{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T10:59:57Z","timestamp":1761562797715,"version":"3.40.5"},"reference-count":19,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"1","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO Oncology Practice"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec><jats:title>PURPOSE:<\/jats:title><jats:p>The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19\u2013related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19\u2013related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19\u2013related adjustments on data quality ( P = .02) and patient experience ( P = .002) improved significantly. However, perceived effect on patient safety ( P = .02) and respondent's experience ( P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION:<\/jats:title><jats:p>More than 6 months into the global pandemic, perceptions of COVID-19\u2013related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.<\/jats:p><\/jats:sec>","DOI":"10.1200\/op.21.00169","type":"journal-article","created":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T19:59:42Z","timestamp":1627588782000},"page":"e98-e107","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":7,"title":["Longitudinal Experience With and Impressions of COVID-19\u2013Related Clinical Research Changes"],"prefix":"10.1200","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7812-6741","authenticated-orcid":false,"given":"David E.","family":"Gerber","sequence":"first","affiliation":[{"name":"Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2277-4296","authenticated-orcid":false,"given":"Valerie L.","family":"Clark","sequence":"additional","affiliation":[{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9073-6334","authenticated-orcid":false,"given":"Thomas Y.","family":"Sheffield","sequence":"additional","affiliation":[{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3754-6627","authenticated-orcid":false,"given":"M. Shaalan","family":"Beg","sequence":"additional","affiliation":[{"name":"Division of Hematology-Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9456-1762","authenticated-orcid":false,"given":"Yang","family":"Xie","sequence":"additional","affiliation":[{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. E. Blair","family":"Holbein","sequence":"additional","affiliation":[{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2535-4476","authenticated-orcid":false,"given":"Celette Sugg","family":"Skinner","sequence":"additional","affiliation":[{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6345-1237","authenticated-orcid":false,"given":"Simon J. Craddock","family":"Lee","sequence":"additional","affiliation":[{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"},{"name":"Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4357-4111","authenticated-orcid":false,"given":"Erin L.","family":"Williams","sequence":"additional","affiliation":[{"name":"Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-1364"},{"key":"b2","first-page":"1","author":"Doherty GJ","year":"2020","journal-title":"Nat Cancer"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-20-0823"},{"volume-title":"Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected by COVID-19, Notice Number: NOT-OD-20-087","year":"2020","author":"National Institutes of Health","key":"b5"},{"key":"b6","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(97)00240-0"},{"key":"b7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2017.07.020"},{"key":"b8","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.62.1854"},{"key":"b9","doi-asserted-by":"publisher","DOI":"10.1200\/EDBK_155880"},{"key":"b10","doi-asserted-by":"publisher","DOI":"10.2217\/cer.15.27"},{"key":"b11","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2020.7643"},{"key":"b12","doi-asserted-by":"publisher","DOI":"10.1200\/JOP.2016.013060"},{"key":"b13","doi-asserted-by":"publisher","DOI":"10.1200\/JOP.2017.024349"},{"key":"b14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"b15","doi-asserted-by":"publisher","DOI":"10.1200\/OP.20.00275"},{"key":"b16","doi-asserted-by":"publisher","DOI":"10.1038\/nbt0718-561"},{"key":"b17","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n137"},{"key":"b18","doi-asserted-by":"crossref","first-page":"617","DOI":"10.1136\/jech-2020-214290","volume":"74","author":"Bonell C","year":"2020","journal-title":"J Epidemiol Community Health"},{"key":"b19","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2020.3976"},{"key":"b20","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.3972"}],"container-title":["JCO Oncology Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/OP.21.00169","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T17:09:46Z","timestamp":1699290586000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/OP.21.00169"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1]]}},"alternative-id":["10.1200\/OP.21.00169"],"URL":"https:\/\/doi.org\/10.1200\/op.21.00169","relation":{},"ISSN":["2688-1527","2688-1535"],"issn-type":[{"type":"print","value":"2688-1527"},{"type":"electronic","value":"2688-1535"}],"subject":[],"published":{"date-parts":[[2022,1]]},"assertion":[{"value":"2021-03-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-04-14","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-10","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}