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Moving Clinical Operations Forward During Pandemic
Applied Clinical Trials ; 29(4):12-13, 2020.
Article in English | ProQuest Central | ID: covidwho-20241726
ABSTRACT
In the short and long term, sponsors should think through * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.
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Collection: Databases of international organizations Database: ProQuest Central Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Applied Clinical Trials Year: 2020 Document Type: Article

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Collection: Databases of international organizations Database: ProQuest Central Type of study: Prognostic study / Randomized controlled trials Language: English Journal: Applied Clinical Trials Year: 2020 Document Type: Article