My Research 

I’m a Clinical Research Fellow at Manchester University NHS Foundation Trust (MFT) studying for a PhD on the biology of chronic cough at the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC). I work in Professor Jacky Smith’s research team within the BRC’s Respiratory Theme. Our research aims to improve our understanding of chronic cough. We have a particular focus on the biology underpinning cough in health and disease.  We hope that in the future this will lead to better and earlier diagnosis of this exceedingly troublesome condition, alongside improved treatment options. 

The NIHR Associate PI scheme

Alongside my PhD, I have taken part in the NIHR Associate Principal Investigator scheme. This scheme is an opportunity for hands-on experience of delivering a study and is designed for people who do not normally take part in clinical research in their day-to-day roles or have recently transitioned into a research role (such as a PhD or early career research fellow).  

Working with a principal investigator (PI) over 6 months, individuals learn about study set-up, management, and training. They have access to an online platform, with links to NIHR training videos and Good Clinical Practice courses, which provide a framework for good research practice. 

Why I did the course

This course provided a formal framework to assess and evidence my knowledge of clinical trial delivery. The course structure and online platform allowed for flexible learning. The scheme also tied in neatly with transitioning from an NHS role to delivering research during a PhD.   

My experiences of the scheme

During the scheme I have acted as an associate PI on an observational study called StARR, which is looking at symptoms experienced in patients with chronic cough. With PI Dr Paul Marsden, Consultant in Respiratory Medicine who leads the Manchester Chronic Cough Service at MFT, we are evaluating a novel questionnaire assessing triggers and sensations which provoke cough to find out how these relate to other measures of chronic cough severity and impact. We also aim to see how these sensations and triggers change over the course of assessment and treatment. This is a real-world study of patients referred to NHS cough clinics at Wythenshawe Hospital, part of Manchester University NHS Foundation Trust, and Royal Preston Hospital, part of Lancashire Teaching Hospitals NHS Foundation Trust. 

The NIHR Learning Platform is user friendly and provides clear instructions outlining the Associate PI scheme journey and learning outcomes. A monthly learning blog is provided with suggestions on study-related activities. Additional online lectures are available on a range of subject areas related to research governance, ethics, and study delivery.

My supervisor, Paul Marsden, and I incorporated the scheme checklist and materials into weekly and fortnightly PhD supervisor meetings.  For NHS colleagues, meeting with the study PI can be flexible and arranged around clinical commitments over the course of 6 months. The platform allows PIs to signpost the Associate PI to specific training on the online platform, for example there is section on managing and documenting adverse reactions during a study.  

Not only have I enjoyed participating in the scheme, but it has also given me a greater understanding of the role of the PI, research frameworks and study delivery. Professionally, the scheme has provided opportunities for training, collaboration, and personal development. This leaves me well equipped for further my research career within the Manchester BRC. 

Professor Georgina Moulton, Academic Career Development Lead at Manchester BRC said: “At Manchester BRC, the NIHR Associate PI Scheme helps to build local capacity to run and manage clinical trials. Our next steps are to expand the reach of this scheme across Manchester BRC trials and build an annual local cohort of Associate PIs with knowledge and skills to drive our work forward.”

If you would like to find out more, please contact: georgina.moulton@manchester.ac.uk 

My first experience of national research began in 2016. I had been a Radiographer for 13 years, a sonographer for 8 years. This year I celebrated 20 years' service with the University Hospitals of Leicester

In 2016 had spent 2 years specialising in head & neck US and US guided procedures. An opportunity had risen for our site to take part in the ElaTION Trial, run by the Birmingham clinicals trial unit. Initially I presumed my role was to screen for eligible patients during my lists and perform the US / fine needle aspiration (my day-to-day role). 

After difficulty in finding funding for a research nurse my mentor and PI, a head & neck Consultant Radiologist Dr Ram and myself took on the challenge alone.

This was a huge learning curve for me, with no 'real research' experience I was guided by Dr Ram (PI) to complete the NIHR Good Clinical Practice E-learning and complete the necessary elastography accreditation (elastography is an adjunct to greyscale US that checks tissue stiffness, the trial was investigating its use on thyroid nodules in the attempt to reduce the need for further treatment).

To cut a long story short, I supported the PI in every part of the study from completing screening logs, checking eligibility, consenting patients, randomisation, informing GPs, performing the treatment allocation ( US/Fine needle aspiration/elastography), organising & posting blood samples, arranging follow ups (3 month/6month/12month, completing the patient assessments and posting them back to the Trial unit (HADS/CRF) ETC. 

Although I had completed the necessary training and I was fully supported by the PI and trail unit, I was on the job training!! Can you imagine the imposter syndrome 🤣. We recruited 30 patients and were one of the highest recruiting sites.  I was immensely proud of myself and had learnt so much. 

After the trial, I continued with multiple service improvement projects and felt so much more confidence in being involved in audit and research. I completed the SOR Advanced Practice accreditation finally being able to evidence the research pillar appropriately (usually to most difficult pillar, even in AP roles).

I am now Associate PI on a new National trial (HoT) - I now understand the protocol so much better and can really enjoy the process.

However, it was not until I attended the NIHR Research, the NHS and you A joint NIHR and NHS Conference (21/9/23) that I learnt about the Associate PI scheme!

I have now joined the scheme and will evidence my journey retrospectively and prospectively for the next 6 months to receive a certificate that will finally evidence what I have achieved officially.

The application form was very simple and straight forwards, the research project has already started but as long as there is 6 months left you can still enrol. All I needed really was a signature from the PI (Dr Ram again!)

I feel that all too often as radiographers we extend our practice without really knowing what we are achieving, often new practices, knowledge and skills are learnt in-house and there isn't always a course, programme, HEI associated credit to reflect our achievements, my career is definitely reflected this way, i have been lucky to have found ways to evidence my practice and reached Consultant level role in 2022, but it wasn't easy.

I am so glad to have found this scheme for my own career but I will endeavour to spread the word far and wide to make sure others are aware of it too.

Amy Barnes 

Consultant Radiographer

When Covid-19 first hit the UK I was working as a junior doctor in ICU. I met a patient who was being prepared for intubation by the anaesthetics team. I introduced myself, and explained I would be helping to look after them whilst they were asleep. They said they were afraid and uncertain whether they would see their family again. I realised how little we knew about this virus and therefore how little hope we could offer to anyone in this position.

This scenario played out many times up and down the country before things got better through crucial research.

Through hard work a picture emerged of what this disease was and I remember with palpable relief in June the news that the Recovery trial had found a treatment that works in dexamethasone. Little did I know that just over half a year later I would be contributing to the Recovery trial as an Associate Principal Investigator.

Junior clinicians often put research on a pedestal, as something for later in their careers, to be aimed for when they have the means and the seniority. When the PI at my site invited me to take part in both Covid research, and encouraged me to undertake the Associate PI scheme I realised that there is a role for everyone in research - junior or senior.

Starting with no research experience I was impressed with the processes that ensure research is done safely and to a high standard. Initially the Associate PI checklist and strong support from an entire Research Team allowed me to grow in confidence. As well as trial recruitment I was encouraged to become a team leader who knows the trial and team inside out. Ultimately, this allowed me to help shape the progress of Recovery at my site. 

I gained a global view of how a clinical trial works, from management of staff, to the development of approaches as new therapies became available, to sharing the message with the wider hospital teams to encourage participation. I feel like I got a true understanding of what research could be like as a part of my career.

So much has changed since last year when there were no proven treatments. I know now that when I go to discuss the Recovery trial with a patient I can say for certain to them that they are already getting excellent and well evidenced therapies, but I also know that through the trial I am offering to them I may be able help them receive the most up to date novel approaches to this illness that we have available.

At the completion of the scheme and upon receiving the certificate that confirmed my status as an Associate PI, I felt an immense sense of pride. Not just for being a contributor to an excellent example of how a trial can directly influence patients outcomes, but for also getting to know and help many patients who even while they were extremely unwell were happy and enthusiastic to help others by being participants. 

I’m endlessly grateful to my PI who suggested I undertake the scheme, it didn’t feel like the traditional consultant/junior relationship, we became equal partners in the running of the trial at the site and his mentorship was much appreciated.

Research might have been something that I thought wasn’t accessible for me at this point of my career, but the Associate PI scheme has not only allowed me to break into research, it has given me a great footing to continue being involved and build research into a significant part of my future career.

Samuel Hey, 

Junior Clinical Fellow - Infectious Diseases
X - @HeySamuelHey

It is said that opportunities multiply as they are seized; my time as an Associate Principal Investigator (API) for the Sunflower Study makes this statement ring true.

First off, what is the API scheme?

It’s a programme operated by the National Institute of Health Research (NIHR) which aims to develop future Principal Investigators (PI) by providing mentorship and guidance to health professionals (junior doctors, nurses, midwives etc) to deliver accredited studies to time and target.

The scheme is endorsed by the various Royal colleges and aims to provide formal recognition for contributing to the delivery of NIHR Portfolio research studies.

There are over 150 approved studies spanning a wide range of specialties trying to answer diverse research questions.

How does it work?

Identify an eligible study you are interested in; in my case I was already a member of the Sunflower which was eligible for the API scheme, hence a natural fit for me.

The next thing to factor is the fact that the scheme requires a commitment of at least six months for certification; hence it is necessary to look at how long you would be in that particular hospital or region.

There can only be one Associate PI for one study per hospital at a time hence showing interest early is key.

The next step is then to register to be an Associate PI for the study of your choice after discussing with the Principal Investigator (PI) for the study.

In my experience, I got a lot of support from my PI and the study Clinical Trials Unit for my application and in carrying out my necessary duties.

What are the duties of an API?

Core activities include regular meeting with the PI; in my case I worked on the same unit as my PI so we were able to have regular contact and updates.

Raising awareness of the study is also critical to ensure identification of eligible study participants and enrolment.

I found that most patients were happy to join studies as the importance of research has been highlighted by the covid pandemic.

Other duties involve working closely with the PI to ensure the delegation log is up to date and team members are recruited and duties delegated.

There is a six-month learning course on the website NIHR Learn that essentially serves to document your participation and provide access to a good range of learning materials.

My Experience

As a full-time junior doctor, I never felt overwhelmed by my duties as an Associate PI, my PI was always accessible and served as a great wealth of knowledge. Most of my duties were quite easy and some could be carried out on the go; like sending out emails to the department regarding patient recruitment or discussing with other study participants on how we can drive recruitment.

The scheme gave me a good look at the inner workings of research delivery and gave me a sense of ownership of the study.

The CTU and NIHR staff were also great in responding to queries and helping me navigate the NIHR website.

It's fair to say the six months passed by easily and I never felt pressured or out of my depth while also carrying out my day-to-day clinical activities.

What have I gained from the Associate PI scheme?

I believe some of the more intangible things I have taken from my period as an Associate PI are the most important; the experience of research leadership is parallel to none. Mentorship by a senior PI has mentally prepared me for the role in future and my leadership skills have been greatly enhanced.

More tangibly, the Associate PI certification looks excellent on the CV and Associate PIs are acknowledged in the primary publication(s) generated from the study.

The skills I have gained through the Associate PI scheme are versatile and indispensable and are becoming an essential part of even my clinical practice.

Bankole Oyewole