Are participants in clinical trials human guinea pigs or important participants in the bid to advance modern medicine, asks BRIAN O'CONNELL
THE hospitalisation last week of three men who had volunteered to take part in a clinical trial in Cork drew attention to an area of medical research that often passes under the radar. At present 390 medical trials are under way in Ireland. Some of the participants are healthy volunteers; others are patients who have agreed to take part because, to varying degrees, they have the disease that the treatment being trialled is intended to fight. Some of the healthy volunteers spend time as inpatients on clinical wards, or come in every day or week for blood and other tests. There is no accurate number of how many people participate in trials, but it could run into hundreds, perhaps thousands.
Participants are generally paid expenses; the exact sum depends on the length and requirements of the trial. For hard-up college students, or just the plain curious, the trials are a handy way to turn a buck. But the recent cases at Shandon Clinic in Cork, and a more serious incident in England in 2006, when six participants ended up in intensive care, raise questions about the safety of clinical trials.
The trials are advertised widely, from poster campaigns on college campuses to notices online and in local newspapers. Biotrax.com, for example, which calls itself a “research volunteer information, advisory and support group”, has several ongoing clinical trials looking for participants, some at Shandon Clinic. They include an oral soft-tissue study, whose participants are asked to use a specific mouthwash and toothpaste and then are examined by a dentist to see how their mouths have reacted.
Among the others are a dermatology study and a medication study, which involves a 24-hour hospital stay. The participants, who must be over 18, are paid €130 a day or €20 per short visit.
The Irish Medicines Board (IMB), which is looking into the Shandon Clinic hospitalisations, says any Irish trial of a medicinal product “can only start when an ethics committee has issued a favourable opinion and the trial has been authorised by the IMB”. The sponsor of the clinical trial is also “required to be established in the European Community”.
The board says that participation is voluntary and that “these volunteers can range from being fit, healthy people with no underlying medical conditions, to patients with various degrees of the disease against which the product is being tested, depending on the nature and objectives of the particular trial”.
One medical worker in his 20s, who asked not to be named, said he took part in trials at Shandon Clinic while he was a student in Cork some four years ago. “I was doing a medicine/health degree, so I understood the principles and the risks fairly well, and I found it quite interesting. A lot of male [college] students do them as a way of earning cash, which was my main concern as well at the time. It was a trial for Warfarin, an anticoagulant. It involved taking a daily dose, getting blood levels tested during the week, and one or two overnight stays for monitoring,” he says. He was paid about €600.
“I do have one cautionary story, though. A few [male] college housemates took part in the same trial, but the ones without a medicine/health background didn’t really understand what was required of them. One of my housemates was a big drinker and, a few days into the trial, went out drinking, despite having read the disclaimer and guidance supplied by Shandon Clinic that warned not to drink. I had to explain to him the danger of binge drinking on Warfarin, and that it contravened the guidelines – which he’d signed off on – as it would have affected his blood levels.”
Clinical trials are essential for the advancement of medicine and the development of treatments. The IMB lays down strict criteria before products or medicines can be tested in Ireland, and participants are screened rigorously in advance.
Dr Chris Luke, a consultant in emergency medicine in Cork, says that during economically hard times care needs to be taken that vulnerable participants are not exploited.
“I did a lot of these trials as a medical student myself in the 1970s and 1980s. They can be very sore, and can involve a lot of blood tests and so on. For medical students, though, and others looking for extra funds, they are handy.
“There is always the risk of trial problems, and there have been a few infamous cases, such as recently in the UK with the young men in intensive care with multiple organ failure. At the end of the day you can’t have advances in pharmacology or treatment without some element of risk.”
Luke says there are advantages for some sectors of society taking part in these trials and getting to experience, albeit briefly, what life as a patient is like. “I found participating in trials gave me a fascinating insight into what it’s like to be a patient. Being stuck in a ward made me a far more sympathetic doctor.”
