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Joining Imperial Clinical Trials Unit – one year on…

In early 2021, Leila Janani and Graham Wheeler joined the Statistics Team at Imperial Clinical Trials Unit (ICTU). In this post, they look back on starting new jobs during the COVID-19 pandemic and what they’ve been working on over the last 12 months.


Leila

I started my role as a Research Fellow (Clinical Trials Statistician) at ICTU in January 2021. I am originally from Iran, and I arrived in the UK during the third lockdown and experienced difficulties settling down and starting my work on projects.


My first weeks were spent on induction courses, regular meetings with my manager and being introduced to the TREAT trial, my main project at ICTU. TREAT is a non-inferiority trial using a Bayesian framework. In early March, we conducted a two-day Elicitation workshop using the Sheffield Elicitation Framework (SHELF) with eight clinicians to understand their prior opinions on the main parameters of the Bayesian model. I helped prepare the Prior Elicitation Plan, Training Document, and the Evidence Dossiers and was a facilitator during the workshop. It was a really great experience.


In March, I also started working on the COVBOOST trial, which was my first experience of working in vaccine trials. COVBOOST is a multicentre, randomised, controlled trial of booster vaccinations against COVID-19. It is the fastest trial I have been involved in with a big statistical team from Oxford, NHS and ICTU. We prepared regular reports to the Joint Committee on Vaccination and Immunisation (JCVI), Vaccine Taskforce (VTF) and MHRA, which needed timely information regarding the safety profile and immunity of different booster vaccinations. We worked to very tight deadlines and even out of normal working hours during the last 6 months. Our hard work paid off, and the first report of COVBOOST was published in The Lancet on 2nd December 2021 (with me as joint-first author!), and the finding of the study made the headlines of many news agencies, including BBC, The Guardian, The Times, and Reuters.


During my career at ICTU, I joined the NIHR Improving Statistical Literacy working group. I am also lead organiser for the monthly ICTU Statistics Team’s Journal Club, which provides an excellent opportunity to discuss new statistical methods and challenges through the team. I also had an advisory role for two fellowship projects and have worked on three new grant applications. Currently, I am working on COVBOOST sub-studies, TREAT, ASC-DSS and COSI trials, and I will be pursuing my methods research on using adaptive analysis for late-phase randomised controlled trials in intensive care with mortality outcomes.


One of the things I really love about the ICTU Statistics Team is having regular self-learning courses, research away days and our newly established writing away days, which are very useful for self-development. The ICTU workspace is very friendly and supportive, and I am really enjoying working here. I celebrated my first birthday at ICTU in December, and it was a memorable moment as my colleagues had a surprise virtual party for me.


This year our team will grow, and new statisticians will join us during the next three months, and we will hopefully experience many more fantastic moments.


Graham

Even in the best of times, the first day starting a new job is often both daunting and exciting. But starting a new job in the middle of a pandemic without meeting people face-to-face, organising your desk, or knowing where the best place to get a coffee is, what should you expect?


In March 2021, I started my current role as Deputy Head of Statistics and Senior Lecturer at Imperial Clinical Trials Unit (ICTU). My first weeks were filled with virtual meet-and-greets, online training, and – as anyone working in a clinical trials unit will know – reading lots of Standard Operating Procedures from home. Yet amongst the remote introductory obligations, I was diving straight into trial work, teaching, and research.


Within the first few weeks, I was sitting on various ICTU committees, chairing our internal Senior Statisticians group meetings and activities, and developing funding proposals with colleagues across the College. Through summer, I was working on and presenting my research in early phase trial designs at the ICTU Stats’ Research Away Day and supervising a Master’s in Public Health student’s summer project on targeted therapies in cancer trials.


In Term 1 of the 2021/22 year, I co-led the Introduction to Statistical Thinking and Data Analysis course on the Master’s in Public Health and MSc Epidemiology degrees. I also taught on ICTU’s brand-new Introduction to Contemporary Clinical Trials course for Imperial clinicians and delivered a seminar on interpreting COVID-19 clinical trial results to the UK Government’s Therapeutics and Antivirals Taskforce. In December, a study of a needle-free vaccine for COVID-19 and future coronaviruses that I and fellow ICTU Statistician Matyas Szigeti are advising on opened to recruitment and was reported by the BBC.


Following a Christmas break, it’s been full steam-ahead with exam marking, hiring new team members, and seeing our guidance paper on developing analysis plans for early-phase trials – written by clinical trialists and statisticians in academia, industry and regulation from the UK and USA – published in the BMJ.


However, a highlight of mine throughout has been meeting and learning from an enthusiastic and sociable team of statisticians, all with their own specialisms and strengths. ICTU is a great place to work and I feel very much at home, even when I’m in the office. The only thing left to work out; which café does the best cappuccino?

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