Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic.
Identifieur interne : 000D72 ( Main/Exploration ); précédent : 000D71; suivant : 000D73Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic.
Auteurs : Juliet Emamaullee [États-Unis] ; Michael Bowdish [États-Unis] ; Pui Yuk Yan [États-Unis] ; Valentina Rodina [États-Unis] ; Linda S. Sher [États-Unis]Source :
- The Journal of surgical research [ 1095-8673 ] ; 2020.
Descripteurs français
- KwdFr :
- Californie (MeSH), Département hospitalier de chirurgie (organisation et administration), Département hospitalier de chirurgie (statistiques et données numériques), Département hospitalier de chirurgie (tendances), Essais cliniques comme sujet (organisation et administration), Essais cliniques comme sujet (statistiques et données numériques), Humains (MeSH), Hôpitaux universitaires (organisation et administration), Hôpitaux universitaires (statistiques et données numériques), Hôpitaux universitaires (tendances), Pandémies (prévention et contrôle), Sécurité des patients (MeSH), Sélection de patients (MeSH).
- MESH :
- organisation et administration : Département hospitalier de chirurgie, Essais cliniques comme sujet, Hôpitaux universitaires.
- prévention et contrôle : Pandémies.
- statistiques et données numériques : Département hospitalier de chirurgie, Essais cliniques comme sujet, Hôpitaux universitaires.
- tendances : Département hospitalier de chirurgie, Hôpitaux universitaires.
- Californie, Humains, Sécurité des patients, Sélection de patients.
English descriptors
- KwdEn :
- COVID-19 (epidemiology), COVID-19 (therapy), California (MeSH), Clinical Trials as Topic (organization & administration), Clinical Trials as Topic (statistics & numerical data), Hospitals, University (organization & administration), Hospitals, University (statistics & numerical data), Hospitals, University (trends), Humans (MeSH), Pandemics (prevention & control), Patient Safety (MeSH), Patient Selection (MeSH), Physical Distancing (MeSH), Surgery Department, Hospital (organization & administration), Surgery Department, Hospital (statistics & numerical data), Surgery Department, Hospital (trends).
- MESH :
- geographic : California.
- epidemiology : COVID-19.
- organization & administration : Clinical Trials as Topic, Hospitals, University, Surgery Department, Hospital.
- prevention & control : Pandemics.
- statistics & numerical data : Clinical Trials as Topic, Hospitals, University, Surgery Department, Hospital.
- therapy : COVID-19.
- trends : Hospitals, University, Surgery Department, Hospital.
- Humans, Patient Safety, Patient Selection, Physical Distancing.
Abstract
The coronavirus disease 2019 (COVID-19) pandemic has brought most ongoing clinical trials to a standstill, while at the same time emphasizing the need for new therapeutic treatments and strategies to mitigate the morbidity and mortality related to COVID-19. Recent publication of several observational studies has generated much discussion surrounding efficacy of drugs including hydroxychloroquine, azithromycin, and remdesivir, stressing the need for high-quality prospective, randomized control trials in patients with COVID-19. Ongoing "stay at home" orders and institutional policies mandating "work from home" for nonessential employees, which includes most research personnel, have impacted the ability to implement and conduct clinical studies. This article discusses the approach of an experienced clinical trials unit to make adjustments for ongoing studies and ensure the safety of study participants. At the same time, plans were implemented to continue collection of data to achieve endpoints, safely enroll and follow participants in studies offering potential benefit, and quickly implement new COVID-19 clinical trials. The existence of a Division of Clinical Research with regulatory, budgeting, contracting, and coordinating expertise within a department of surgery can successfully accommodate a crisis situation and rapidly adapt to new requirements for the safe, efficient, and effective conversion to a remote work force without compromising the research process.
DOI: 10.1016/j.jss.2020.06.049
PubMed: 32683060
PubMed Central: PMC7323687
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Sher</name><affiliation wicri:level="4"><nlm:affiliation>Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region><settlement type="city">Los Angeles</settlement></placeName><wicri:cityArea>Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles</wicri:cityArea><orgName type="university">Université de Californie du Sud</orgName></affiliation></author></analytic><series><title level="j">The Journal of surgical research</title><idno type="eISSN">1095-8673</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COVID-19 (epidemiology)</term><term>COVID-19 (therapy)</term><term>California (MeSH)</term><term>Clinical Trials as Topic (organization & administration)</term><term>Clinical Trials as Topic (statistics & numerical data)</term><term>Hospitals, University (organization & administration)</term><term>Hospitals, University (statistics & numerical data)</term><term>Hospitals, University (trends)</term><term>Humans (MeSH)</term><term>Pandemics (prevention & control)</term><term>Patient Safety (MeSH)</term><term>Patient Selection (MeSH)</term><term>Physical Distancing (MeSH)</term><term>Surgery Department, Hospital (organization & administration)</term><term>Surgery Department, Hospital (statistics & numerical data)</term><term>Surgery Department, Hospital (trends)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Californie (MeSH)</term><term>Département hospitalier de chirurgie (organisation et administration)</term><term>Département hospitalier de chirurgie (statistiques et données numériques)</term><term>Département hospitalier de chirurgie (tendances)</term><term>Essais cliniques comme sujet (organisation et administration)</term><term>Essais cliniques comme sujet (statistiques et données numériques)</term><term>Humains (MeSH)</term><term>Hôpitaux universitaires (organisation et administration)</term><term>Hôpitaux universitaires (statistiques et données numériques)</term><term>Hôpitaux universitaires (tendances)</term><term>Pandémies (prévention et contrôle)</term><term>Sécurité des patients (MeSH)</term><term>Sélection de patients (MeSH)</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>California</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="organisation et administration" xml:lang="fr"><term>Département hospitalier de chirurgie</term><term>Essais cliniques comme sujet</term><term>Hôpitaux universitaires</term></keywords><keywords scheme="MESH" qualifier="organization & administration" xml:lang="en"><term>Clinical Trials as Topic</term><term>Hospitals, University</term><term>Surgery Department, Hospital</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Pandemics</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Pandémies</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Clinical Trials as Topic</term><term>Hospitals, University</term><term>Surgery Department, Hospital</term></keywords><keywords scheme="MESH" qualifier="statistiques et données numériques" xml:lang="fr"><term>Département hospitalier de chirurgie</term><term>Essais cliniques comme sujet</term><term>Hôpitaux universitaires</term></keywords><keywords scheme="MESH" qualifier="tendances" xml:lang="fr"><term>Département hospitalier de chirurgie</term><term>Hôpitaux universitaires</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="trends" xml:lang="en"><term>Hospitals, University</term><term>Surgery Department, Hospital</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Patient Safety</term><term>Patient Selection</term><term>Physical Distancing</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Californie</term><term>Humains</term><term>Sécurité des patients</term><term>Sélection de patients</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The coronavirus disease 2019 (COVID-19) pandemic has brought most ongoing clinical trials to a standstill, while at the same time emphasizing the need for new therapeutic treatments and strategies to mitigate the morbidity and mortality related to COVID-19. Recent publication of several observational studies has generated much discussion surrounding efficacy of drugs including hydroxychloroquine, azithromycin, and remdesivir, stressing the need for high-quality prospective, randomized control trials in patients with COVID-19. Ongoing "stay at home" orders and institutional policies mandating "work from home" for nonessential employees, which includes most research personnel, have impacted the ability to implement and conduct clinical studies. This article discusses the approach of an experienced clinical trials unit to make adjustments for ongoing studies and ensure the safety of study participants. At the same time, plans were implemented to continue collection of data to achieve endpoints, safely enroll and follow participants in studies offering potential benefit, and quickly implement new COVID-19 clinical trials. The existence of a Division of Clinical Research with regulatory, budgeting, contracting, and coordinating expertise within a department of surgery can successfully accommodate a crisis situation and rapidly adapt to new requirements for the safe, efficient, and effective conversion to a remote work force without compromising the research process.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32683060</PMID><DateCompleted><Year>2021</Year><Month>03</Month><Day>01</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>01</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1095-8673</ISSN><JournalIssue CitedMedium="Internet"><Volume>256</Volume><PubDate><Year>2020</Year><Month>12</Month></PubDate></JournalIssue><Title>The Journal of surgical research</Title><ISOAbbreviation>J Surg Res</ISOAbbreviation></Journal><ArticleTitle>Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic.</ArticleTitle><Pagination><MedlinePgn>76-82</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0022-4804(20)30442-X</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jss.2020.06.049</ELocationID><Abstract><AbstractText>The coronavirus disease 2019 (COVID-19) pandemic has brought most ongoing clinical trials to a standstill, while at the same time emphasizing the need for new therapeutic treatments and strategies to mitigate the morbidity and mortality related to COVID-19. Recent publication of several observational studies has generated much discussion surrounding efficacy of drugs including hydroxychloroquine, azithromycin, and remdesivir, stressing the need for high-quality prospective, randomized control trials in patients with COVID-19. Ongoing "stay at home" orders and institutional policies mandating "work from home" for nonessential employees, which includes most research personnel, have impacted the ability to implement and conduct clinical studies. This article discusses the approach of an experienced clinical trials unit to make adjustments for ongoing studies and ensure the safety of study participants. At the same time, plans were implemented to continue collection of data to achieve endpoints, safely enroll and follow participants in studies offering potential benefit, and quickly implement new COVID-19 clinical trials. The existence of a Division of Clinical Research with regulatory, budgeting, contracting, and coordinating expertise within a department of surgery can successfully accommodate a crisis situation and rapidly adapt to new requirements for the safe, efficient, and effective conversion to a remote work force without compromising the research process.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Emamaullee</LastName><ForeName>Juliet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles, California. Electronic address: Juliet.emamaullee@med.usc.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bowdish</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yan</LastName><ForeName>Pui Yuk</ForeName><Initials>PY</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Southern California, Los Angeles, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rodina</LastName><ForeName>Valentina</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Southern California, Los Angeles, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sher</LastName><ForeName>Linda S</ForeName><Initials>LS</Initials><AffiliationInfo><Affiliation>Department of Surgery, University of Southern California, Los Angeles, California; Keck School of Medicine, University of Southern California, Los Angeles, California.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>06</Month><Day>29</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Surg Res</MedlineTA><NlmUniqueID>0376340</NlmUniqueID><ISSNLinking>0022-4804</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002140" MajorTopicYN="N" Type="Geographic">California</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="N">Clinical Trials as Topic</DescriptorName><QualifierName UI="Q000458" MajorTopicYN="Y">organization & administration</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006785" MajorTopicYN="N">Hospitals, University</DescriptorName><QualifierName UI="Q000458" MajorTopicYN="N">organization & administration</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName><QualifierName UI="Q000639" MajorTopicYN="N">trends</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061214" MajorTopicYN="N">Patient Safety</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018579" MajorTopicYN="N">Patient Selection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000085762" MajorTopicYN="Y">Physical Distancing</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013503" MajorTopicYN="N">Surgery Department, Hospital</DescriptorName><QualifierName UI="Q000458" MajorTopicYN="Y">organization & administration</QualifierName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName><QualifierName UI="Q000639" MajorTopicYN="N">trends</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19 pandemic</Keyword><Keyword MajorTopicYN="Y">Clinical trials unit</Keyword><Keyword MajorTopicYN="Y">SARS-CoV-2</Keyword><Keyword MajorTopicYN="Y">Surgical Research</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>28</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>06</Month><Day>18</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>06</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>7</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>3</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>7</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32683060</ArticleId><ArticleId IdType="pii">S0022-4804(20)30442-X</ArticleId><ArticleId IdType="doi">10.1016/j.jss.2020.06.049</ArticleId><ArticleId IdType="pmc">PMC7323687</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li></region><settlement><li>Los Angeles</li></settlement><orgName><li>Université de Californie du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Californie"><name sortKey="Emamaullee, Juliet" sort="Emamaullee, Juliet" uniqKey="Emamaullee J" first="Juliet" last="Emamaullee">Juliet Emamaullee</name></region><name sortKey="Bowdish, Michael" sort="Bowdish, Michael" uniqKey="Bowdish M" first="Michael" last="Bowdish">Michael Bowdish</name><name sortKey="Rodina, Valentina" sort="Rodina, Valentina" uniqKey="Rodina V" first="Valentina" last="Rodina">Valentina Rodina</name><name sortKey="Sher, Linda S" sort="Sher, Linda S" uniqKey="Sher L" first="Linda S" last="Sher">Linda S. Sher</name><name sortKey="Yan, Pui Yuk" sort="Yan, Pui Yuk" uniqKey="Yan P" first="Pui Yuk" last="Yan">Pui Yuk Yan</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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