Recent reports suggest that there may be a cause for concern with the Oxford AstraZeneca COVID-19 vaccine, with a suggested link between the vaccine and blood clots. Just how worried do we need to be? PHASTAR’s Vice President for Statistical Research and Consultancy, Jennifer Rogers, talks us through what we know.
It’s been almost 9 weeks since Margaret Keenan became the first person in the UK to receive a COVID-19 vaccine as part of a vaccination programme. The UK government had set themselves an ambitious target of offering a vaccine to its top four priority groups in the UK by 15th February. This was the equivalent of 15 million people and on 14th February we learned that this milestone had been reached.
Getting over this first hurdle is one thing, but understanding the impact of the UK vaccination programme is going to be essential in easing lockdown restrictions. PHASTAR’s Vice President for Statistical Research and Consultancy, Jennifer Rogers, is being asked more and more whether vaccines are having an impact on COVID-19 case numbers and deaths. But what does the data show?
Last week certainly was an interesting one for COVID-19 vaccine developments, with the results from two more vaccine studies being announced. Here PHASTAR’s Vice President for Statistical Research and Consultancy, Jennifer Rogers, walks you through the key points.
Let’s start with the Novavax announcement which happened on January 28th. Results from the Phase 3 UK study reported a vaccine efficacy (VE) of 89.3%. This was based on 62 symptomatic COVID-19 cases at the interim analysis, where 56 cases of COVID-19 were observed in the placebo group versus 6 cases in the NVX-CoV2373 group. This study enrolled more than 15,000 participants between 18-84 years of age and included 27% over the age of 65. Those over the age of 65 are at a much higher risk of hospitalisation and death if they catch COVID-19 and so understanding the efficacy of potential vaccines in this age group remains of particular interest. According to the study protocol an effort was made to enrol a target of at least 25% of participants who were at least 65 years of age.
2020 was an unprecedented year in many ways, for everybody around the world. The coronavirus pandemic has seen businesses face disruptions to their usual schedules, changing the way we interact with potential customers, how our staff work and for many, if we can open at all. For PHASTAR, the challenges of 2020 have shown us the true strength of our team and their adaptability, positivity and determination.
2020 saw many highlights for PHASTAR; February saw us open our third US office in San Diego, California, giving us the ability to offer sponsors on the ground, local biometrics experts underpinned by a larger global team. In June, we opened our first office in Tokyo, Japan, bringing our expert led, specialised biometrics services to our growing Asia customer base. This office thrived in 2020 and continues to grow into 2021. Our China office will be opening in 2021 and we look forward to that meeting the same success as Japan.
The crucial role of clinical data management (CDM) in a successful clinical trial is well understood, and central to this is the production of quality, accurate and comprehensive clinical data. This is critical for safety and efficacy to meet the standards to pass review by the regulatory authorities.
Modern techniques for CDM are emerging in the application of data science tools and technologies to support data validation and reporting activities. Indeed, at PHASTAR, our Data Operations group utilises data science techniques by applying novel approaches such as the application of AI and development of visualisations to deliver insights, drive efficiencies and ultimately add value to the clinical trial process.
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