EU regulations "threaten trials"
risen over 70 per cent in recent years, but this trend will be
threatened if the EU adopts its proposals on GCP
The number of UK cancer patients taking part in clinical trials has risen over 70 per cent in recent years, but this positive trend will be threatened if the European Commission presses ahead with its proposals on Good Clinical Practice.
This stark warning has been delivered by Peter Selby, director of Cancer Research UK's Clinical Centre at St James' University Hospital, Leeds, at a conference organised by the medical charity.
This increase has been achieved through the establishment of the National Cancer Research Network, set up by the government in 2001 to improve the speed and quality of clinical research in the UK and also double the number of patients entering clinical trials.
During its second year, the NCRN succeeded in increasing recruitment into clinical trials from 3.75 per cent of adults diagnosed with cancer to 6.5 per cent. However, the European Union Directive on Good Clinical Practice in Clinical Trials (2001 /20/EC), which is to be incorporated into UK legislation on May 1, 2004, "will seriously restrict or stop publicly-funded trials - doubling the paperwork and quadrupling the cost," said Prof Selby.
He added that the trials run by publicly-funded groups such as Cancer Research UK will be me most at risk, noting that these "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."
This work will be hampered by UK's Medicines for Human Use (Clinical Trials) Regulations 2003, which spring directly from the EU Directive, This would require all trials funded by charities and universities to fit one model and fails to recognise the "robust systems" that publicly-funded groups already have in place to ensure high-quality research and patient safety.
Richard Sullivan, Cancer Research UK's head of clinical programs, warned " the aim of the original EU Directive - to simplify the process for allowing patients access to clinical trials across Europe - will not be achieved."
Over the past five years, Cancer Research has funded over 65 large Phase III non-commercial cancer trials and is now supporting over 50 that recruit, on average, 6,000 patients a year. It has also completed 29 early-phase trials on completely new drugs in the same period.
