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A CAREER �IN CLINICAL TRIALS

POLLY FOX

POLLY.FOX@IMPERIAL.AC.UK

CLINICAL PROJECT MANAGER, DEPARTMENT OF INFECTIOUS DISEASES, FACULTY OF MEDICINE, IMPERIAL COLLEGE LONDON

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My Background

BSc Medical Sciences, Sept 2014 – July 2017

No professional training year and no specialism.

Dissertation: Searching for novel causes of neonatal diabetes.

After graduation, I worked as a Patient Administrator at a private hospital with a view to going on a healthcare management training course. Unfortunately, they didn’t make good on their promise with this course so I left. Do not stay in a role where you feel you are not valued and they do not care about your career development.

I then went travelling before moving to London and starting the job hunt.

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Research Studies / Clinical Trials

CTIMPs or RCTs

A clinical trial compares two or more treatments (often a new treatment vs control such as an existing treatment or a placebo) in patients with a condition or at risk of a condition or even in healthy volunteers to help generate high quality evidence about which is the more effective treatment.
The treatment being investigated in a clinical trial can be a medicinal product, a procedure, a device or another type of therapeutic intervention.
Clinical trials are essential to evidenced based practice and help guide treatment decisions for both health care professionals and patients. They are also an important part of the pathway by which new medicinal products/devices can obtain a licence from MHRA and become available for clinical use.
A clinical trial should be considered when there is uncertainty as to which treatment option or preventative strategies is more effective.
Once the case for a new clinical trial has been made on medical, ethical and financial grounds then the trial needs to be designed so that it will provide the highest possible quality of evidence to guide future decision making.

Non-CTIMPS or Observational Studies

These are studies which do not involve an “intervention”.
Participants will have samples and/or data collected. These studies are often done to observe the effect of a risk factor, diagnostic test, treatment or other intervention without trying to change who is or isn’t exposed to it.
Sometimes these studies then help us form hypotheses about a new treatment which we can then test in a clinical trial.

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Clinical Trials - Phases

Phase	Number of participants	Main aims of trial	Randomised?
0	Small – often about 10 to 20 people	Testing a low dose of the treatment to check it isn’t harmful.	No
1	Small – often about 20 to 50 people	Finding out about side effects, and what happens to the treatment in the body. All about safety and tolerability. Sometimes this is where dose escalations are tested.	No
2	Medium - tens of people, sometimes over 100	Finding out more about side effects and looking at how well the treatment works. All about safety and tolerability. Sometimes this is where dose escalations are tested.	Sometimes
3	Large - hundreds or thousands of people	Comparing the new treatment to the standard treatment, usually if this trial shows it is effective/efficacious, the treatment will apply for regulatory approval	Usually
4	Medium to large, variable	Finding out more about long term benefits and side effects. This is usually post-licensure of a new treatment.	No

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Clinical Research Site Administrator

Jan 2019 – Sep 2019
Ageing Epidemiology Unit – Charing Cross Hospital, Imperial College London Research | Faculty of Medicine | Imperial College London)
Role: Bookings, data entry, overseeing the clinic etc
I did lots of training with my line manager on the project management of trials – there are lots of regulatory, financial and logistical considerations for running a trial.
Unfortunately, the Alzheimer’s trial was unsuccessful and terminated early so I was likely going to be made redundant (generally clinical research positions are fixed-term contracts and your position is funded by the trial(s) you work on).

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Project Officer

September 2019 – July 2020
Project Officer (interchangeable as Clinical Trial Coordinator) at St George’s University of London working in the St George’s Vaccine Institute and Paediatric Infectious Diseases Research Group (Vaccine Institute - St George's, University of London).
I was given 10 small studies to manage in areas such as vaccines for meningitis and new treatments for RSV and invasive fungal infections.
I was really enjoying this new challenge of managing studies Then the pandemic hit and all our trials were put on hold.
First COVID-19 vaccine trial.

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Project Manager

July 2020 – Dec 2021
Promoted to Project Manager (Clinical Trial Manager) within 8 months of starting there.
I then had responsibility for bigger trials and for ones where we were the sponsor and we were responsible for setting up other sites to run and recruit to the trial.
I worked on 15 COVID-19 vaccine trials at St George’s.
My most important study was the Novavax COVID-19 vaccine trial.

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Novavax �“A Phase 3, Randomised, Observer-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) with Matrix-M1™ Adjuvant in Adult Participants 18-84 Years of Age in the United Kingdom”

CI: Professor Paul Heath
PI: Dr Catherine Cosgrove
St George’s was the lead UK site (33 sites) and the only site with a satellite site.
Largest ever double blind, placebo-controlled vaccine trial undertaken in the UK.
15,203 participants were enrolled across the UK between 29^th September 2020 – 5^th December 2020

Registered Interest	885
People Called	858
Booked for screening	554
Screened (including screen failures)	523
Recruited	458
Booster Doses (Day 21)	455
Crossover Participants	208
Total Vaccines Given	1,329
Withdrawals	55
Symptomatic Participants	136
COVID-19 Positive	36
Amendments	45

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Novavax COVID-19 Vaccine Trial

Dec 2020 – vaccine rollout across UK.
Unblinding our trial participants.
Implementing a crossover study
Ongoing issues regarding the manufacturing of the vaccine meant delays in regulatory approvals compared to the approval timelines of the other vaccines.
Vaccine passports – trial participants �weren’t being recognised as fully �vaccinated by other countries.

From Dec 2020, the first vaccines had been approved for use in the UK. As we had older people in the trial who were being called up for vaccines, we couldn’t ethically withhold vaccines from participants as they may have received placebo in our trial and be unprotected so they would have to be unblinded. We were unblinding people as their age groups were called up for the national vaccination roll out. If they had placebo, they would take up an approved vaccine but remain in the trial for follow up. If they had received Novavax, they were advised that they didn’t need further vaccines and remained in the trial.

Once someone is unblinded, their data is then censored as they can bias the results of the trial by over-reporting/under-reporting symptoms and side-effects etc. To prevent losing all our participants, we implemented a crossover study. They would stay blinded and we would give them two doses of what they didn’t have in the first round. That way they were guaranteed that they had the Novavax vaccine, they just don’t know what order they had it.

There was a rolling submission to the MHRA and other regulatory bodies across the world for enough data to be presented that the vaccines could get emergency use authorisation. However, there was an issue validating the manufacture of the vaccine at the Serum Institute of India meaning the regulators weren’t happy that the vaccine being manufactured was the same quality as the one being trialled. We didn’t get quick approvals like we were hoping.

We also had an issue with vaccine passports – our participants weren’t allowed to travel on an unlicensed vaccine so they were at quite a disadvantage.

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Novavax COVID-19 vaccine Nuvaxovid approved by MHRA - GOV.UK (www.gov.uk)

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine | NEJM

Good news and bad news.

Bad news:

Because of the vaccine passport issue and the ongoing delays in licensing, participants across the UK were dropping out of the trial or trying to obtain approved vaccines against our advice.

We managed to convince UK government to recognise the trial participants as fully vaccinated for domestic pass and for returning to the country without need to test on arrival. Then we had issues getting participants the NHS app pass. Novavax offered to reimburse all trial participants their PCR tests for travel (up to £200 each).

Good news:

The Novavax jab, which is given in two doses, was shown to be 89.3% effective at preventing Covid-19 in participants in its Phase 3 clinical trial in the UK, and around 86% effective at protecting against the new UK variant. The jab's efficacy against the original Covid-19 strain was calculated to be 95.6%.

The vaccine was finally licensed for use by the MHRA on 3^rd February 2022.

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Clinical Project Manager

Jan 2022 – Present
Clinical Project Manager, Department of Infectious Diseases at Imperial College London
Running the COVID-19 Human Challenge Trial, and setting up a new one. Also running a COVID-19 aerosol vaccine trial, and other human challenge trials for RSV and Flu.

https://ukcovidchallenge.com/

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My Advice

Search Jobs | Job Search | Job Vacancies on jobs.ac.uk for university Clinical Trial jobs (search “Clinical Trial” or “Clinical Research”)
Search NHS Jobs - Candidate Homepage for NHS Clinical Trials (same terms)
Search UKTMN Jobs page: https://www.tmn.ac.uk/pages/4-jobs
Before you apply – take the NIHR GCP course online – it is free and MANDATORY. It will show that you have taken the initiative to learn about clinical trials Good Clinical Practice (GCP) | NIHR – scroll down and register for NIHR learn to access the course
Other routes:

Clinical Research Organisation (CRO). These companies (e.g. PPD, IQVIA, ICON) are usually the go-between for recruiting sites (NHS/Universities) and Pharma companies (GSK/Pfizer etc).
Entry level positions include Clinical Research Associates (CRA’s). These are people who help set up the study and train the sites on the study. They then visit the sites throughout the trial to monitor its progress.

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My Advice

Tailor your answers to the job application in your CV and cover letter.
In your application and interview, give examples of your skills. Use the STAR interview method for answering questions.
If you have any “patient-facing” or ”customer/client facing” experience, maybe through volunteer work or a job, speak about this. Participants commitment to trials is so important so you want to make sure they have the best experience possible.
Talk about times where you’ve worked with a multi-disciplinary team.
Prior to interview, find out who is interviewing and search for their studies and publications. Find these on their organisation website and then ask questions about these studies. This shows you’re genuinely interested in what the research is.

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Other Roles:

Clinical Research Practitioner

Take vital signs and bloods from participants (after training), process samples, help with trial coordination

Lab Technicians or Research Associates

Process samples in the labs

Data Clerk / Data Manager

Enter clinical trial data onto eCRF’s/databases, raise queries, clean data, build databases, programming

Clinical Trial Monitor / R&D Facilitator

Generally work in the R&D office of an organisation and monitor trials and check all regulatory, contractual and financial documents are in place.

Consider further studies:

Postgraduate certificate or diploma or a masters in Clinical Trials or other relevant/interesting areas.

https://www.lshtm.ac.uk/study/courses/masters-degrees/clinical-trials-online

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Useful links

A database/registry of clinical trials all over the world: https://clinicaltrials.gov/
Set up and management of trials: https://www.ct-toolkit.ac.uk/routemap/
UK Trial Managers Network: https://www.tmn.ac.uk/

The Guide to Efficient Trial Management: https://hubble-live-assets.s3.amazonaws.com/uktmn/redactor2_assets/files/4/UKTMNG2.web.pdf

Find out about and take part in research studies: https://bepartofresearch.nihr.ac.uk/
Exeter Clinical Trials Unit: https://www.exeter.ac.uk/research/ctu/trialportfolio/

Find out if there are studies you can take part in or if you can get work experience.