Throughout this blog series, we will be discussing how the COVID-19 pandemic situation has affected clinical trials, focussing on the pertinent statistical issues and associated key recommendations. Rather than providing an exhaustive summary of all potential issues and possible solutions, the aim is to concentrate on the key areas and questions that statisticians on project teams should be asking and thinking about. Whilst there are important aspects regarding safety data, the focus of this series is on the considerations for efficacy data and so the main points covered are estimands and missing data.
The World Health Organisation (WHO) declared COVID-19 a global pandemic on 11th March 2020 and the subsequent restrictions on everyday life caused significant disruption to clinical trials. The full extent of the impact of COVID-19 will not be known for some time but the effect on clinical trials will most certainly be significant. Although sponsors have been quick to make changes to clinical trials there will undoubtably still be many issues to address. The range of disruptions of COVID-19 to clinical trials are expected to be so diverse that no single solution will be appropriate for all trials. It is likely that each trial will need to be assessed on a case-by-case basis, although there will be many common issues. It is critical for sponsors and regulators to work together and make the best use of clinical trials affected by COVID-19. Collaboration and sharing of learnings during the pandemic are going to be vitally important for a long time to come.
Written by Prof. Jennifer Rogers on . Posted in Blog
On 22nd October, PHASTAR’s Vice President for Statistical Research and Consultancy, Jennifer Rogers, appeared on BBC Radio 5 Live (Click Here for Radio 5 Live Interviewwhich starts at 12:50) to discuss the latest COVID-19 statistics and one of the questions that she was asked considered the expected split of vaccinated versus unvaccinated people in hospital throughout the potential “winter wave”. Here Jen looks at hospitalisation data for vaccinated versus unvaccinated people in more detail and argues that the wrong questions are being asked.
On the 19th July, Sir Patrick Vallance announced that 60% of people in hospital from COVID-19 in the UK were not from double vaccinated people (after a brief bit of confusion when he mistakenly said in the press conference that 60% of people in hospital were double vaccinated). This means that 40% of people in hospital from COVID-19 were double vaccinated. Following this, we have seen the percentage of people in hospital being vaccinated versus unvaccinated be repeatedly reported as a useful statistic.
As world leaders gather at COP26 in Glasgow to tackle climate change on a global level, here at PHASTAR we have the responsibility to do our part and are therefore implementing a comprehensive, corporate Environmental, Social, and Governance (ESG) strategy.
Yesterday our CEO, Andrew MacGarvey, unveiled PHASTAR’s ESG strategic plan and key imperatives, and announced the launch of one of the first initiatives - the rewilding and revitalization of a once wild forest area - where we will plant a tree for each current member of PHASTAR staff as well as for every one of our PHASTAR alumni family.
Additionally, PHASTAR is engaging in a Carbon Offset programme to balance out our carbon footprint, a component of which is the audit of all our current energy providers so that we can transition to using only green energy suppliers.
Written by Prof. Jennifer Rogers on . Posted in Blog
COVID-19 is taking over the headlines once again as cases seem to be on the rise. Alongside this, there have been the inevitable discussions among politicians and the media about whether this “surge” in cases will result in restrictions being reintroduced. But are these discussions warranted? Here, PHASTAR’s Vice President for Statistical Research and Consultancy, Jennifer Rogers, takes a look at the latest COVID-19 numbers in more detail and explores the possible impact of vaccinations.
On 21st October, the daily reported number of new COVID-19 cases was 52,009 with the daily reported number of new cases being consistently over 40,000 for the 9 days previous. The last time cases were consistently over 40,000 for this many days in a row was back in January as we were coming out of the last winter wave. The UK Health Secretary, Sajid Javid, has also said that COVID-19 cases could hit a record 100,000 a day. Now, I tend to view these kinds of statements with a sensible amount of scepticism, but there certainly seems to be a suggestion that COVID-19 cases may be on the rise.
There are multiple difficulties seen in data integration (ISS/ISE), especially with the quality of data input into the integration. Quality should/must be everyone’s responsibility at all levels. After all, a study is only as good as its data and the practices used to interpret that data. As programmers, we have a unique role in this process as we often review the study data at a detailed level over the course of a study, review and approve data input specifications for completeness, and work with the study team to consolidate and the clean data in preparation for analysis. With some proper processes and planning, we can work to resolve data issues and questions early lest they result in rework later in the programming process.
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