Experts from 19 countries believe further progress is being threatened by increasingly strict research regulations and insufficient development of new drugs.
The Lancet Oncology Series is published to coincide with a special event hosted by Glenis Willmott, Member of the European Parliament (MEP), which will debate these issues at the EU parliament today.
Although more children and young people in high-income countries are surviving cancer than ever before, cancer remains the leading cause of death from disease in children aged 1 to 15 years, and more than 5000 children still lose their lives to cancer every year in these regions.
Increased participation in international, collaborative clinical trials has successfully raised survival from 30 per cent to 80 per cent over the last half century. However, Richard Sullivan, professor of cancer policy and global health at King’s College London and King’s Health Partners Integrated Cancer Centre, said: ‘An increasingly complex and strict regulatory environment for clinical research and data sharing is limiting children’s access to early-phase clinical trials and delaying the development of new drugs.
‘For example, the implementation of the EU Clinical Trials Directive, in 2004, has almost quadrupled costs, led to substantial delays, and even the discontinuation of trials.’
The research identifies a number of factors that lead to longer clinical development, including: the complex nature of the biology underlying childhood cancers; the difficulty of identifying targets suitable for drug treatment; a lack of long-term sustainable funding for research and development, particularly outside the USA; and little economic incentive for pharmaceutical companies to develop anticancer drugs adapted for children.
According to the researchers, fast-tracking the most relevant and new medicines for childhood cancers will require a renewed focus on the potential role of adult cancer drugs in children as well as newer methods and clinical trial design that aim to more rapidly predict the optimal (i.e, effective and safe) dose.
In recent years, it has been industry that has driven the clinical trials in children to meet regulatory requirements rather than the paediatric oncology expert community who understand the clinical unmet needs of children and young people with cancer, write the authors. ‘The trend in the past few years for industry to drive the development of clinical research plans contrasts with the need for broad research and development partnerships that can deal with complex biology and drug development.’
As well as drug development challenges, more needs to be done to address the long-term consequences of cancer treatment. Estimates suggest that one in 1000 adults in high-income countries are survivors of childhood cancer, and 40 per cent of these survivors experience adverse effects throughout life.
‘These are serious issues that can have a real impact on a person’s quality of life’, said Professor Sullivan. He added: ‘It is essential that academic programmes and trial investigators ensure better follow-up of survivors to appropriately address the complications childhood cancer survivors may experience in later life.’
The authors conclude by calling on every country to develop a national cancer plan that recognises the unique demographic and care needs of young people with cancer, adding that, ‘If policy makers continue to fail to pay attention to this issue then in 10 years…the infrastructure will not be in place to deal with what will have become the most common disease-related cause of death in childhood.’
Notes to editors
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