Trial volunteers 'left in lurch'

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Patients who take part in drug trials are being left in the lurch once the research is completed, doctors warn.

People assume they will be given the treatment indefinitely with the NHS picking up the bill, the Faculty of Public Health said.

But primary care trusts have limited budgets and cannot pay for treatments before the effectiveness has been established, they stressed.

Industry experts agree patients needed to be aware that treatment may end.

The warning comes after a row over funding for a new drug called eculizumab for patients with a rare genetic disorder, paroxysmal nocturnal haemoglobinuria.

At the very least they should be told very clearly before they consent that either there will not be any ongoing funding from the drug company, or that the company will continue the funding until other funding is in place Dr Jonathan Howell

It costs £300,000 per patient per year and there were 40 patients in the trial.

Dr Jonathan Howell, a consultant in public health in the West Midlands, said a health technology assessment was being done to look at how effective the drug was.

But in the meantime, PCTs were being put under pressure to pay for the treatment.

There have also been recent battles over access to multiple myeloma drug lenolidamide.

Some patients who took part in the extended access trial have been able to continue on treatment where others found their PCT would not fund it.

High hopes

In a statement issued with the Association of Directors of Public Health, the Faculty warned that patients build their hopes up about the outcome of the treatment and believe they will be able to continue taking the drugs.

They said it needed to be made clear what will happen once the research period ends.

It should be made clear... what the position is regarding the supply of the medicine at the end of the trial Richard Ley Association of the British Pharmaceutical Industry

Current legislation requires the trial sponsor to detail a plan for treatment or care of subjects after the research is done.

But there is "insufficient clarity" over who will pick up the bill, the Faculty said, and primary care trusts do not often know that trials are even going on until they are over.

Dr Howell, said it was an increasingly common issue.

"This is all about making sure that the trial sponsor treats the patients fairly and reasonably and that the patients know what is likely to happen to their treatment at the end of the trial."

"The patients are taking some risk, as the reason the research is being carried out in the first place is that the safety and effectiveness of the experimental treatment are uncertain.

"At the very least they should be told very clearly before they consent that either there will not be any ongoing funding from the drug company, or that the company will continue the funding until other funding is in place."

He added that it would not be a great expense for the drug company to continue funding the treatment for trial patients until the NHS has evaluated it.

Richard Ley, spokesperson for the Association of the British Pharmaceutical Industry, said he agreed 100% that patients need to be well-informed.

"Our own guidelines say that it should be made clear either in the trial protocol or the patient consent form what the position is regarding the supply of the medicine at the end of the trial."