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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<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>
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<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>
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<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>
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