{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:44:13Z","timestamp":1761864253836,"version":"3.40.5"},"reference-count":11,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,1,27]],"date-time":"2021-01-27T00:00:00Z","timestamp":1611705600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>The significance and prioritization of early phase oncology trial continuation during a global pandemic is unknown. This study reported the outcomes, multiple challenges, and broad recommendations associated with the impact of the novel coronavirus disease 2019 (COVID\u201019) on oncology early phase 1 trials\u2014and on drug development in Asia\u2014based on the experiences and perspectives of Asian oncology phase 1 centers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Between March and April 2020 during the initial period of outbreak, the impact of COVID\u201019 across oncology phase 1 sites in five Asian countries\u2014China (Hong Kong), Japan, South Korea, Taiwan, and Singapore\u2014was retrospectively analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was no trial termination or treatment discontinuation in all five countries. Although the most common impact was new patient enrollment being placed on hold, which was based on pharmaceutical sponsors\u2019 decision\u2010making, the situation varied per site. Most sites had no restrictions in place that would limit their ability to fully comply with the requirements of conducting the early phase studies. The number of protocol deviations during the pandemic was largely dependent on domestic transportation status during the outbreak rather than the ability of the clinical trial centers.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Determining the risk to benefits ratio of patients with cancer who are enrolled in early phase 1 clinical trials under the unusual circumstances of a global pandemic is important. Specific guidance or guidelines on the conduct of early phase 1 clinical trials during public health emergencies that are based on the recent lessons learned is urgently required.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ajco.13510","type":"journal-article","created":{"date-parts":[[2021,1,27]],"date-time":"2021-01-27T13:05:25Z","timestamp":1611752725000},"page":"388-395","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Overcoming the impact of the COVID\u201019 pandemic on oncology early phase trials and drug development in Asia\u2014Experiences and perspectives of the Asian Oncology Early Phase 1 Consortium"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6632-0638","authenticated-orcid":false,"given":"Toshio","family":"Shimizu","sequence":"first","affiliation":[{"name":"Early Phase 1 Drug Development Service Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dong\u2010Wan","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Clinical Trials Center Seoul National University Hospital  Seoul South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herbert H.","family":"Loong","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Centre The Chinese University of Hong Kong  Hong Kong SAR China"},{"name":"Department of Clinical Oncology State Key Laboratory of Translational Oncology The Chinese University of Hong Kong  Hong Kong SAR China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chia\u2010Chi","family":"Lin","sequence":"additional","affiliation":[{"name":"Phase 1 Center Department of Oncology National Taiwan University Hospital  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3170-4126","authenticated-orcid":false,"given":"Matthew CH","family":"Ng","sequence":"additional","affiliation":[{"name":"Experimental Cancer Therapeutics Unit Division of Medical Oncology National Cancer Centre Singapore  Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noboru","family":"Yamamoto","sequence":"additional","affiliation":[{"name":"Early Phase 1 Drug Development Service Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brigette","family":"Ma","sequence":"additional","affiliation":[{"name":"Phase 1 Clinical Trial Centre The Chinese University of Hong Kong  Hong Kong SAR China"},{"name":"Department of Clinical Oncology State Key Laboratory of Translational Oncology The Chinese University of Hong Kong  Hong Kong SAR China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel SW","family":"Tan","sequence":"additional","affiliation":[{"name":"Experimental Cancer Therapeutics Unit Division of Medical Oncology National Cancer Centre Singapore  Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,1,27]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"U.S. Food & Drug Administration.FDA guidance on conduct of clinical trials of medical products during COVID\u201019 public health emergency.Guidance for industry investigators and institutional review boards.https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergencyAccessed April 16 2020."},{"key":"e_1_2_8_3_1","unstructured":"European Medicines Agency.EMA guidance on the management of clinical trials during the COVID\u201019 (coronavirus) pandemic.https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol\u201010\/guidanceclinicaltrials_covid19_en.pdf#search=%27EMA\u00b1guidance\u00b1clinical\u00b1trial\u00b1COVID19%27. 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