Empowerment through experimentation: what I learnt as a clinical trial participant

Believe it or not, I actually enrolled on a clinical trial when I didn’t even know much about them. I was studying Biomedical Science at University at the time and was contacted by an allergy nurse at Addenbrooke’s Hospital about a peanut allergy trial.

Having grown up with a severe peanut allergy, the sheer thought of consuming any amount of peanut was enough to make me feel sick. For?nearly 30?years I have lived with the worry of going to restaurants, eating at other people’s houses, or having an awful experience on a plane. But the feeling of knowing my ‘limit’ and helping others in the future by participating in a trial was enough to pique my interest, so I?got in touch with?the nurse.?

After screening and consent, I enrolled onto the TRACE peanut allergy study which was aiming to find out the threshold of peanut that posed a risk to those allergic?in order to?improve food labelling. The study comprised a baseline challenge and then three interventional challenges (exercise, sleep deprivation, and no intervention) so the study was not too intensive. It involved a peanut challenge where I was given increasing amounts of peanut flour (in a chocolate spread) to eat, until I developed an allergic reaction, which was then treated. The data showed that exercise and sleep deprivation or stress significantly reduces the amount of peanut required to cause an allergic reaction 1 .

However,?it’s?not the trial data I want to go into detail about. Reflecting on my experience of being a participant on this trial, as someone who now works in the industry, there a few areas that I believe made my experience a good one and that we could all take on board.

#1 Knowledge is power

We need to realise that everyone has differing levels of knowledge about their condition as well as individual motivators when it comes to learning about our own medical conditions. Some people prefer to only know what they need to, whilst some prefer to have all the options presented in as much detail as possible. As someone from a science/healthcare background, I would say I was interested in the trial on a deeper level. I wanted to know how the trial was designed, what the tests were for and why I had to wait a while to eat after being exposed to peanut. I was able to ask as many questions as I wanted during and in-between visits and was never met with any negativity, just a desire to answer my questions. This meant I was kept informed and felt dedicated to the trial, which motivated me to attend?all of?my scheduled visits and engage with the purpose and mission of the trial.

My learning from this is that we must make participants feel comfortable and empowered to ask the questions they need to gain the understanding they desire.?

#2 Empathy and understanding

Despite being a fit young adult, I have never felt so vulnerable as I did during the study challenges. I was putting my trust in those around me, some?doctors?and nurses I hadn’t seen since I was a child, and it was extremely nerve-wracking for not only?me?but also my mum who was present at my visits. After all, she is the one who sat me on her lap and drove me to the GP when I was 18 months old after having my first (and only) anaphylactic shock (I had some persuading to do when I first mentioned to her that I was considering taking part in the trial). She was obviously apprehensive about the whole thing and wanted to know why I wanted to do it. Over the years my mum has often blamed herself for my peanut allergy – the advice has changed so much...avoid peanuts when you’re pregnant, don’t avoid peanuts and so on.??The way in which the healthcare team approached this sensitive topic with my mum was amazing. They explained why the advice had changed so much and confirmed that current evidence does not support women avoiding peanuts in pregnancy to prevent peanut allergy.?I think it?was the first time my mum ever listened when someone told her it?wasn’t?her fault.

A reminder that we must treat a patient’s loved ones with the same amount of empathy as we give to them. The impact of any condition on a family can’t be forgotten.?

#3 Communication

During the trial I formed great relationships with my healthcare team, particularly the research nurses and doctors that made me feel like an important and valued part of their research. They communicated clearly over email and phone to remind me about when my appointments were, as well as preparing me for what was going to happen at each visit. I had to fast before my?visits?so I quite appreciated the reminder! The team were open and honest and extremely transparent.?

The scariest thing for me (and my mum) was when a reaction started after consuming peanut. Although the trial was placebo controlled, I immediately knew when I had consumed peanut. Going against my usual reflexes I knew I needed to stay calm and tell the team exactly what I was feeling. Quite a few of the symptoms were ones I?hadn’t?experienced before (like stomach cramps) after being so careful all my life and only having ever experienced mild reactions. Despite knowing how quickly things could change, the team remained calm, talked me through what was happening, checked on all my symptoms and told me what medicines they were giving me to calm the reaction down. They stopped the challenge before symptoms escalated and kept a close eye on me. Over time, these experiences became something I didn’t feel scared of – I learnt I was in safe hands and the team would tell me if anything changed that would put me in danger.

Communication is a powerful tool – we can and should use our words to put participants’ minds at ease and keep them informed through their trial experiences.

My hope for the future?

Despite allergies being on the rise, research in this area is underfunded and we have a long way to go before it is ‘safe’ for people to live a normal life with allergies.?

In the past few years, my experiences have got worse. Many of us now have to sign waivers in restaurants, awkwardly leave 5 minutes after entering a restaurant when they tell you they can’t make anything ‘safe’ for you or, even worse, get threatened to be chucked off the plane despite my dad once offering to purchase all the peanuts on board the flight (true story!). Any allergy?is?a constant and scary thing to live with and more research is necessary to find treatments.

I didn’t go into the trial expecting it to change my life, but I am so glad I did it as it may help others in the future and let researchers understand more about peanut allergies.?

Taking part also sparked my interest in clinical trials, and ultimately brought my career to where it is today. I think everyone in this industry needs to stand in the shoes of those in research. Whether that be volunteering on a?trial, or?working within the healthcare environment and understanding the pressure sites face in their day-to-day roles – the more we understand, the more we can empathise and create effective solutions that meet the needs of everyone involved in the trial.

Angelina Radjenovic is a Strategy Director at Faze , a specialist patient recruitment company.

References

1 Food Standards Agency. The effect of sleep deprivation and exercise on reaction threshold in peanut-allergic adults: a randomised controlled study. Available at:?https://www.food.gov.uk/sites/default/files/media/document/the-effect-of-sleep-deprivation-and-exercise-on-reaction-threshold-in-peanut-allergic-adults-a-randomised-controlled-study.pdf . Accessed August 2023.