Record number of patients enrol in clinical trials

The number of cancer patients taking part in clinical trials has leapt by over 70 per cent in the last two years, according to new figures to be announced by Cancer Research UK’s Professor Peter Selby at a conference¹.

The increase has been achieved through the establishment of the National Cancer Research Network (NCRN), set up by the government in 2001 to improve the speed and quality of clinical research in the UK, and to double the number of cancer patients entering clinical trials.

But all the good work will be threatened if bureaucratic new regulations come into force, Professor Selby will warn. Cancer Research UK is greatly concerned that an EU ‘Clinical Trials’ Directive due to be incorporated into national law this year will seriously restrict or stop publicly funded clinical trials – doubling the amount of paperwork and quadrupling the cost.

The National Cancer Research Network was established by the Department of Health in April 2001, as part of the National Cancer Research Institute initiative. It aims to enable research organisations – including Cancer Research UK – to run more trials and to recruit patients into them faster.

The NCRN has since succeeded in increasing recruitment into clinical trials from 3.75 per cent of adults diagnosed with cancer annually prior to the network’s establishment, to 6.5 per cent in its second year.

Publicly funded organisations such as Cancer Research UK play a pivotal role in carrying out important research into diseases and treatments that are of little commercial interest to drugs companies. These include research into many childhood cancers and trials of new combinations of existing treatments and drugs.

In addition to providing a vital testing ground for new drugs, clinical trials benefit the patients who take part in them by providing high quality monitoring and care.

But this vital work could be severely slowed when the Medicines for Human Use (Clinical Trials) Regulations 2003 are imposed on UK clinical research on the 1st May 2004.

Cancer Research UK – which is the major funder of non-commercial, publicly funded cancer trials in the UK – is to be part of a steering group set up by the Department of Health to address the main problems arising from the legislation.

Under the proposed legislation, clinical trials funded by charities and universities would be required to fit one model of running clinical trials. Cancer Research UK believes this fails to recognise the robust systems that public funders already have in place to ensure high-quality research and patient safety.

Furthermore the resulting bureaucracy of implementing these new systems could lead to a fourfold increase in the cost of running clinical trials without improving patient safety or trial quality. As a result there will be fewer trials available to patients and important clinical questions will remain unanswered.

Cancer Research UK’s Professor Selby says: “The establishment of the NCRN has been a tremendous success, and we’re now reaping the rewards with more participants in clinical trials than we’ve ever had before.

“But it would be tragic if all that progress were swept away at a stroke by the introduction of bureaucratic and inflexible legislation.”

Dr Richard Sullivan, Cancer Research UK’s Head of Clinical Programmes, says: “The aim of the original European Directive from which this legislation springs – to simplify the process for allowing patients access to clinical trials across Europe – will not be achieved.

“Although we are pleased to be working with the Government, the MRC and the MHRA to address this threat to non-commercial trials – and the potential loss to patients – it is important that the UK legislation is drafted and implemented in the most pragmatic manner to ensure the continuation of publicly funded clinical trials”, he adds.

ENDS