Trials regulation hindering childhood cancer progress

21 Feb 2013
Trials regulation hindering childhood cancer progress

Overly complex EU regulations are hampering progress on cancer survival rates in children, say leading researchers.


Current cancer treatments in high-income countries are close to reaching their full potential, according to a series of articles published in The Lancet Oncology, which focus on improving cancer care for children and young people.


Less restrictive regulation and new strategies are needed to kick start research, said Professor Kathy Pritchard-Jones from the Institute of Child Health, University College London.


Over the last half century, improved treatments mean the overall survival rate for cancers in children has increased from around 30 per cent to around 80 per cent.


But in the developed world, where improved health care and nutrition has led to better management of children's health, cancer is now the leading cause of death from disease in children aged one to 15.


More research could help further improve survival rates, reduce the toxicity of existing treatments and minimise side effects often experienced later in life.


The introduction of the EU Clinical Trials Directive in 2004 has led to almost quadrupled costs, substantial delays and even the discontinuation of some trials across all types of cancer, Richard Sullivan, professor of cancer policy and global health at King's College London, said.


Other barriers to developing new treatments include the biology underlying childhood cancers, and difficulty of identifying targets suitable for drug treatment, the study said.


"Fostering open collaborations with many groups from industry, regulatory bodies, academia, governments, and patient advocacy will be crucial to speeding up drug development", said co-author Professor Gilles Vassal of Paris-Sud University.


Commenting on the publications, Kate Law, director of clinical research at Cancer Research UK, agreed that the EU Directive has been "a barrier to research" which had increased bureaucracy and made it harder to set-up multinational trials.


But she welcomed recent commitments to revise the Directive.


"Accelerating the development of new treatments for childhood cancers is vital," she added.


"Cancer Research UK has lobbied for a long time to make it easier to set up clinical trials, so we are encouraged by the intention of the EU to revise this legislation and will continue to work to ensure these are able to benefit patients as quickly as possible.


"We have come a long way in the last half century, but increasing the speed with which drug discoveries are brought to trials is essential to ensure new treatments are made available to children with cancer."


Childhood cancer is on the rise across the developing world, despite being seen as an illness of richer countries, according to another paper in the series.


Cancer claims the lives of around 100,000 children before the age of 15 every year worldwide, with more than 90 per cent of those deaths occurring in low-income countries, recent World Health Organisation (WHO) estimates suggest.


"An unknown proportion of children with potentially curable cancers never receive treatment - not even palliative treatment - and most of those who do receive some form of treatment still die”, said Professor Ian Magrath from the International Network for Cancer Treatment and Research in Belgium.


Investment in healthcare systems, equipment and drugs, improved training for health professionals and the creation of regional hospital networks and international collaboration can all help improve childhood cancer outcomes in the developing world, the report said.


Source: CRUK