Monthly News and Updates
The PHUSE Blog is full of engaging and insightful content. Over the past month we have had various blogs published, from PHUSE’s COVID-19 Task Force Project guidance documents to our virtual event success, to an insight into our new industry-leading platform, ON24.
Take a look below to catch up on the key content you may have missed.
PHUSE Guidance for Clinical Data Scientists: Dealing with the Impacts of COVID-19 on Clinical Study Data
Three of the seven guidance documents have been published so far. Click the links below to view them, and stay tuned on Mondays and Fridays for the next four!
1 – Impact of the COVID-19 Pandemic and Collection/Analysis of Adverse Events in Ongoing Trials
2 – Impact of the COVID-19 Pandemic and Collection/Analysis of Laboratory Data in Ongoing Clinical Trials
3 – Impact of the COVID-19 Pandemic on the Collection and Analysis of Disposition and Concomitant Medications
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. Regulatory authorities have released guidance documents focussing on the impacts to study start-up activities, changes to ongoing study procedures, and items considered urgent safety matters during this pandemic. Sponsors are having to react to both the pandemic and subjects with COVID-19 infections, as well as the impacts of the pandemic, such as site closures.
This series of blogs considers how COVID-19 may affect the work of a clinical data scientist in relation to ongoing studies, with suggestions concerning what new data might be required to understand the impact on a clinical study, how to process and how to analyse this data.
We will consider elements such as:
- What industry guidances are available?
- How do I process and report protocol deviations related to COVID-19?
- How do I process MedDRA terms including the new COVID-19 terms?
- How do Quality Threshold Limits affect me as a clinical data scientist in the context of the COVID-19 pandemic?
- What types of additional data and associated analysis/reporting are expected?
- Safety (i.e. AEs, Deaths, Discontinuations, Conmeds, Labs, Disposition)
- Efficacy (i.e. Missing Data, eCOA)
With virtual events now the new normal for the event world, PHUSE has invested in the industry-leading multimedia platform ON24 to host its virtual events. Take a look at this guide to view its functionality and what you can expect from a virtual PHUSE event.
The Virtual EU Connect 2020 saw near 250 submissions for its call for papers! With the virtualisation not restricting room size, Stream length, and potential topic conflicts, the Stream Chairs could focus their selection and discussions on one thing and one thing only – quality. Take a look at this blog piece written by Anne-Sophie Bekx, Connect Chair, for insight into what you can expect from the Connect event this November.
PHUSE is pleased to celebrate the success of its virtual Single Day Events. The virtualisation has allowed people across the globe to attend these usually regionally based events. Take a look at what has made our virtual events so successful, and hear from the Bengaluru SDE Chair, Shrishaila Patil.