COVID-19

Impact of the COVID-19 Pandemic on the Collection and Analysis of Exposure/Drug Accountability in Ongoing Clinical Trials

This paper considers the impacts of COVID-19 on the collection and analysis of exposure/drug accountability data, offering guidance from industry experts on what clinical data scientists can expect in the short term, as well as consideration of future implications.

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Impact of the COVID-19 Pandemic on the Collection and Analysis of Missing Data in Ongoing Clinical Trials

The following blog discusses risks, mitigations, monitoring, and reporting of missing data for clinical trials conducted during the COVID-19 pandemic. These considerations are intended for clinical data scientists and are based on current practice, regulatory guidance and literature review. It is our intent to share these points to help inform our industry colleagues and suggest some best practices during this unprecedented time. We caution, however, that efforts are quickly evolving, and we are learning more each day. We look forward to your feedback as we travel this journey together.

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Impact of the COVID-19 Pandemic on the Collection and Analysis of Protocol Deviations in Ongoing Clinical Trials

The COVID-19 pandemic is an unprecedented event in the context of our clinical trials. It is, therefore, very important to understand the impact of the pandemic on our trials. Protocol Deviations are a key source of insight regarding the conduct of our trials related to ensuring patient safety and the integrity of our trial data.

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Impact of the COVID-19 Pandemic on the Collection and Analysis of Efficacy in Ongoing Clinical Trials

In this blog we will discuss key concepts related to the impact of COVID-19 specifically on programming. Impact on statistical inference will be considered in some parts of this article, but in-depth analysis of this is not within the scope of this article. This article is intended for trials which were ongoing during the COVID-19 pandemic, and not for trials specifically testing vaccines or treatments for COVID-19.

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Impacts of the COVID-19 Pandemic on the Collection and Analysis of Disposition and Concomitant Medications

This blog considers the impacts of COVID-19 on the collection and analysis of disposition and concomitant medications, offering guidance from industry experts on what clinical data scientists [1] (i.e. those who analyse data collected in clinical trials) can expect in the short term relating to the studies impacted by the COVID-19 pandemic, as well as consideration of future implications.

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