About: Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials during the Coronavirus-19 Pandemic.

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About: Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials during the Coronavirus-19 Pandemic. Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials during the Coronavirus-19 Pandemic.
Creator	Bowdish, Michael Emamaullee, Juliet Rodina, Valentina Sher, Linda Yan, Pui Yan, Yuk
Source	Elsevier; Medline; PMC; WHO
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 non-essential 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.
has issue date	2020-06-29(xsd:dateTime)
bibo:doi	10.1016/j.jss.2020.06.049
bibo:pmid	32683060
has license	no-cc
sha1sum (hex)	4d7aa7e498d0c47b17779ab6e58b30abc7485aa4
schema:url	https://doi.org/10.1016/j.jss.2020.06.049
resource representing a document's title	Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials during the Coronavirus-19 Pandemic.
has PubMed Central identifier	PMC7323687
has PubMed identifier	32683060
schema:publication	J Surg Res
resource representing a document's body	covid:4d7aa7e498d0c47b17779ab6e58b30abc7485aa4#body_text
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