COVID-19

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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Impact of the COVID-19 Pandemic and Collection/Analysis of Laboratory Data in Ongoing Clinical Trials

Since late 2019/early 2020, the global COVID-19 pandemic has impacted all aspects of daily life. Ongoing clinical trials have been impacted in multiple ways, including but not limited to delays in screening and enrolment of subjects into trials, challenges with maintaining the trial schedule for ongoing subjects due to temporary site closures, lack of continuous drug supply, and subjects experiencing new and unexpected adverse events. The safety of clinical trial participants must be ensured despite these challenges.

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Impact of the COVID-19 Pandemic and Collection/Analysis of Adverse Events Data in Ongoing Trials

This blog considers the impacts of COVID-19 on the collection and analysis of adverse events, 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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Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

With the COVID-19 pandemic thoughts have turned to how to address the impact of the virus and measures taken to suppress it have had on clinical studies. In the last few weeks two papers providing analysis recommendations from clinical trials impacted by COVID-19 have been prepared by a cross-industry group and submitted to Statistics in Biopharmaceutical Research.

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The Impacts of COVID-19 on Clinical Trial Transparency and Document Disclosure PHUSE CTT Project

As the COVID-19 pandemic severely impacts many facets of human activity around the world, the pharmaceutical industry is being presented with significant challenges related to the manufacturing and shipping of existing marketed products and to treatment development activities.

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PHUSE is an expanding, global society with a global membership of clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

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