Call for EU regulators to get tougher on pediatric clinical trials for cancer drugs
Children with cancer are being denied potentially life-saving drugs because European Union rules are allowing companies to trial some drugs only in adults, leading cancer experts warn today.
Changes to how EU rules are implemented could allow children access to more potential cancer drugs which have currently only been tested in adults by making it more difficult for pharma companies to avoid testing them in under-18s.
Under the EU current system, pharma companies often gain exemptions from carrying out expensive testing of cancer drugs in patients under the age of 18, even where a drug’s mechanism of action suggests it could work in children. As a result there are significant delays in new drugs becoming available for children, and some drugs may never be formally licensed for pediatric use.
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