Switching from paper to patient – taking part in a clinical trial

tracera_logoI make a living reading clinical research papers and am familiar with the big picture of clinical trials – papers published, guidelines amended and practice improved.  Grassroots clinical research – the work of doctors, nurses and patients undertaking a trial – has always seemed like a million miles away to me.

However, I’m hoping to get a new perspective on the nuts and bolts of how clinical research is conducted as my Dad is currently taking part in a huge rheumatoid arthritis trial – the TRACE RA trial.  This study is investigating whether heart drugs – statins – reduce the risk of heart attack and stroke in people with rheumatoid arthritis.

People with rheumatoid arthritis are at higher risk of cardiovascular disease than the general population and are thus are more likely to have a fatal heart attack or stroke.  This increased risk is thought to be due to a higher incidence of atherosclerosis in patients with rheumatoid arthritis – the inflammation that attacks the joints in such people is though to also affect the lining of their blood vessels.

Statins reduce “cardiovascular disease events” and mortality in high risk populations, largely through lowering cholesterol but also possibly through reducing inflammation.  We don’t know whether statins are beneficial in rheumatoid arthritis though, as people with this highly inflammatory condition are usually excluded from statin trials.

The TRACE RA trial is a prospective, 5-year, multicentre, randomised, double blind, placebo-controlled study that will assess the hypothesis that a statin is more effective than a placebo in the primary prevention of cardiovascular events in patients with rheumatoid arthritis.

Up to 4,000 people over the age of 50 who have had rheumatoid arthritis for at least 10 years are being randomised to receive either the statin atorvastatin or placebo daily. The patients in the trial will be followed up for up to 7 years to see if those on the statin are less likely to have a cardiovascular event than those on the placebo.

My Dad joined the trial quite recently and is currently going through his initial follow-up visits, which take place at 3, 6 and 12 months. At each visit he gives a blood sample and also fills in a questionnaire, which he showed me last time I visited. Dad was a bit concerned about the questionnaire, as he was being asked quite dramatic things like whether he was able to dress himself or cut up his own food. Thankfully his arthritis is well controlled and he doesn’t have any mobility problems, so he can answer “no” to most the questions; I’m guessing other trial participants aren’t so lucky.

The questionnaire he has to fill in is a validated tool for assessing functional disability called the Health Assessment Questionnaire (HAQ).  I’ve come across the questionnaire when reading rheumatology papers – it’s used in patients with a wide variety of rheumatic diseases including rheumatoid arthritis, osteoarthritis, lupus, and ankylosing spondylitis – so I was intrigued to get a proper look at it.

Given how much I go on about clinical research, Dad was keen to be involved in a trial himself and hopefully contribute a small part to improving treatment for rheumatoid arthritis.  There’s also a history of heart disease in my family, so (potentially) receiving a statin when he otherwise wouldn’t be on the list to do so could prove doubly beneficial for Dad.

I’m looking forward to following my Dad’s progress in the trial and reading the first published paper.  The design of the trial seems pretty solid so any positive findings could have considerable implications for how patients with rheumatoid arthritis are treated.  And my Dad – subject number whatever out of n=4000 or so – is playing his own little part.

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