Will you be ready to reopen clinical trials?

Posted by Chris Crabtree on Thu, Apr 23, 2020

Ben Thomas co-wrote this post with Chris Crabtree

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The COVID-19 outbreak has led to increased interest in the development of new vaccines and anti-viral therapies. Although this spike of attention on R&D should be welcomed, many members of the public remain unaware of the negative impact that COVID-19 is having on the development of therapies for other conditions. With more than three-quarters of trial sites reporting an impact of COVID-19, sponsors across the industry are pausing screening and enrollment in the interests of patient safety and data integrity. The implication is that COVID-19 will inevitably lead to a significant delay in getting new therapies to patients who need them.


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How should biopharma companies prioritize their pipeline programs during COVID-19?

Posted by Padma Gunda on Wed, Apr 08, 2020

Jared Selsberg co-wrote this blog post with Padma Gunda

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Independent of the current pandemic, life sciences companies frequently reevaluate their product pipeline programs on a variety of dynamic clinical and commercial factors. With COVID-19 reshaping healthcare and introducing widespread clinical trial delays, the calculus for pipeline prioritization has changed. When reprioritizing programs now, we believe that pharma companies should focus on trials for life-threatening conditions, protect patient safety and limit the use of hospital resources.


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Clinical Development Risks and Issues in a COVID-19 World

Posted by Jonathan Rowe on Fri, Mar 20, 2020

Global clinical guidelines have shifted the industry toward risk-based approaches for the planning and execution of clinical trials. The ICH’s guidelines for Good Clinical Practice state that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH E6 R2).


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