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.
Written by Professor Jennifer Rogers on . Posted in Blog
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.
PHASTAR was contracted to assist a pharmaceutical company with the conversion of 16 legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies) and with the pooling and reporting activities of their Integrated Summary of Safety (ISS) for a regulatory submission. It has been quite a challenging project but one of the most exciting due to its complexity.
PHASTAR were supplied with legacy datasets of the 16 Phase I/II studies, Raw CRF, protocol and CSRs, alongside ISS SAP and Shells. Before starting on the CDISC conversion, we worked on a thorough due diligence activity, checking each study protocol and the original study data (sent in different files formats). We created the individual SDTM specifications for each study, using their own automation tool for the RAW to SDTM mapping. The automation of SDTM annotated CRFs were also generated before any programming activities started.
PHASTAR's Head of Statistical Research and Consultancy chaired the judging panel for the Royal Statistical Society Statistics of the Year. Here, she goes through the winners and the runners up, highlighting the statistics that sum up 2020.
