Could you be a human guinea pig? Find out why, every year, hundreds of people sign up for clinical trials on new drugs and treatments...
In 1985, scientists at the giant pharmaceutical company Pfizer were carrying out research into treatments for angina, and the most promising drugs were eventually given to real patients with severe angina. With one drug, an interesting side effect occured – male patients started getting frequent erections. After further research, Viagra was launched in 1998 as a treatment
for impotence.
Few trials make headlines in the way that Viagra did, but ongoing testing is still hugely important. Many of the drugs in daily use, from chemotherapy for cancer patients, to the retroviral drugs that treat HIV/AIDS symptoms have been clinically tested. Patients with these diseases now enjoy longer lives, and of a much higher quality.
On test
Before drugs and treatments find their way into hospitals and chemists, they will be subject to extensive laboratory and animal testing. If the results are positive, clinical trials – the use of drugs on patients – can begin.
There are three minimum stages. In phase one tests, small doses of treatment are given to a few, usually healthy, people to check for side effects. Stage two sees the sample sent to larger numbers of people, usually those who have the condition it aims to treat. At this point, the drug is being monitored for safety and for effectiveness.
If stages one and two are viewed as successful, stage three trials can commence. These are usually carried out in much bigger numbers – often on thousands of people. The new drug is tested alongside its existing rival medications or a placebo.
Volunteers are often recruited from responses to advertisements. However, if the trial is for a specific condition, doctors registered with the Medical Research Council (MRC, www.mrc.ac.uk) can ask patients if they want to be involved.
Taking part in research
Volunteers for trials generally have to be aged between 18 and 75. The motivation to join a clinical trial will vary from person to person.
For some, the decision to volunteer comes from a long-held desire to improve the lot of others; we all expect good healthcare, and much of it is largely dependent on volunteers for clinical trials. However for others, like Juliet Tizzard, taking part is a response to personal circumstances.
‘When I was giving birth to my son Lucas, he became distressed so I had an emergency Caesarean under general anaesthetic. When I woke up, Lucas was in special care,’ says Julia. ‘Within a couple of hours, the paediatrician told us he’d been deprived of oxygen just before birth. Because of this, some of his brain cells had been destroyed.
‘We were asked if we’d take part in a trial of a new treatment for babies like Lucas. At that point, we were in a tailspin; I was recovering from the anaesthetic and hadn’t even seen him, but we agreed. When we heard an hour or two later that he’d been assigned to the treatment arm of the study, it felt like our first bit of good luck.
‘For three days, he was kept in a cooled cot that reduced his body temperature by 3°. His MRI scan came back normal, but we were told we wouldn’t know for a year-and-a-half whether he was going to be healthy.
‘Fortunately, the treatment worked for Lucas and he got the all-clear by specialists at 18 months. The trial showed that cooling reduces the likelihood of brain damage by 57% and the process has now been adopted as an NHS guideline for treating all oxygen-deprived newborns.’
Seeking a cure
The charity Cancer Research UK (www.cancerresearchuk.org) is one of the largest medical charities in the country and plays a pivotal role in clinical trials. Last year, it spent more than £42 million on cancer trials and related studies. Kate Law, director of clinical research, says: ‘The number of cancer patients volunteering for clinical trials in the UK has quadrupled in the past decade, with nearly one in six now taking part – more than anywhere else in the world.
‘It’s a vital part of developing new ways of treating, detecting and preventing cancer. With more patients than ever taking part, we hope even more lives can be savedin future. We are so grateful to volunteers. Without clinical trials, we wouldn’t know which treatments are best for cancer patients.’
Claire Bosanquet, whose sons Jack, 11, and Tom, 9, have Duchamp muscular dystrophy, an inherited muscle-wasting disease, cherishes the same hope. Last year, the boys took part in the clinical trial of a new drug that works to correct the faulty gene to slow the disease down.
‘The overriding thing for me and my husband is that we have two children with a life-limiting condition that you can’t do anything about,’ she says.
‘Being involved in the trial, even though it may not lead to a cure, has been very positive. There’s really been a change in Tom. He definitely has more energy.’
'Testing a diarrhoea drug took me to Mexico'
Ann Haigh, 54, is from Staffordshire. She took part in a medical trial that involved travelling to the city of Guatemala with her son Dominic…
‘I’d just been made redundant from my job and decided to cheer myself up by going on holiday with my son Dominic, 24. He spotted a newspaper ad asking for volunteers for a medical trial to test a new treatment for travellers’ diarrhoea that would involve a holiday to Guatemala in Mexico. We jumped at the chance!
‘The company running the trial – Synexus – told us we could pull out any time. We had to go for a medical at Synexus’ Midlands Clinical Research Centre where staff checked our medical history and completed a full health check.
‘During the trial we were given one of two patches, like a sticking plaster, that we put on our arms, one with medication to prevent travellers’ diarrhoea – and one was a placebo. We were told to go and enjoy ourselves and we did!
‘We ate food from street vendors, travelled to other parts of Mexico and all we had to do was check into a clinic in Guatemala twice. We also had to keep a ‘stools diary’ which was hilarious! We got paid £400 each, and neither of us had an upset stomach once. I feel proud that I have helped make a contribution to medical research and I’d definitely do it again.’
The above feature was
published in at home's
'Ask the Doctor with
Dr Chris Steele' in
April 2011.
Click here for more
Dr Chris Steele.
Image: Getty
