{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T00:59:10Z","timestamp":1793235550143,"version":"4.5.0"},"reference-count":37,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO Oncology Advances"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>The onset of the COVID-19 pandemic in early 2020 disrupted the conduct of cancer clinical trials. In response, federal agencies allowed more flexibility for trial recruitment and patient follow-up. A key question is whether the benefits of adopting these strategies outweigh the potential detriments to quality metrics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>A joint ASCO and Friends of Cancer Research task force invited industry and National Cancer Institute trial sponsors to contribute deidentified trial-level aggregate data on enrollment, major protocol deviations, dropouts, and severe adverse events (Common Terminology Criteria for Adverse Events grade 3-5). These quality metrics were examined as proportions of participants at risk during the pre\u2013COVID-19 (January 2017-February, 2020), initial wave (March-April, 2020), initial recovery (May-December, 2020), and secondary recovery (January 2021-December 2022) periods. Multilevel beta-regression was used, adjusting for phase; study and sponsor were treated as random effects. Indicator variables were used with pre\u2013COVID-19 as the reference.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Ten sponsors contributed 67 analyzable trials with N = 12,000 US-based participants. Enrollment odds decreased 49% in the initial wave (odds ratio [OR], 0.51 [95% CI, 0.30 to 0.86],\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .01) but recovered to pre\u2013COVID-19 levels by 2021-2022 (OR, 1.01 [95% CI, 0.56 to 1.81],\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .97). Major protocol deviations, dropouts, and severe toxicity all had a lower incidence in the initial wave compared with pre\u2013COVID-19; these outcomes were also less frequent (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .05) in the initial recovery period but returned to pre\u2013COVID-19 levels by 2021-2022.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>In this multicollaborator evaluation, large declines in enrollment, major protocol deviations, dropouts, and severe toxicity during the acute phase of the pandemic all returned to pre\u2013COVID-19 levels by 2021-2022. These findings highlight the impact of the temporary disruption to trial conduct during the pandemic's peak, but suggest that pandemic-related procedural flexibility did not result in long-term reduced data quality. Sponsors and regulators should consider broader adaptation of trial flexibilities moving forward.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/oa-25-00021","type":"journal-article","created":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T15:59:08Z","timestamp":1749830348000},"source":"Crossref","is-referenced-by-count":7,"title":["Impact of the COVID-19 Pandemic Mitigation Strategies on Cancer Treatment Trials: A Meta-Analysis of Industry and National Cancer Institute Studies"],"prefix":"10.1200","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5191-0317","authenticated-orcid":true,"given":"Joseph M.","family":"Unger","sequence":"first","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0177-2024","authenticated-orcid":true,"given":"Hillary S.","family":"Andrews","sequence":"additional","affiliation":[{"name":"Friends of Cancer Research, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9136-4229","authenticated-orcid":true,"given":"Laura A.","family":"Levit","sequence":"additional","affiliation":[{"name":"American Society of Clinical Oncology, Alexandria VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9239-7153","authenticated-orcid":true,"given":"Brittany A.","family":"McKelvey","sequence":"additional","affiliation":[{"name":"Friends of Cancer Research, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4847-0736","authenticated-orcid":true,"given":"Mark","family":"Stewart","sequence":"additional","affiliation":[{"name":"Friends of Cancer Research, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7864-1121","authenticated-orcid":true,"given":"Beverly","family":"Canin","sequence":"additional","affiliation":[{"name":"Breast Cancer Options, Kingston, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3402-0478","authenticated-orcid":true,"given":"Keith","family":"Flaherty","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7174-9330","authenticated-orcid":true,"given":"Denise","family":"Kimball","sequence":"additional","affiliation":[{"name":"Johnson &amp; Johnson, New Brunswick, NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4086-3076","authenticated-orcid":true,"given":"Therica","family":"Miller","sequence":"additional","affiliation":[{"name":"Tisch Cancer Center, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9185-0606","authenticated-orcid":true,"given":"Adedayo","family":"Onitilo","sequence":"additional","affiliation":[{"name":"Marshfield Clinic Health System, Weston, WI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9936-2719","authenticated-orcid":true,"given":"Suanna","family":"Bruinooge","sequence":"additional","affiliation":[{"name":"American Society of Clinical Oncology, Alexandria VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4709-0333","authenticated-orcid":true,"given":"Elizabeth","family":"Garrett-Mayer","sequence":"additional","affiliation":[{"name":"American Society of Clinical Oncology, Alexandria VA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3613-8509","authenticated-orcid":true,"given":"Caroline","family":"Schenkel","sequence":"additional","affiliation":[{"name":"Children's National Hospital, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.10651"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05219-3"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.04.071"},{"key":"e_1_3_6_5_2","unstructured":"National Cancer Institute: Coronavirus guidance 2022. https:\/\/ctep.cancer.gov\/investigatorResources\/corona_virus_guidance.htm"},{"key":"e_1_3_6_6_2","unstructured":"US Food and Drug Administration: FDA guidance on conduct of clinical trials of medical products during COVID-19 pandemic 2020. https:\/\/www.fda.gov\/regulatory-information\/search-fdaguidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic"},{"key":"e_1_3_6_7_2","doi-asserted-by":"publisher","DOI":"10.1200\/OP.23.00185"},{"key":"e_1_3_6_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2021.18433"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1441"},{"key":"e_1_3_6_10_2","doi-asserted-by":"crossref","first-page":"120","DOI":"10.1016\/j.conctc.2018.06.008","article-title":"Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain","volume":"11","author":"Sommer C","year":"2018","unstructured":"Sommer C, Zuccolin D, Arnera V, et al: Building clinical trials around patients: Evaluation and comparison of decentralized and conventional site models in patients with low back pain. 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