and Steven R. Alberts, MD, deputy director for Clinical Research at the Mayo Clinic Cancer Center, noted their centers' respective reductions through an OncLive article published on June 19, 2020[3]:

“UPMC suspended or reduced activity for around 80 trials over a 1- to 2-week period, and then we were able to reopen them with the help of our institutional review board. These impediments were further compounded by reduced clinic schedules and social distancing guidelines unique to the COVID-19 health crisis, culminating in a 20% to 30% decrease in accruals.”

“Mayo Clinic halted translational data collection and primarily provided phase 2 and phase 3 trial offerings, and ‘very limited' phase 1 studies. . . . At the lowest point, our enrollment dropped to probably a third of our normal enrollment.”

A handful of centers have noted less significant changes in their operations, with the Dana-Farber Cancer Institute commenting that fewer than 10 patients have needed to drop out of trials for logistical or transportation-related reasons (May 14, 2020).[4] Case Comprehensive Cancer Center has even seen a rise in enrollment to treatment studies of 11% by the end of June compared to the same period last year (July 10, 2020).[5] These varied effects potentially highlight differences in optimal standards, patient populations, and temporal analysis of data by center, which necessitate monitoring to comprehensively study the pandemic's full impact on cancer care as enrollment now rebounds.

What has been widely consistent, however, is the use of telemedicine among all 28 centers. In accordance with guidance issued by the US Food and Drug Administration[6] and the NCI,[7] all institutes have attempted to decentralize trials, in which physician visits are conducted virtually and labs and imagining are performed at outside facilities closer to patients' homes. Some sites such as the Moores Cancer Center at UCSD, Stanford Cancer Center, and Dana-Farber Cancer Institute have also directly shipped orally administered study drugs to patients whenever possible.[4,8,9] Additionally, The University of Arizona Cancer Center has implemented another safeguard of a rotating staff model, in which one team sees patients on-site for 14 days, while another team self-quarantines for 14 days and performs telehealth services.[10] These technological and structural adaptations have allowed for enhanced patient safety while keeping several trials operational.

Following the pandemic, the increased reliance on these changes may be prudent to continue, considering that less than 5% of adult cancer patients enroll in cancer clinical trials owing to barriers to trial participation.[11] Two of the biggest challenges are the travel and time costs of conventional trials and overly strict eligibility criteria that diminish trial accrual. In light of these barriers being further highlighted by the pandemic, Doherty et al.[12] have presented recommendations to modernize clinical cancer trials, including broadening eligibility criteria per ASCO recommendations,[13] documenting informed consent remotely, limiting in-person screening assessments to a single visit, implementing courier transfer of self-administered drugs, and allowing safety assessments in non-study centers. Beyond maximizing patient-centered care and minimizing infection risk, such an approach may increase participation among minority populations, an urgent need that has been further highlighted by the disproportionate impact of COVID-19 on communities of color.[14]

In conclusion, in searching NCI-supported comprehensive cancer centers' websites and associated articles on COVID-19′s enduring implications, we observed that most centers are attempting their best to continue clinical trials for participants via a decentralized approach, although it is often unclear which trials have been halted or how enrollment has changed. To best educate and address patients' concerns presently, we propose all NCI-designated cancer centers create a dedicated COVID-19 page to their websites, specifically discussing clinical trial conduct and accrual statistics. We recommend this page be updated on a monthly basis at minimum, given the fast-evolving nature of the pandemic.

Funding Statement

Sources of Support: None.