Abstract SS2-10: Impact of COVID-19 on study sites: Survey analysis from the noninterventional POLARIS study
Authors: Tripathy Debu , Blum Joanne L , Rocque Gabrielle , Cuevas J. Daniel , Specht Jennifer , Corso Steven , Francis Jawad E , Mendez Stephanie , Pope Veneta , Cappelleri Joseph , Wang Yao 
Published: February 2021

Background: The COVID-19 pandemic is negatively affecting patient enrollment, therapy administration, and patient visits in breast cancer clinical trials worldwide. COVID-19 may have a lasting impact on how clinical trials are conducted, and guidelines are necessary to inform trial design and patient safety. While many groups and journals have recently published guidelines, including NCCN, ESMO, IQVIA, and Lancet Oncology, there is no consensus on how to treat patients in the current environment. Understanding and quantifying the impact of the pandemic on clinical study sites will help inform the rational development of a consensus approach. The goal of this survey was to gather site-level data on the impact of COVID-19 from clinical sites participating in the POLARIS study (NCT03280303), an ongoing, prospective, real-world, noninterventional study in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer receiving palbociclib plus endocrine therapy. Methods: Two rounds of questionnaires were sent to investigators at POLARIS study sites: 1 via email March 26-27, 2020, and 1 via telephone from April 30-May 20, 2020. The questions on COVID-19 impact and management are shown in the Table. Results: Eighty of 122 POLARIS study sites contacted responded to the March questionnaire, and 86 responded to the April-May questionnaire. In March, 33% (26/80) of the surveyed population were working predominantly remotely, 26% (21/80) were working both onsite and remotely, and 31% (25/80) were working onsite. Approximately 24% of sites reported delayed data entry. The option of telemedicine or office visits was offered to subjects at approximately 73% (58/80) of sites, and 11% (9/80) of sites were restricted to telemedicine visits. In April-May, 36% (31/86) of respondents reported an impact on study management and 64% (55/86) reported no impact. Approximately 94% (81/86) of surveyed sites felt they were able to maintain clinical studies despite the challenges due to COVID-19, and 79% (68/86) of sites had the option for telemedicine and/or office visits, while 18% (16/86) had no telemedicine alternative. In April-May, 38% of sites reported an impact on patient visits. Conclusion: Although these findings must be interpreted with caution due to the limitations of survey studies, the results suggest that approximately 1/3 of the study sites will experience an impact on their responsiveness to correspondence, timely data entry, and subject management due to the COVID-19 pandemic. Telemedicine may be used to mitigate the effect of the pandemic on clinical trial execution. Pfizer (NCT03280303)

Table. Survey QuestionsMarch Questionnaire (March 26-27, 2020)QuestionResponsesWorking onsite or remotely?26 sites are predominately working remotely21 sites are working a combination of onsite and remotely25 sites are working onsite7 sites provided inconclusive responsesSubject visits in office, by phone, by video, or a combination of 3 options?50 sites are using a combination of onsite and telemedicine8 sites have onsite visits9 sites have telemedicine visits only8 sites provided inconclusive responses4 instances where question was inapplicable due to no active subjectsIs data entry delayed?19 sites responded Yes54 sites responded No6 sites provided inconclusive responsesIs collection of biomarker blood samples impacted?11 sites indicated there will be impact to biomarker collection28 sites indicated there will be no impact to biomarker collection40 instances where question was inapplicable due to no subjects participating in collectionWhat other study areas are impacted?20 sites indicated impact due to financial challenges or limited abilities while working remotelyRemaining sites did not note any additional areas of impactPatient-reported outcome questionnaire issues?Most sites had not experienced any issues, but an overwhelming majority inquired about the ability to do them via phone or mail. Many sites and subjects expressed preference for the paper questionnaire instead of the electronic version.May Questionnaire (April 30-May 20, 2020)QuestionResponsesHas COVID-19 impacted your site’s ability to execute a study?55 sites responded No• Clarify impact on your site31 sites responded Yes• Subject visits impacted (limited onsite visits): 24• Institutional restrictions/limited staff: 7Is there any impact on scheduled onsite standard of care patient visits?53 sites responded No33 sites responded YesPlease indicate which if any of the following apply to your site:67 sites responded that telemedicine is in place for subject visitsProcess in place for remote patient study visits16 sites responded that there is no alternative for telemedicineProcess is used for remote patient study visits1 site noted that they have no active subjectsAlternative methods are available to deliver drug1 site noted that subjects are attending on site visitsOther1 site did not respond to questionHow able are you to maintain ongoing studies at this time?27 sites are extremely able to do so42 sites are very able to do soExtremely able to do so12 sites are moderately able to do soVery able to do so5 sites are able to do so only a littleModerately able to do so• COVID impact is felt more profoundly at 4 sitesA little able to do so• Financial barrier has limited one site’s time on studyNot at all able to do so0 Sites unable to do so at all

Citation Format: Debu Tripathy, Joanne L Blum, Gabrielle Rocque, J. Daniel Cuevas, Jennifer Specht, Steven Corso, Jawad E Francis, Stephanie Mendez, Veneta Pope, Joseph Cappelleri, Yao Wang. Impact of COVID-19 on study sites: Survey analysis from the noninterventional POLARIS study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr SS2-10.