This blog post is part of a series of posts giving an insight into the role of statisticians working on trials within the Imperial Clinical Trials Unit (ICTU) and how we can incorporate methods work into trials. To view the other posts in the series you can navigate here.
Before joining ICTU
I am originally from Iran, and before joining ICTU, I worked as an Assistant/Associate Professor at the Iran University of Medical Sciences, where I taught Research Methods, Basic and Advanced Biostatistics, Statistical Methods in Epidemiology and undertook research in different medical areas. I was also a member of the Clinical Trial Centre (CTC)/Tehran University of Medical Sciences and head of the Biostatistics Unit and served as a lecturer of good clinical practice and statistical methods in clinical trials. I spent several years as a monitor of clinical trials for national pharmaceutical companies.
However, as someone who’s been really interested in working on clinical trials, I had been looking for a role in this area in a multi-disciplinary environment which allowed for international collaborations. So, I was delighted when I secured my role as a Research Fellow at Imperial Clinical Trials Unit; and I arrived in the UK in January 2021 in the midst of the UK lockdown to navigate London and my new role for the first time.
Starting my role at ICTU
I joined ICTU to work on the TREAT trial, Treating Severe Paediatric Asthma; A Randomised Controlled Trial of Mepolizumab and Omalizumab, and undertake methodological work on Critical Care Trials. However, in early March, my manager, Dr Victoria Cornelius, told me about the idea of a vaccine trial and asked my willingness to be involved working closely with vaccine methodology experts at Oxford University. I had not worked on vaccine trials before, so it was initially a bit daunting 😊; however, I thought it would be a great experience. So, I became involved in the COV-Boost trial in March 2021 when the protocol was starting to be developed.
My role in the COV-Boost trial
This is the largest statistical team I have worked with on one trial. Four statisticians were initially involved, and a further three statisticians have joined us. Dr Victoria Cornelius, Dr Xinxue Liu (Oxford university) and I work closely and are involved in design, randomisation, analysis and reporting. Prof Nick Andrews (Public Health England) provided advice on design and analysis. Dr Elaine Shuo Feng, Annie Wright, Melanie Greenland and Kiarash Tanhahave joined the statistics team as the trial has expanded into multiple sub-studies and we work together on the design, conduct and analysis.
Managing individual roles when you are working across a multi-organisational team is very important. For each step of the trial, the stats team has tried to provide clear role assignments and ensure that results and reports will be available in a timely fashion for regulatory and funding bodies. Victoria was the only unblinded statistician from the beginning of the study. Xinxue and I had a blinded role until the request by government expert committees to conduct an interim look at the Immunogenicity results.
COV-Boost is the fastest trial I have been involved in with protocol writing starting in March 2021, the first participant enrolled on 1st June 2021 and recruitment of all 2883 participants was finished by 30th June 2021, just 29 days later (what quick and amazing work!)
A large team was needed to design, organise, and deliver this trial. Two operational teams from Southampton University and Oxford University along with PHARMEXCEL (an external Contract Research Organisation) did a great job with managing 18 sites across the UK and recruiting 2883 participants within one month.
Obviously, confidentiality is an essential part of all trials; this was particularly important for COV-Boost due to increased attention from the media and public. I had to remain vigilant and refrain from discussing any details of my work, even with my closest friends and family.
Vaccine trials typically have a diverse set of outcomes, including several immunogenicity markers and analysis of adverse events is a primary focus. I had to quickly familiarise myself with methods for working with laboratory data and adverse events analysis having not worked on a vaccine trial before.
Final word
It has been a great experience being involved in the COV-Boost trial. For me, this trial is a symbol of great teamwork and fantastic collaboration between different parties and institutes. I have learnt a lot about working with different lab and adverse events data as well as analysing and reporting immunogenicity outcomes. Working on a study that has had a significant impact on our people's health is a wonderful feeling. I would like to say a big thank you to the whole trial team and participants who consented to participate in our study.
I should also mention that this trial is ongoing and follows participants until 242 days post-vaccination, and as of December 2022 the day 242 paper is being written up for publication.
We also have a few ongoing sub-studies within this trial, including:
Control-Group Sub Study: Evaluation of “late boost” 7-9 months after the 2nd dose.
Fourth Dose Booster Sub-Study
Variant Specific Fourth Dose Booster (Stage 2)
External Sub-Study: Novavax
Young Adult Fractional Dosing Sub-Stud
And I am looking forward to working on newly available data and publishing new reports! 😊
Leila Janani
Acknowledgements:
As mentioned in this blog series the running of this trial wouldn’t be possible without having such a collaborative group. We would like to acknowledge the roles of others in the team: Professor Saul Faust (chief investigator), Dr Alasdair Munro, our sponsor (University Hospital Southampton NHS Foundation Trust), our funders (NIHR, the Vaccine Task Force and DHSC and CEPI), The Oxford Vaccine Group, the external contract research organisation (PHARMExcel) and the COV-Boost Study Group.