{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T06:35:02Z","timestamp":1768890902237,"version":"3.49.0"},"reference-count":0,"publisher":"Harborside Press, LLC","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. <jats:bold>Methods:<\/jats:bold> We developed and distributed an anonymous survey assessing COVID-19\u2013related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. <jats:bold>Results:<\/jats:bold> A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had &gt;5 years\u2019 professional experience in clinical research, and 56% had personal experience with a COVID-19\u2013related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with &gt;5 years\u2019 professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (<jats:italic>P<\/jats:italic>=.04) and therapy shipment (<jats:italic>P<\/jats:italic>=.02). <jats:bold>Conclusions:<\/jats:bold> Clinical research professionals perceive that COVID-19\u2013related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience\u2014both specific to COVID-19\u2013related changes and more generally\u2014are more likely to recommend that these adjustments continue in the future.<\/jats:p>","DOI":"10.6004\/jnccn.2020.7643","type":"journal-article","created":{"date-parts":[[2021,11,26]],"date-time":"2021-11-26T15:56:18Z","timestamp":1637942178000},"page":"505-512","source":"Crossref","is-referenced-by-count":19,"title":["Experience, Perceptions, and Recommendations Concerning COVID-19\u2013Related Clinical Research Adjustments"],"prefix":"10.6004","volume":"19","author":[{"given":"David E.","family":"Gerber","sequence":"first","affiliation":[{"name":"1Department of Internal Medicine, Division of Hematology-Oncology,"},{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"},{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas Y.","family":"Sheffield","sequence":"additional","affiliation":[{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Shaalan","family":"Beg","sequence":"additional","affiliation":[{"name":"1Department of Internal Medicine, Division of Hematology-Oncology,"},{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erin L.","family":"Williams","sequence":"additional","affiliation":[{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerie L.","family":"Clark","sequence":"additional","affiliation":[{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang","family":"Xie","sequence":"additional","affiliation":[{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"},{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M.E. Blair","family":"Holbein","sequence":"additional","affiliation":[{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Celette Sugg","family":"Skinner","sequence":"additional","affiliation":[{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"},{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon J. Craddock","family":"Lee","sequence":"additional","affiliation":[{"name":"2Harold C. Simmons Comprehensive Cancer Center, and"},{"name":"3Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"4047","container-title":["Journal of the National Comprehensive Cancer Network"],"original-title":[],"link":[{"URL":"https:\/\/jnccn.org\/view\/journals\/jnccn\/19\/5\/article-p505.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/jnccn.org\/downloadpdf\/journals\/jnccn\/19\/5\/article-p505.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,11,26]],"date-time":"2021-11-26T15:56:18Z","timestamp":1637942178000},"score":1,"resource":{"primary":{"URL":"https:\/\/jnccn.org\/view\/journals\/jnccn\/19\/5\/article-p505.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5]]},"references-count":0,"journal-issue":{"issue":"5"},"URL":"https:\/\/doi.org\/10.6004\/jnccn.2020.7643","relation":{},"ISSN":["1540-1405","1540-1413"],"issn-type":[{"value":"1540-1405","type":"print"},{"value":"1540-1413","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5]]}}}