More patients are taking part in cancer trials in the UK now than at any point in the last three decades according to a new report published in this week’s edition of the British Journal of Cancer1.
The increase should significantly improve the health and quality of life for cancer patients as clinical trials are the fastest, surest and a safe way to find new methods of preventing, detecting, diagnosing and treating cancer.
The study looked at trends in clinical trials in the UK between 1971 and 2000 using the National Register of Cancer Trials (NRCT). It showed that there has been a sustained rise in the total number of patients taking part in trials over the last 30 years plus a trend towards larger, multi-centre trials.
The time taken to complete trials has fallen from approximately seven years to two years, due to the impact of the increased recruitment rate. This should allow more trials to take place and, therefore, speed research into new treatments and procedures.
According to the report, Cancer Research UK has funded over a quarter (27 per cent) of cancer trials, making it the second largest funding source of cancer trials in the UK after the Government funded Medical Research Council who funded 30 per cent.
Multi-centre trials involve patients from several centres and have the advantage that patient recruitment is quicker. This allows trials to be larger and the results to be statistically more secure. Conclusions from multi-centre trials also have a broader more representative patient base.
However, there is a potential cloud on the horizon. The European Clinical Trials Directive 2001/20/EC, which came into effect on the 1st April 2004, is intended to standardise regulation of clinical trials across the European community. But, Cancer Research UK is concerned the new wide ranging regulations will lengthen the time it takes to complete clinical research and considerably push up the cost of trials without offering meaningful improvements for trial participants above the previous regulations.
Claire Vale, co-author of the report, who is based at the MRC Clinical Trials Unit, says, “The results from our study are very encouraging as they show a clear improvement in cancer clinical trials over the last 30 years. It will be interesting to revisit our findings in the future to investigate whether recent changes in the law have impacted on these trends.”
Professor John Toy, Medical Director for Cancer Research UK, which owns the BJC, says, “The findings of this study are great news as clinical trials are necessary to develop effective treatments and procedures, leading to new cures, longer lives and imprtovements in the quality of lives of cancer patients.”
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- Trends in UK Cancer trials: results from the UK Coordinating Committee for Cancer Research National Register of Cancer Trials. C. Vale, L. Stewart and J. Tierney. British Journal of Cancer, Volume 92 (5).
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Trials listed on the NRCT have been conducted on a wide variety of cancer types, although almost a third of these trials have been in either breast cancer, 22 per cent (114 trials), or lung cancer, eleven per cent (59 trials).
Clinical trials in cancer aim to find out if a new treatment or procedure is: acceptably safe, has any side-effects, works better than currently used treatments/procedures or helps patients feel better. The full name of the new European law is, “Directive of the European Parliament and of the Council in the approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.” The Regulations provide a statutory basis for: standardisation of procedures for ethical and competent authority consideration and authorisation Good Clinical Practice (GCP) standards for commencing and conducting clinical trials Good Manufacturing Practice (GMP) standards for medicines used in clinical trials inspections against internationally accepted principles and standards of GCP and GMP, supported by enforcement powers.
Cancer Research UK’s patient information website CancerHelp UK is an invaluable source of information for patients wishing to understand how trials work, their relevance for treatment, or to find a clinical trial that may be suitable for them. It also offers a wealth of information about cancer, diagnosis and treatment for patients and their families.
