The time is now: role of pragmatic clinical trials in guiding response to global pandemics

HIGHLIGHTS

  • who: Aws Almufleh from the Since, the FDA-Duke University collaboration project, titled the Clinical Trials Transformation Initiative, noted that most of the costs incurred in clinical trials are associated with human time and effort, mostly to ensure adequacy of completing required forms and repetitive site audits [8]Embracing risk-based central monitoring with automated data feeding will not only save resources but allow correcting deviations during trials as opposed to the predominant method of retrospective auditing. Furthermore, the use of information technology to streamline and facilitate regulatory requirements should be universally adopted. Finally, the burden of . . .

     

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