UK to set up new clinical trials agency

The formation of the new agency is proposed at the same time as the axe is taken to quangos and other arms-length agencies across all other areas of government. This includes plans to close 15 agencies that support the National Health Service (NHS), leaving only three existing agencies intact. The new clinical trials body will be in addition to these three.

Health bodies facing the chop include the Human Tissue Authority, which oversees the European Union Advanced Tissue Products legislation and the Human Fertilisation and Embryology Authority, which is responsible amongst other things for awarding licenses for human cloning for embryonic stem cell research.

The proposed clinical trials agency is presented as the route around the red tape that has engulfed clinical research since the coming into force in April 2004 of the EU Clinical Trials Directive. This was intended to harmonise clinical trials activity across Europe, but is widely acknowledged to have had the opposite effect, with different member states implementing its requirements more, or less, stringently.

UK participation in global clinical trials dropped from 6 per cent in 2002, to 2 per cent in 2006.

As yet, the shape of the new clinical research oversight body is undecided. The UK Academy of Medical Science began an investigation of the regulation and governance of clinical studies in May. When he announced the review in May, Michael Rawlins, chair of the working group carrying out the investigation said, “We will look at the broad thrust of the regulatory environment, to ensure the National Health Service takes research to heart and that governance arrangements facilitate research.”

Rawlins is chairing the group in a personal capacity, and not in his role as chairman of the UK’s National Institute for Health and Clinical Excellence (NICE), the country’s health technology assessment body. NICE has itself been singled out as a factor that is driving clinical research out of the UK. But Rawlins claims the question of NICE is not relevant to this investigation. Bureaucracy means the cost of trials is becoming “astronomical”, Rawlins said. “If trials cost, drugs are costly and patients or payers have to meet costs.”

The increase in costs and the flight of trials elsewhere is happening across western Europe. The European Commission has acknowledged the adverse impact of the Directive and is currently consulting on how it should be changed, with a promise to bring in new legislation by November 2011.

In the UK a bewildering number of bodies from local ethics committees to primary care trusts, and the Human Tissue Authority, to the Gene Therapy Advisory Committee, and others, have responsibility for different aspects of research regulation. The picture in regenerative medicine is so complicated that the Department of Health has published a route map to guide companies wishing to set up trials of products such as stem cell therapies.

“There is a strong argument for rationalising this and creating greater strategic coherence around research by placing responsibility for these different aspects of medical research regulations within one arm’s length body,” the Department of Health said in a review of the 18 existing NHS agencies.

Such a body would perform the single technical function of regulating clinical research with the aim of streamlining the process of getting permission to stage trials. In particular, the review recognised that the burden of regulation is deterring small-scale academic trials and says one aim of the new agency should be to make is easier for universities to carry out clinical studies.

Rawlins himself singled out three specific problems with the Clinical Trials Directive that need to be addressed by reforms in the UK.

First, the Directive has not been applied in a manner that is proportionate to the risk. This means for example, that trials of existing marketed drugs in new indications are subject to the same level of oversight as trials involving novel therapies in first in human studies. Similarly, small-scale academic trials are expected to match all the reporting and information standards demanded of large-scale industry sponsored trials.

Second, although the EU Clinical Trials Directive sets out what is required, each Member State has taken the list of requirements and translated them into national laws. While some states adopted a lighter touch, in the UK the Directive is embodied in a 129 page statutory instrument, plus an amendment that is a further 130 pages long. Rawlins said the UK, “adopted the rules to [an] extreme.”

Third, the Directive was agreed between the European Commission and the pharmaceutical industry; academic researchers were not consulted.

When he invited contributions to the review in May, Rawlins said there is a danger new EU legislation “could be even worse”. Instead, he suggested the EU should provide advice on how the Directive is to be interpreted. “There is a real will within the Commission to improve things.”

The investigation was ordered by the previous health minister Andy Burnham but political support for it remains, with the new government saying it will consider the shape of legislation and lay plans for “radical simplification” once the Academy of Medical Sciences files its report in January 2011.

Although the government is committed to maintain spending on frontline health services, it is planning huge cuts elsewhere in public spending, to be announced in October. The aim of the review of health agencies is to cut NHS administrative costs by 45 per cent. In 2009/2010 the 18 agencies under scrutiny in the review employed 18,000 staff and received public funding of £1.6 billion.