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, Medical correspondent Article written by Fergus Walsh Fergus Walsh Medical correspondent

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  • rate this
    +3

    Comment number 40.

    In my opinion volunteers for drug trials should ensure that they are going to be insured properly in case things go wrong. They need to be certain that the correct amount of cover is provided, and that they have confidence in the reputation of the insurer. Personally, I would want to see a copy of the insurance policy to make sure that I fully understood the policy.

  • rate this
    +2

    Comment number 39.

    The reason for the increase, given that it is largely made up of people with pre-existing conditions "testing treatments for their own conditions", could be that it is medical research on the cheap.
    The other element is that, in straightened times people will undergo medical trials for money.

  • rate this
    0

    Comment number 38.

    "and the altruistic side of what they are doing for the people that follow them".

    Fair enough but let's not forget the potential millions (indeed billions in some cases) a successful drug or vaccine can make for a drugs corporation.

    I'm all for the progress of medical science but don't forget what really makes the world go around, or am I being too cynical?

  • rate this
    +5

    Comment number 37.

    Big rise in volunteers

    Students are normally the largest group to volunteer

    Big rise in student fees

    No surprises.

  • rate this
    +3

    Comment number 36.

    Not all trials are for drugs. Next month I will be taking part in a trial for a new method of evaluating heart function as a (hopefully) normal volunteer. I get travelling expenses but all the results (which include the current standard test) will be looked at by a senior clinician so I get checked over and may help others and even myself in the future.

  • rate this
    0

    Comment number 35.

    On one hand I'm excited about the all the NHS research plans, not mentioned in this article?! Hoping it will help lots of people around the world. On the other hand I remember the over confident and completely stupid 2006 study. Some treatment costs are extortionately high, benefitting the few. If I was terminally ill I'd still say sign me up despite concerns of abuses, what choice would I have?

  • rate this
    +2

    Comment number 34.

    @17 Androsupial. The idea is that under the new NHS plans every NHS patient will be automatically opted in as a potential clinical trial candidate. The plan is to have everything off the ground in 2015, this is one of many press releases to warm people to the idea. Automatically opting people in has proved controversial as some folks are worried about life insurance companies and genome patents.

  • Comment number 33.

    This comment was removed because the moderators found it broke the house rules. Explain.

  • Comment number 32.

    This comment was removed because the moderators found it broke the house rules. Explain.

  • rate this
    +1

    Comment number 31.

    Not all medical trials involve taking untested drugs, I've been involved in trials for a closed-loop system for diabetics, no additional drugs are involved for that trial for example.

  • Comment number 30.

    This comment was removed because the moderators found it broke the house rules. Explain.

  • rate this
    -2

    Comment number 29.

    "they do get paid for giving up their time" - well there's your answer then. I know someone who told me they do it for the money and, "if it goes wrong, the compensation". Though I do also know people that would do this for (really) free. BBC HYS please open up a proper cause for comment.

  • Comment number 28.

    This comment was removed because the moderators found it broke the house rules. Explain.

  • rate this
    0

    Comment number 27.

    It's about time the Scientists stop these trials and inventing new vaccines to try and save the human race. it's laughable really finding new ways to save more people, only for them to starve to death anyway. There is just too many Humans on this lump of rock we call Earth, we're decimating every other species of animal on this planet, creating so much pollution it's not real. Just stop.

  • rate this
    +3

    Comment number 26.

    It's been standard practice for years for patients with a specific illness to be asked to take part in clinical trials.

    The crashing of our economy probably explains the sharp rise in 'normal controls' - healthy members of the general public who try a new medicine for payment.The botched 2006 drug trial in 2006 is probably not remembered by most of the usually young people taking part.

  • rate this
    +12

    Comment number 25.

    I have an incurable, degenerative and painful illness and, at the age of 37, the word "trial" translates optimistically as "future hope" if not for me, but the next generation of sufferers. When one comes up for my condition, I'll volunteer in the blink of an eye - It's better than the alternative!

  • rate this
    0

    Comment number 24.

    I wonder whether this is the result of animal activists who have put pressure on drug companies to not do animal testing, so the companies now have to do more tests on humans instead.

  • rate this
    +1

    Comment number 23.

    Selling organs soon to follow.......times are hard so why not?

  • rate this
    +1

    Comment number 22.

    Firemensaction, the Liverpool care pathway is about making patients who are extremely unwell and not expected to survive the next 24-48 hours, as comfortable as possible... hence it is not about "Letting people die" as they highly likely to do so imminently anyway

  • rate this
    +2

    Comment number 21.

    Times are hard people need dosh. I know a dude whose floggin a lung. Its not me. I just know him...

 

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