Clinical trials for inflammatory bowel disease: a global guidance during COVID-19 pandemic.
Identifieur interne : 001320 ( Main/Exploration ); précédent : 001319; suivant : 001321Clinical trials for inflammatory bowel disease: a global guidance during COVID-19 pandemic.
Auteurs : Walter Reinisch [Autriche] ; Silvio Danese [Italie] ; Laurent Peyrin-Biroulet [France] ; Edward V. Loftus [États-Unis]Source :
- Journal of Crohn's & colitis [ 1876-4479 ] ; 2020.
Abstract
The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease to be recruited and maintained in clinical trials. However, clinical trials offer patients who have failed multiple drugs access to study medications with alternative mode of action and the potential for relief from inflammation-mediated symptoms. Therefore, the continuation of clinical trials in IBD during the COVID-19 pandemic is important both for participants and the community of IBD patients, due to the dire need of an expanded therapeutic armamentarium. As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.
DOI: 10.1093/ecco-jcc/jjaa119
PubMed: 32520311
PubMed Central: PMC7314066
Affiliations:
- Autriche, France, Italie, États-Unis
- Lorraine (région), Minnesota, Vienne (Autriche)
- Nancy, Vienne (Autriche)
- Centre hospitalier régional et universitaire de Nancy, Université de Lorraine
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Loftus</name><affiliation wicri:level="2"><nlm:affiliation>Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, U.S.A.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author></analytic><series><title level="j">Journal of Crohn's & colitis</title><idno type="eISSN">1876-4479</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease to be recruited and maintained in clinical trials. 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As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">32520311</PMID><DateRevised><Year>2020</Year><Month>06</Month><Day>26</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1876-4479</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Jun</Month><Day>10</Day></PubDate></JournalIssue><Title>Journal of Crohn's & colitis</Title><ISOAbbreviation>J Crohns Colitis</ISOAbbreviation></Journal><ArticleTitle>Clinical trials for inflammatory bowel disease: a global guidance during COVID-19 pandemic.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">jjaa119</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1093/ecco-jcc/jjaa119</ELocationID><Abstract><AbstractText>The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease to be recruited and maintained in clinical trials. However, clinical trials offer patients who have failed multiple drugs access to study medications with alternative mode of action and the potential for relief from inflammation-mediated symptoms. Therefore, the continuation of clinical trials in IBD during the COVID-19 pandemic is important both for participants and the community of IBD patients, due to the dire need of an expanded therapeutic armamentarium. As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.</AbstractText><CopyrightInformation>© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Reinisch</LastName><ForeName>Walter</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine III, Division Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Danese</LastName><ForeName>Silvio</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Inflammatory Bowel Disease Center, Humanitas University, IRCCS Humanitas Research Hospital, Milano, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peyrin-Biroulet</LastName><ForeName>Laurent</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Inserm NGERE U1256 and Department of Gastroenterology, Nancy University Hospital, Lorraine University, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Loftus</LastName><ForeName>Edward V</ForeName><Initials>EV</Initials><AffiliationInfo><Affiliation>Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, U.S.A.</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>10</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Crohns Colitis</MedlineTA><NlmUniqueID>101318676</NlmUniqueID><ISSNLinking>1873-9946</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>6</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>6</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>6</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32520311</ArticleId><ArticleId IdType="pii">5855532</ArticleId><ArticleId IdType="doi">10.1093/ecco-jcc/jjaa119</ArticleId><ArticleId IdType="pmc">PMC7314066</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Autriche</li><li>France</li><li>Italie</li><li>États-Unis</li></country><region><li>Lorraine (région)</li><li>Minnesota</li><li>Vienne (Autriche)</li></region><settlement><li>Nancy</li><li>Vienne (Autriche)</li></settlement><orgName><li>Centre hospitalier régional et universitaire de Nancy</li><li>Université de Lorraine</li></orgName></list><tree><country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Reinisch, Walter" sort="Reinisch, Walter" uniqKey="Reinisch W" first="Walter" last="Reinisch">Walter Reinisch</name></region></country><country name="Italie"><noRegion><name sortKey="Danese, Silvio" sort="Danese, Silvio" uniqKey="Danese S" first="Silvio" last="Danese">Silvio Danese</name></noRegion></country><country name="France"><region name="Lorraine (région)"><name sortKey="Peyrin Biroulet, Laurent" sort="Peyrin Biroulet, Laurent" uniqKey="Peyrin Biroulet L" first="Laurent" last="Peyrin-Biroulet">Laurent Peyrin-Biroulet</name></region></country><country name="États-Unis"><region name="Minnesota"><name sortKey="Loftus, Edward V" sort="Loftus, Edward V" uniqKey="Loftus E" first="Edward V" last="Loftus">Edward V. 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