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.
If you’ve taken a look at the UK government’s COVID daily update dashboard recently, you may have noticed that the volume of information presented has significantly increased compared to the first wave. This can sometimes feel overwhelming and you may be asking yourself how you can make sense of it all to get a clearer picture of what is going on.
Over the last few weeks, we have been seeing case numbers increase quite dramatically, even though on Boxing Day, 43% of England’s population were living under the toughest restrictions of tier 4 and a further 24.8 million in tier 3, with a subsequent full national lockdown announced on 4th January. Why have case numbers continued to rise and when might we see these numbers come down? According to the World Health Organisation, on average it takes 5-6 days from when someone is infected with coronavirus for symptoms to show, but it can take up to 14 days. There is also a time lag between a person presenting with symptoms and getting a positive test result on a PCR test. Latest estimates from NHS Track and Trace (published 7th January 2021) showed that for Pillar 2 testing (testing in the community), just 19% of test results were received within 24 hours of taking a test and 17% of test results took longer than 72 hours to be returned. For home testing kits, the worst performing of the Pillar 2 testing strategies and where there will also be a delay in a person requesting a test and receiving it, just 3.5% of results were received within 24 hours of the test being taken and 33% were received after more than 72 hours. Given the time taken for symptoms to show and the subsequent time take for a person to receive a positive test result and it be logged in the system, it is unsurprising that the effects of lockdown are not seen for a good amount of time after restrictions are introduced. Today has seen the third consecutive day that COVID-19 cases have been in the 40,000s, compared to a peak of 68, 053 on 8th January, suggesting that we may now be seeing the effects of strict lockdown measures and have seen the end of the knock on effects of families mixing on Christmas Day. Hopefully, by the time you are reading this, case numbers will have continued to decrease.