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Trials regulation hindering child cancer progress, say experts

World News | February 21, 2013


Lynne Taylor

Trials regulation hindering child cancer progress, say experts

Overly-complex European Union (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 this week in The Lancet Oncology, which focuses on improving cancer care for children and young people.

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

Over the last half century, improved treatments mean the overall survival rate for cancers in children has increased from around 30% to about 80%. 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 1-15, say the experts. More research could help further improve survival rates, reduce the toxicity of existing treatments and minimise side effects often experienced later in life, they note.

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, says Richard Sullivan, professor of cancer policy and global health at King's College London.

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

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

"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,” adds Professor Ian Magrath from the International Network for Cancer Treatment and Research in Belgium.

Commenting on the publications, Kate Law, director of clinical research at Cancer Research UK, agrees that the EU Directive has been a "barrier to research" which has increased bureaucracy and made it harder to set up multinational trials, but she is encouraged by the EU’s intention to revise the legislation. "Cancer Research UK has lobbied for a long time to make it easer to set up clinical trials," she says.

- Meantime, the chairman of the Paediatric Committee (PDCO) of the European Medicines Agency (EMA), Daniel Brasseur, said this week that "in the near future, sick children can expect to be treated like adults, with medicinal products having been formulated and investigated according to their specific needs."

"A constant dialogue between the PDCO and different drug developers (academia, industry and also patient associations) has enabled us to come closer to this goal," he said.

Under the EU Paediatric Regulation which came into force in 2007, pharmaceutical companies have a legal obligation to develop all new medicines for children as well as for adults through a paediatric investigation plan (PIP), unless they obtain an exemption, or waiver.

Between the first meeting of the PDCO in July 2007 and January 2013, the PDCO assessed 1,340 new applications for PIPs or product-specific waivers, of which 76% related to new medicinal products. A total of PIPs have been completed, leading to new paediatric indicators for 24 medicines and to new pharmaceutical forms appropriate for children for seven medicines, it says.

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