{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:14:55Z","timestamp":1787019295240,"version":"build-2736575974"},"reference-count":17,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2023,2,11]],"date-time":"2023-02-11T00:00:00Z","timestamp":1676073600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000969","name":"Australian Academy of Science","doi-asserted-by":"publisher","award":["Australian Academy of Science Regional Collaborati"],"award-info":[{"award-number":["Australian Academy of Science Regional Collaborati"]}],"id":[{"id":"10.13039\/501100000969","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000969","name":"Australian Academy of Science","doi-asserted-by":"publisher","award":["Regional Collaborations Programme COVID-19 Digital"],"award-info":[{"award-number":["Regional Collaborations Programme COVID-19 Digital"]}],"id":[{"id":"10.13039\/501100000969","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-024389"],"award-info":[{"award-number":["INV-024389"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1164105\/INV-010504"],"award-info":[{"award-number":["OPP1164105\/INV-010504"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1182950"],"award-info":[{"award-number":["APP1182950"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP2000780"],"award-info":[{"award-number":["APP2000780"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["GNT1132975"],"award-info":[{"award-number":["GNT1132975"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The COVID-19 pandemic and resulting restrictions, particularly travel restrictions, have had significant impact on the conduct of global clinical trials. Our clinical trials programme, which relied on in-person visits for training, monitoring and capacity building across nine low- and middle-income countries, had to adapt to those unprecedented operational challenges. We report the adaptation of our working model with a focus on the operational areas of training, monitoring and cross-site collaboration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>The new working model:<\/jats:title>\n                    <jats:p>Adaptations include changing training strategies from in-person site visits with three or four team members to a multi-pronged virtual approach, with generic online training for good clinical practice, the development of a library of study-specific training videos, and interactive virtual training sessions, including practical laboratory-focused training sessions. We also report changes from in-person monitoring to remote monitoring as well as the development of a more localized network of clinical trial monitors to support hybrid models with in-person and remote monitoring depending on identified risks at each site. We established a virtual network across different trial and study sites with the objective to further build capacity for good clinical practice\u2013compliant antimalarial trials and foster cross-country and cross-study site collaboration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The forced adaptation of these new strategies has come with advantages that we did not envisage initially. This includes improved, more frequent engagement through the established network with opportunities for increased south-to-south support and a substantially reduced carbon footprint and budget savings. Our new approach is challenging for study sites with limited prior experience but this can be overcome with hybrid models. Capacity building for laboratory-based work remains difficult using a virtual environment. The changes to our working model are likely to last, even after the end of the pandemic, providing a more sustainable and equitable approach to our research.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745231154215","type":"journal-article","created":{"date-parts":[[2023,2,11]],"date-time":"2023-02-11T03:33:36Z","timestamp":1676086416000},"page":"237-241","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Adapting international clinical trials during COVID-19 and beyond"],"prefix":"10.1177","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7536-7497","authenticated-orcid":false,"given":"Kamala","family":"Thriemer","sequence":"first","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamiru Shibiru","family":"Degaga","sequence":"additional","affiliation":[{"name":"College of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8330-5499","authenticated-orcid":false,"given":"Mohammad Shafiul","family":"Alam","sequence":"additional","affiliation":[{"name":"International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka, Bangladesh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bipin","family":"Adhikari","sequence":"additional","affiliation":[{"name":"Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupam","family":"Tripura","sequence":"additional","affiliation":[{"name":"Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9876-7722","authenticated-orcid":false,"given":"Mohammad Sharif","family":"Hossain","sequence":"additional","affiliation":[{"name":"International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR, B), Dhaka, Bangladesh"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Christian","sequence":"additional","affiliation":[{"name":"Eijkman-Oxford Clinical Research Unit, Jakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Najia K","family":"Ghanchi","sequence":"additional","affiliation":[{"name":"Department of Pathology and Microbiology, Aga Khan University, Karachi, Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hellen","family":"Mnjala","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Weston","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedikt","family":"Ley","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela","family":"Rumaseb","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3770-1957","authenticated-orcid":false,"given":"Dagimawie","family":"Tadesse","sequence":"additional","affiliation":[{"name":"College of Medicine & Health Sciences, Arba Minch University, Arba Minch, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tedla","family":"Teferi","sequence":"additional","affiliation":[{"name":"Arba Minch General Hospital, Arba Minch, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Yilma","sequence":"additional","affiliation":[{"name":"Jimma University, Jimma, Ethiopia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8495-0553","authenticated-orcid":false,"given":"Grant","family":"Lee","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"Unger","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge","family":"Sutanto","sequence":"additional","affiliation":[{"name":"Department of Parasitology, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayodhia Pitaloka","family":"Pasaribu","sequence":"additional","affiliation":[{"name":"Department of Child Health, Universitas Sumatera Utara, Medan, Indonesia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2503-412X","authenticated-orcid":false,"given":"Prakash","family":"Ghimire","sequence":"additional","affiliation":[{"name":"Central Department of Microbiology, Tribhuvan University, Kirtipur, Nepal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammad Asim","family":"Beg","sequence":"additional","affiliation":[{"name":"Department of Pathology and Microbiology, Aga Khan University, Karachi, Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ric N","family":"Price","sequence":"additional","affiliation":[{"name":"Global and Tropical Health Division, Menzies School of Health Research and Charles Darwin University, Darwin, NT, Australia"},{"name":"Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand"},{"name":"Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,2,11]]},"reference":[{"key":"bibr1-17407745231154215","first-page":"157","volume":"91","author":"Cucinotta D","year":"2020","journal-title":"Acta Biomed"},{"key":"bibr2-17407745231154215","doi-asserted-by":"publisher","DOI":"10.3126\/nje.v10i3.31622"},{"key":"bibr3-17407745231154215","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000004113"},{"key":"bibr4-17407745231154215","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31787-6"},{"key":"bibr5-17407745231154215","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-021-05219-3"},{"key":"bibr6-17407745231154215","unstructured":"National Institute for Health and Care Research (NIHR). 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