My experience as a Project Manager of the Oxford/ AstraZeneca Covid-19 Vaccine Trial

My Experience as a Project Manager of the Oxford/ AstraZeneca COVID-19 Vaccine Trial

BY UZMA KHAN

Choosing Research as a Career: The Holy Qur’an states:

“You are the best people raised for the good of mankind; you enjoin good and forbid evil and believe in Allah.” (3:111) In this verse, Muslims have been instructed by Allah the Almighty to serve mankind and promote goodness. If they fail to achieve this, then they cannot state that they are the “best people”. Thereby, Islam teaches that Muslims must always be ready to serve mankind and have love and kindness for all of Allah’s creation. One form of abiding by this verse and serving humanity is by working in the field of research. Hazuraba in his Friday Sermon on the essence of the Waqf-e-Nau also encouraged us to work and excel in the field of research: “….I will advise the students that they should go into research in different disciplines of science as well. And in this, generally, both Waqfeene Nau and other students are included. If, in various departments of science, our best scientists are produced, then, in future, whereas the Ahmadis will give the religious education and the world will depend on us to learn about the faith; there will be Ahmadis who will be imparting the secular knowledge as well.” (Friday Sermon – the Essence of a Waqfe Nau 28th October 2016) I embarked on my journey of becoming a Project Manager by graduating with a First-Class Honours Bachelors in Physiology and Pharmacology from the University of Westminster.

Subsequently, I completed my post-graduation masters in Preventative Cardiology from Imperial College London. During my final BSc year, I lost my father due to a sudden heart attack. I routinely wrote to Hazuraba to request special prayers for me to cope with the loss of my father and also continue to stay focused and committed in my education. Although I faced a very personal hardship in my life by losing my father during my BSc time, I can confidently say that solely due to the result of Hazur’saba dua for me as a Waqf, my achievements were remarkable enough to enlist me into the Dean’s list of high achievers. Following this, I also qualified to receive the Academic Award at Jalsa Salana 2015 and 2017 for my BSc and MSc qualifications respectively from Hazuraba. Subsequently, the decision to undertake a postgraduate degree as per Hazur’saba guidance also resulted in me being able to work in a vast variety of research fields and eventually lead to working as a Project Manager in Infectious and Immunity diseases a year prior to the pandemic.

Normal Trial vs COVID-19 Trial Under normal circumstances, a clinical trial set up can take up to 3-5 months. This primarily depends on the nature and complexity of the trial and the arrangements that are required to be made prior to initiating the trial. Among many factors, some may be:

Factors

Brief explanation

Applications to regulatory authorities are submitted, laying out purpose of trial and the design that will be followed

Approval must be granted prior to initiating the study at any participating site

Contractual agreements - Financial agreements - Milestone agreements

The more selected sites there are in a study, the longer it may take to set up the contractual agreements due to local policies/differences

Pre-site selection visit

Completed to assess the site facilities at which research activities will take place

Consumable/equipment orders

The more experienced a site is, the fewer equipment related orders may be needed.

However, consumables will be required as they are study specific

Laboratory arrangements

For study designs that require laboratory sample processing.

N/A to data collection survey etc.

Study specific training and site initiation visit

To complete paperwork relative to the study and sign off all documents that reflect study specific training has been completed

The above-mentioned activities are a basic checklist which were all expedited in the light of the urgency that the pandemic presented itself in terms of the high prevalence and mortality figures. Initially, as the regulations and guidelines took a while to establish, quite a few of our trials were still on-going whereby we conducted home-visits to facilitate our paediatric participants – this we could foresee to change in the near future. Just before the Oxford Vaccine Group approached our team to take part in the COVID-19 vaccine development trial, most of the other studies were put on hold as they did not classify as an urgent public health study anymore and presented a higher risk of staff and volunteers being subjected to the COVID-19 virus.

As part of the Infection and Immunity research institute, our team had an established infrastructure and facilities required to conduct such a fast paced and challenging study. We were an experienced team of chief/ principal investigators, clinical research fellows, research nurses, research midwives and project managers, but nobody had worked under the influence of a pandemic previously. This meant that everyone’s input in this trial from the setup to recruitment and ongoing follow up phase required an extra effort and sacrifice in time and energy. Thereby, the mental and physical adaptation to working in the pandemic environment and successfully manage this trial was not an unfamiliar situation for me but there was an additional pressure of being labelled as a ‘critical worker’ which increased with time as the numbers of deaths across the globe increased.

Moreover, the preparation, conduction and administration of this trial were very different to the previous trials I had been involved in. We were required to adapt to ever changing and newly emerging information and then subsequently undertake training in a short amount of time in order to be ready to implement the new change. Furthermore, our site recruited more than 400 participants into the trial and as the project manager of the study, I was required to continuously sustain a line of communication with our participants and keep them informed about the developing changes in the trial. I remember writing to Hazuraba on a monthly basis to request for his prayers in the success of our trial and development of a vaccine that could help the thousands of people who were suffering from the COVID-19 virus.

As the project manager of this trial, I was responsible for ensuring that the current study procedures were being followed, within the allocated budget and in compliance with the regulatory requirements. Additionally:

• Coordinating and managing the collection of research follow-up data according to the trial protocol • Ensuring data is collected on time and study visits were being held on time • Communicating with trial participants • Completing trial monitoring procedures • Keeping the investigator site file up to date with current documents and any new amendments that were received • Ensuring new team members were appropriately trained prior to working on the trial; it was mandatory to hold a good clinical practice certificate and be familiar with study standard operating procedures Prior to the pandemic, I was managing 6-8 trials at the same time but the major difference this time around was the complexity and scale of the COVID-19 vaccine development trial which required an extraordinary amount of effort and commitment. I certainly feel that my training and experience of serving in the Jama’at presented itself as a blessing in disguise. Having served in the national General Secretary team and having volunteered in MTA on a regular basis for 12 years, provided me the basis of self-discipline, steadfastness and resilience to working under pressure which were all skills that I could transfer into this job.

Release of Oxford/AstraZeneca COVID-19 Vaccine Each and every visit that a participant completed for the trial, provided us with invaluable data for the success of the vaccine. During the recruitment and follow up phase of the trial, one of the many continuous tasks that we completed were data cleaning and answering queries. As with any clinical study, the primary focuses of the trial were a) to ensure participant safety and b) to ensure that the data is collected in an unbiased way and stored securely. The more follow up visits that were completed by participants (across all sites), the closer we were reaching to the point of being able to complete an interim data analysis and see preliminary results of the vaccine. This would allow the statistical data management team to measure variables of interest

in an established methodical fashion that answered predetermined research questions, test the study hypotheses and evaluate outcomes of safety and efficacy of the trial vaccine. As the study design of the trial was a randomised controlled trial, we were blinded to the type of vaccine given to a participant (either ChAdOx1 nCOV-19; study vaccine or MenACWY; control vaccine. Thereby, for us, it was imperative to ensure all the data was accurately measured and collected as either way it would contribute to the results of the study.

The process of data cleaning involved contacting participants occasionally to ensure that any ambiguity on participant history were ironed out. Additionally, participants were continuously reminded to report any unexpected symptoms to an on-call doctor so that those could also be recorded and assessed appropriately. These activities took a serious turn when we were given a data cleaning deadline by the Oxford team to ensure that all the data could be submitted to the regulatory bodies on a designated date to assess the safety and efficacy of the vaccine. This was jointly actioned by the entire team just before the winter break.

Alhamdolillah, the work that commenced in March 2020 finally provided its initial results in December 2020. On 30th December 2020, University of Oxford was able to publish the news that the UK government had accepted the recommendation from the Medicines and Healthcare Regulatory Agency to authorise the emergency use of ChAdOx1 nCOV-19 vaccine in the United Kingdom. Once the vaccine was approved, AstraZeneca worked in collaboration with Oxford University to globally manufacture and distribute the vaccine across the globe. At this point and throughout the trial period, I have been continuously very grateful to Allah the Almighty for giving me this incredible opportunity. As for everyone, this has also been one of my unthinkable experiences of living in a lockdown; further strengthening my realisation that this world is fully under the control of our Creator.

Under His Divine law of nature, one virus brought the entire world to a standstill and even motivated us to develop innovative ways to stay connected within the Jama’at. Being able to work on reverting this ‘new’ normal and preserving the real connected way of living between humans has been a humbling opportunity and as mentioned only been possible by perusing a career recommended by Hazuraba .

I would strongly recommend for any Waqf-e-Nau to embark on a career in this field as it is very rewarding to be able to contribute to developments that help humanity and treat diseases. *For any further information about the progress of the Oxford/AstraZeneca vaccine, please go to: https://covid19vaccinetrial.co.uk