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Preserving Trial Integrity During a Pandemic


The pharmaceutical industry is being impacted by the COVID-19 pandemic in ways not seen before. From decreased recruitment rates due to enforced social distancing policies, to a complete halt in drug development programmes as companies project their budgets. Trials are not being run as usual, and the pandemic’s effect on ongoing clinical trials may threaten scientific accuracy and regulatory compliance. However, with the correct changes and statistical methodologies in place, a study’s integrity can be preserved.

Sample Size: Are We Good or Not?

The right sample size ensures a successful study while balancing costs and minimising the number of patients undergoing potentially invasive procedures. We might think of continuing as planned until normality is restored, however, the costs of running a study that doesn’t deliver results in the agreed timelines can be overwhelming for major pharma companies, and a killer for smaller biotech companies.

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About the Author

Karen Ooms is responsible for overseeing the strategic delivery business unit for Quanticate. This includes the supervision of the clinical data management, biostatistics, programming, medical writing, and pharmacovigilance departments. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a senior statistician at Unilever.
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