The personal experience of a clinical trial patient
I have been working in clinical research for over ten years. I was originally based in a Phase I Clinical Trials Unit but later moved to the NHS. After working in a number of clinical roles with patients, I now work in GCP Quality Assurance. It is my job to check that clinical trials are completed to the highest ethical standards, and that regulatory requirements are met at all times. After working on numerous clinical trials across multiple disease areas and throughout different clinical phases, I always wondered if put in the situation, I would agree to be a clinical trial patient. I didn’t expect that I would be faced with this situation so soon.
In 2007, at the age of 27, I started having a number of health issues, particularly with my skin. In 2010, the problems worsened as my nails started to turn brown, and pits started forming. When I visited my GP, I was told it was just a fungal infection and would clear with tablets. I had taken the tablets for over a year with no change. In fact, the ‘fungal skin and nail infection’ only got worse. I ended up visiting a new GP who requested laboratory sampling. On receipt of a negative result for infection, my GP suggested it may be psoriasis (I didn’t realise psoriasis affected the nails). At the time, I was undertaking my Masters degree in clinical research part-time while working a full-time job. I was even doing a research project to examine ‘pharmacovigilance’ – the identification and assessment of adverse reactions to medicines.
During this stressful period, something very strange happened: two of my toes and the little finger on my right hand swelled up. I also experienced pain in my feet, fatigue, and exhaustion, which would not go away – even after sleeping or rest. It became so bad that I often slept all day on weekends and I also started taking more sick days at work. The psoriasis on my toenails became particularly bad on my feet. I googled “swollen toes psoriasis”- and “psoriatic arthritis” (PsA) came up instantly. The tiredness, pain in my feet/ankles, and skin finally made sense. I returned to my GP who immediately referred me to the hospital where I was diagnosed with PsA. I was placed on methotrexate (the standard treatment) and after several months of nausea, headaches, and general malaise, I decided it wasn’t for me. The side effects were not worth the tiny amount of benefit I was seeing. I felt this was ironic considering my recent project looking at the side effects of various medications. I discontinued use of the drug and decided to go without treatment – this is when the symptoms of PsA slowly started to return.
It was at this point I was told about a clinical trial for a new biologic drug. As a phase III trial, I understood that it already had a lot of safety information in place from previous trials. Regardless, I was still nervous about potential side effects, but decided it was worth a try. It was the best decision I have ever made. I started the trial in September 2013. There are a lot of procedures involved, from questionnaires to joint and skin assessments – when compared to standard care. But it is all worth it as the trial medication has changed everything for me. As a placebo controlled trial for the first 24 weeks, I didn’t know what treatment I would be on; however, as my skin cleared after only two weeks of injections, I could easily guess. Since then, my joint and back pain has almost completely cleared. My skin is clear and my nails have all grown back normally. The trial is for five years, so at least I can remain on the drug for most of my 30s. I’m so grateful that I was afforded the opportunity to be a clinical trial patient. I always knew how important it is for patients to participate in research but I didn’t realize how beneficial it could be. I am now able to live a happier life; life is good.
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