Agreement will bring more patients into trials
In January 2003, the ABPI/Department of Health joint Model Clinical Trial Agreement (MCTA) was launched by the then Health Minister Lord Hunt. Its purpose is to make the contracting arrangements for industry-approved clinical trials performed in NHS secondary/tertiary care Trusts easier and provide faster start-up times for trials. A survey performed on behalf of the ABPI indicated that the vast majority of trusts planned to use the MCTA. Start-up times are a key benchmark in measuring the efficiency of a country in the clinical trial arena and was a major component of the Pharmaceutical Industry Competitiveness Task Force Clinical Research Working Group activity.

Because of the perceived success of the MCTA, a further model agreement for Clinical Research Organisations, sponsors and NHS Trusts is currently being developed, and an MCTA for primary care research will probably be developed. This should enable more UK patients to be entered into sponsored clinical trials. This will be of benefit, particularly for patients, as it has long been recognised that patients in clinical trials receive better care and experience better outcomes than those patients with the same condition but not in a trial.

In December, the Director General joined a high level working party established by the Trade Minister and the Minister for Health to find even better ways of improving research for patients’ benefit in the NHS. The group is due to report in the spring of 2004.

Trials register brings better clarity
Clinical trials involving healthy volunteers and patients play an essential role in the search to understand, prevent and treat disease. Their aim is to evaluate new medicines and other types of therapies to determine their potential benefits and safety. Attracting clinical trials to the UK is important for patients, for the NHS, for the academic world and for the nation’s economy. Their presence here means that patients have potential early access to the newest forms of treatment, together with the highest standards of medical care.

The ABPI Clinical Trial Register was launched in May 2003. The register, which is managed by the Centre for Medicines Research International on behalf of ABPI, is voluntary and consists of details of Phase 3 trials involving UK patients of a licensed medicine. Companies are invited to register the relevant trials three months after the introduction of the medicine in a major market. Companies are also invited to register any Phase 4 and SAMM trials involving that medicine prospectively. By early 2004, five member companies, Aventis, MSD, Novartis, Schering Healthcare and Wyeth, had registered 88 trials, with a number of others considering joining.

Since the launch, it has been possible to refute a lot of the criticism about the perceived secrecy of the industry in the clinical trial area. There is no doubt that registering trials indicates an important level of transparency within the clinical research area and the move has been widely welcomed. It is a public website and it is believed to be the only industry clinical trial register in the world. Its website address is https://www.cmrinteract.com/clintrial.

Key European Directive is delayed
The European Clinical Trials Directive is due for implementation across all the 25 Member States of the Europe Union on 1 May 2004, but the European Commission has failed to publish fully all the supporting Directives. The Medicines Control Agency published draft UK legislation to transpose the Directive in February 2003, but UK final legislation has had to be put off because of the delays in Europe. However, a recent Government announcement indicated that the UK legislation will be in place by 1 May 2004, thus making the UK compliant, a move which is welcomed by the ABPI.

There has been a lot of criticism, particularly from the academic community, about the Directive, but the ABPI believes that, if it is carefully implemented, the Directive will ensure that all interventional trials involving medicines will be performed to the highest standards, and this can only benefit patients. With the ABPI’s excellent relationship with the Medicines and Healthcare products Regulatory Agency, there is no reason why the UK cannot continue to be seen as the best place in Europe to do clinical research.

One important statistic to support this is that during 2003, the Government was able to announce that eight per cent of cancer patients are now in clinical trials, more than double the figure for 2000, and double the current figure for the US. This is a great benefit to cancer patients in the UK and the ABPI recognises the vital role of the National Cancer Research Network (NCRN) in delivering this target a year ahead of schedule.