COVID-19 effect on clinical research: Single-site risk management experience.
Identifieur interne : 000755 ( Main/Exploration ); précédent : 000754; suivant : 000756COVID-19 effect on clinical research: Single-site risk management experience.
Auteurs : Fatma Soliman Elsayed Ebeid [Égypte]Source :
- Perspectives in clinical research [ 2229-3485 ]
Abstract
Background
The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come.
Aim
The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact.
Methodology
Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center.
Results
Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually.
Conclusion
The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan.
DOI: 10.4103/picr.PICR_119_20
PubMed: 33033698
PubMed Central: PMC7513789
Affiliations:
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It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come.</p></div><div type="abstract" xml:lang="en"><p><b>Aim</b></p><p>The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact.</p></div><div type="abstract" xml:lang="en"><p><b>Methodology</b></p><p>Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusion</b></p><p>The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33033698</PMID><DateRevised><Year>2020</Year><Month>10</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">2229-3485</ISSN><JournalIssue CitedMedium="Print"><Volume>11</Volume><Issue>3</Issue><PubDate><MedlineDate>2020 Jul-Sep</MedlineDate></PubDate></JournalIssue><Title>Perspectives in clinical research</Title><ISOAbbreviation>Perspect Clin Res</ISOAbbreviation></Journal><ArticleTitle>COVID-19 effect on clinical research: Single-site risk management experience.</ArticleTitle><Pagination><MedlinePgn>106-110</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.4103/picr.PICR_119_20</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">The ongoing coronavirus disease 2019 (COVID-19) pandemic is extensively impacting new and ongoing clinical trials of various medical products irrespective of indication. It has the potential to adverse effect not only in terms of recruitment and immediate patient care but is also likely to affect the data collection and analysis in the months to come.</AbstractText><AbstractText Label="Aim" NlmCategory="UNASSIGNED">The aim was to illustrate the effect of COVID-19 on the clinical research in one of the research centers in low limited-resource country as Egypt and the management plan performed to decrease this adverse impact.</AbstractText><AbstractText Label="Methodology" NlmCategory="UNASSIGNED">Secondary data were collected anonymously about the measures implemented to deal with the challenges of conducting the nine ongoing and new clinical researches during COVID-19 pandemic at Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">Out of the 47 enrolled participants, thirty participants required investigational product (IP) dispensation during the remaining study period; 27 of them had their IP dispensed at site, and six participants who were from far away Governorate were not able to come to the center due to the partial lockdown and had their IP deliver through courier to their home. Safety laboratory assessment had performed at the site or local laboratory at their hometown. Virtual visit alternatives to in-person visits for communication and patient evaluation had been performed. Recruitment of new participants and opening new sites were stopped in many trials. In order to reduce the on-site activities, in particular, on-site monitoring, all monitoring visits were performed virtually.</AbstractText><AbstractText Label="Conclusion" NlmCategory="UNASSIGNED">The adverse impact of COVID-19 pandemic on clinical trials could be lessening by active management plan.</AbstractText><CopyrightInformation>Copyright: © 2020 Perspectives in Clinical Research.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ebeid</LastName><ForeName>Fatma Soliman Elsayed</ForeName><Initials>FSE</Initials><AffiliationInfo><Affiliation>Department of Pediatric Hematology Oncology, Faculty of Medicine, Ain Shams University Research Institute-Clinical Research Center, Cairo, Egypt.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>India</Country><MedlineTA>Perspect Clin Res</MedlineTA><NlmUniqueID>101551517</NlmUniqueID><ISSNLinking>2229-3485</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Clinical research</Keyword><Keyword MajorTopicYN="N">clinical trials</Keyword><Keyword MajorTopicYN="N">coronavirus</Keyword><Keyword MajorTopicYN="N">coronavirus disease 2019</Keyword></KeywordList><CoiStatement>There are no conflicts of interest.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>05</Month><Day>02</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2020</Year><Month>05</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>06</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>10</Month><Day>9</Day><Hour>5</Hour><Minute>39</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>10</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>10</Month><Day>10</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33033698</ArticleId><ArticleId IdType="doi">10.4103/picr.PICR_119_20</ArticleId><ArticleId IdType="pii">PCR-11-106</ArticleId><ArticleId IdType="pmc">PMC7513789</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Lancet. 2020 Feb 15;395(10223):497-506</Citation><ArticleIdList><ArticleId IdType="pubmed">31986264</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Apr 30;382(18):1708-1720</Citation><ArticleIdList><ArticleId IdType="pubmed">32109013</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Invest. 2020 Apr 1;130(4):1545-1548</Citation><ArticleIdList><ArticleId IdType="pubmed">32167489</ArticleId></ArticleIdList></Reference><Reference><Citation>MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):458-464</Citation><ArticleIdList><ArticleId IdType="pubmed">32298251</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Égypte</li></country></list><tree><country name="Égypte"><noRegion><name sortKey="Ebeid, Fatma Soliman Elsayed" sort="Ebeid, Fatma Soliman Elsayed" uniqKey="Ebeid F" first="Fatma Soliman Elsayed" last="Ebeid">Fatma Soliman Elsayed Ebeid</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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