Post Trial Funding

Tuesday 11 December 2007

Drug Trial Sponsors Must Take More Responsibility

 

Sponsors of commercially-funded research into new treatments must take more responsibility for the wellbeing of the subjects of their studies, according to a new statement [pdf] issued by the Faculty of Public Health (FPH) and Association of Directors of Public Health (ADPH).

In particular they should ensure that subjects are made fully aware - before they consent to take part - of what will happen regarding funding of the treatment once the trial period is over.

People taking part in such trials can often build up their hopes about the outcome of the treatment and assume that they will be given the drugs indefinitely. Very often, however, it falls to local Primary Care Trusts (PCTs) to fund the treatment beyond the end of the trial period.

Current legislation requires the trial sponsor to detail 'the plan for treatment or care of subjects once their participation in the trial has ended' is in place. But FPH and ADPH believe there is still insufficient clarity and patients can suffer as a result.

All research involving human subjects has to be presented to an ethics committee, and it is absolutely essential that agreement on whether any post-trial treatment will be funded, and by whom, is reached before research ethics approval is granted.

If the sponsor is not going to provide ongoing funding once the trial has ended, then commissioners will have to look carefully at a new treatment to see if it is suitable for all appropriate patients to receive it rather than just the ones who have been in a trial.

However, all funding decisions for new treatments have public health implications, says the Statement, as PCTs operate within fixed budgets and constantly have to make difficult decisions about what should be funded.

It is therefore not in the public's best interest that the NHS automatically picks up the bill for experimental treatments whose effectiveness has not been established, at the risk of diverting funding from more beneficial treatments and services.

‘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' says co-author of the Statement, consultant in public health Jonathan Howell.

'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. This means that there is a clear ethical obligation towards them on the part of those funding the research.

'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 continues.

'PCTs often don't know what trials are going on until they're over so it's the trial sponsors who should make it clear what's going to happen when those trials are finished.'

Nicola Close, Chief Executive of the Association of Directors of Public Health says ‘This is a real issue for Directors of Public Health which causes concern for primary care trusts and avoidable stress for patients'.

Ends

Notes to editors

  1. For further information contact Chloe Parkin, Faculty of Public Health
    T: 020 7935 3115 or 07717 000681
  2. A copy of the statement has been issued with the press release and will be available on the Faculty of Public Health website from 8.30am Tuesday 11 December at www.fph.org.uk/advocacy/action. The statement has been sent to a wide range of organisations that can influence this agenda.
  3. The Faculty of Public Health is the leading professional body for public health specialists in the UK. It aims to promote and protect the health of the population, and improve health services, by maintaining professional and educational standards, advocating on key public health issues, and providing practical information and guidance for public health professionals.
  4. The Association of Directors of Public Health (ADPH) is the representative body for Directors of Public Health in the UK. It seeks to improve and protect the health of the population by facilitating the sharing of good practice and presenting the views of Directors of Public Health on public health policy to national governments. www.adph.org.uk.

 

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