Big rise in volunteers for medical trials

Medical volunteers Medical trial volunteers like Gary Bartlett are vital in developing new treatments

The number of patients taking part in clinical trials in England has trebled in five years.

Figures from the National Institute of Health Research (NIHR) show almost 638,000 patients volunteered last year.

The rise may surprise some, given the publicity associated with a drug trial at a private research unit at London's Northwick Park hospital in 2006.

That trial - of a potential new drug for arthritis - left six volunteers dangerously ill.

A similar increase in volunteers has occurred elsewhere in the UK.

Although many people associate medical trials with healthy volunteers, the vast majority who take part in research are NHS patients testing treatments for their condition.

The chief medical officer, Prof Dame Sally Davies, said she was delighted NHS patients realised the benefits of participation and said they played a vital role in developing treatments.

The increase follows the establishment of the NIHR in 2006. Its remit is to "improve the health and wealth of the nation through research". The organisation, funded by the Department of Health, has increased the amount of patient-focused health research.

Dame Sally said: "We put between 15-20% patients into trials in cancer compared to 2-3% in the United States, so clearly we've managed to get through to the public to explain the advantages of joining clinical research, and the altruistic side of what they are doing for the people that follow them.

Who volunteers?

The vast majority of those who take part in clinical trials are patients who have a specific illness which is being investigated. They will either get the best standard treatment or a novel therapy. While the number of people taking part has trebled in five years to nearly 650,000, the number of new NIHR trials has stayed broadly similar at between 1,000-1,500 per year.

Healthy volunteers are also needed to test new treatments. They will usually get no personal benefit from the medicine they are testing although they do get paid for giving up their time. There are no exact figures for the number of healthy volunteers but the MHRA estimates about 8,000-9,000 take part in trials each year.

"The doctors and patients have properly funded expert support in the clinic - to help patients understand the meaning of taking part in research, their right to opt out if they do consent - and to help them and hold their hands as they go through the research."

The NIHR has launched a campaign - OK to Ask - to encourage patients to raise the subject of clinical research rather than the first approach coming from a clinician. Despite the huge increase in patient numbers on trials, a consumer poll by the NIHR Clinical Research Network found only 6% of those questioned said the public were well-informed about clinical research in the NHS.

Dame Sally also paid tribute to healthy volunteers who tested new treatments. Early trials of medicines are often tested this way.

Permanent damage

In 2006, six men were treated for multi-organ failure in intensive care after testing a new drug in a private research facility at Northwick Park hospital in north-west London. The trial was a "first-in-man" study of a new immunotherapy for leukaemia and rheumatoid arthritis.

The volunteers were injected at intervals of just a few minutes and suffered multi-organ failure. They eventually recovered but have been left with permanent damage to their immune system and other health problems.

The trial had been approved by the MHRA (Medicines and Healthcare Products Regulatory Agency). A subsequent inquiry recommended stricter controls concerning treatments that are being tested in humans for the first time.

There are no exact figures for the number of healthy volunteers on trials, as opposed to patients receiving treatment, but it is widely thought that the numbers rose after the publicity surrounding the Northwick Park incident.

Chart: Clinical trial volunteers by year, England

"People are usually quite shocked when they hear I'm involved in trials and assume it's high risk, but if you read the literature you know that it's very safe," said Gary Bartlett, an accountant from Oxford.

Start Quote

The idea of helping to save lives in countries where typhoid is still a major killer gives you a warm feeling inside”

End Quote Gary Bartlett Medical research volunteer
Typhoid vaccine

He is among nearly 150 volunteers who have been part of a three-year Oxford University trial of a new vaccine against typhoid, funded by the Wellcome Trust. The trial also involved what's known as a "typhoid challenge" where volunteers drink a beaker containing typhoid bacteria to test whether the vaccine prevents the bugs from causing the disease.

Gary developed mild typhoid fever which gave him a flu-like illness and headache. It was treated with antibiotics and did not put him off taking part.

"These trials are so well monitored that you feel well-looked after all the way. You get a couple of days off work - no-one can argue with you if you have typhoid. I also did a trial in London where I contracted malaria but that too was no problem."

Over three years, volunteers on the Oxford trial could earn £3,000. But that involved dozens of visits to the Churchill Hospital and repeated blood tests.

Although the money is welcome, the volunteers I first met 18 months ago seemed motivated more by altruism and an interest in medical research.

Saving lives

"The idea of helping to save lives in countries where typhoid is still a major killer gives you a warm feeling inside," said Mr Bartlett.

Another of the volunteers was Amy Letts, an artist and designer from Oxford. She told me: " They can't test typhoid on animals because it only affects humans. It's a horrible disease so it would be wonderful to get a better vaccine."

Sanitation and a clean water supply helped rid the disease from the developed world. But billions of people in poorer countries are still at risk and it is estimated to claim between 200,000-600,000 lives a year.

Testing the vaccine in Oxfordshire might sound odd, but it means clinicians can control the circumstances in which volunteers are given typhoid. To conduct the same trial in Nepal, one of the countries worst affected by typhoid, would require thousands of volunteers.

Andrew Pollard, professor of paediatric infection at the University of Oxford, paid tribute to the volunteers on his trial at the NIHR Oxford Biomedical Research Centre:

"We are trying to develop life-saving vaccines, and that means preventing children dying, especially in the developing world. Volunteers who come forward are saving the lives of children if they help us to develop these new vaccines."

The preliminary results of the typhoid trial are promising but larger trials are needed if it is to ever become a licensed vaccine. From start to finish, the whole process of creating a new vaccine or drug treatment can take 15-20 years and involve thousands of clinical trial volunteers.

Fergus Walsh Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this

    Comment number 20.

    Well, the NHS already has the "Liverpool Pathway" (Code for let patients die), and the insolent "Presumed consent" when NHS organ snatchers rip out dead peoples` organs without democratic oversight, thought for the citizen, or even permission.
    Seems they are now at least trying to prevent the deaths caused by untested drugs??
    Are they reacting to the 1100 deaths though!??

  • rate this

    Comment number 19.

    @18: hate to tell you this, but everything is tested on animals first. Roll on the time when that's no longer true.

  • rate this

    Comment number 18.

    I wouldn't mind participating in these sort of things, because if it's medication for humans, I'd rather they'd be tested on humans than animals - who don't have the same physiology as us anyway. Problem is, I'm not allowed to because I'm of childbearing age & not sterile. That I don't want or plan on having children is apparently a moot point.

  • rate this

    Comment number 17.

    Is there a central registry of candidates? We could enrol online and then a pharma company could make contact when a relevant trial was being run. Or there could be a list of upcoming trials and we could register our interest. I'm surprised it's so unstructured.

  • rate this

    Comment number 16.

    One point is that whist on these trials you are very well looked after, and have the best medical care at the time paid for by the drug companies. My father-in-Law was told no more help from NHS, he has since died, but he wanted to help others and took time to help. He lived for 6 further months and had the best care whilst on the trial. in believing his results will benifit others in the long run

  • rate this

    Comment number 15.

    a number of years ago i volunteered to do some tests with beechams.
    They put me through a barrage of tests which only took a morning and i even got breakfast thrown in .
    Two weeks later i was advised that they could not use me and i should see my gp turned out they found an imbalance in my liver which if left could of been very dodgy indeed i did not take part in any tests but im still here.

  • rate this

    Comment number 14.

    I think some respect should be given to these "volunteers".

    Lets look at the truth - some are awaiting death or are on borderline, they give their life to maybe preserve YOU.

    A million (no infinite) Thank you's to all who have taken part in these trials.

  • rate this

    Comment number 13.

    @Helene Shaw
    I'm surprised, I really thought you would be paid. But I hope the trial benefits you and other diabetes sufferers.

  • rate this

    Comment number 12.

    How unfair that Northwick Park continues to be tarnished by a trial that had nothing to do with that hospital. The trial was run by Parexel privately in space that it rents on the site. Nothing to do with Northwick or the NHS.

  • rate this

    Comment number 11.

    I took part in a clinical trial whilst undergoing chemo last year. This was mainly down to financial reasons though. I was being treated for bowel cancer and so I had to take six months off work (operation and chemo). If I had not been on the trial I would probably have been off work for nearly a year. I needed to be able to return to work ASAP otherwise I would have lost pay. Forced to take part!

  • rate this

    Comment number 10.

    I am in a voluntary clinical trial into a new insulin. I don't receive payment, I spend a lot of my day inputting data into a PDM, but I also have a lot of help and support for my diabetes.

  • rate this

    Comment number 9.

    Cannot argue that the people deserve to be paid, What disgusts me is that, when the person gets ill and has to take time off work (I.e. typhoid symptoms), the welfare state in the form of direct benefits like SSP or the employer in the form of company sick pay should NOT bear the costs.

  • rate this

    Comment number 8.

    Clinical trials are unavoidable. By definition, one person has to be the first to receive a new treatment. It's risky, someone's got to risk it, at it's fair to pay that person for taking the risk.

    What happened at Northwick Park, however, was inexcusable. It should have been a low dose, increased slowly, one person at a time. Given the drug to six people at a high does was stupid and reckless.

  • rate this

    Comment number 7.

    I am a postgraduate student and I have taken part in four studies, making about £5000 for approx 2-3 weeks in hospital. I have always been in the "healthy volunteer" category, and I am yet to meet anyone who does this for the benefit of advancing medical treatment. Everyone does it for the money.

  • rate this

    Comment number 6.

    To anyone who 'disagrees' with clinical trials, first think of this. Every single drug you take or will ever take in your life has to be tested in clinical trials and approved first with pharmaceutical companies investing millions in that research and not all trials are successful. Still disagree with clinical trials? Thought not.

  • rate this

    Comment number 5.

    Perhaps this is the only way some people can get timely treatment from our "brave new" Tory NHS?

  • rate this

    Comment number 4.

    Or, most fittingly, the private pharmaceutical companies should be paying as they will be ultimately profiting from the successful trials.

  • rate this

    Comment number 3.

    So, not only does the 'volunteer' get paid for the trial, he (probably) gets paid time off work - "who could argue if you have typhoid"?. Yes, the trials are crucial, but neither the welfare system - in the form of SSP - nor the persons employer have to pay the person for taking the risk of contracting the disease. The NHS should be responsible for that. Disgusted at this.

  • rate this

    Comment number 2.

    I have to agree BuzzcoreCrew - and doing this is probably slightly safer than taking to the streets to selll your body - given the going rate for that has fallen and the "requirements" more dodgy because of the "tough ecomomic times".

  • rate this

    Comment number 1.

    What a surprise, in tough economic times people are more inclined to have medicines tested on them...who'd have thought?


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