Clinical trials for children with cancer in Europe – Still a long way from harmonisation: A report from SIOP Europe
Abstract Clinical trials for children with cancer have been particularly hard hit by the introduction of the EU Clinical Trials Directive in 2004. Largely investigator-led and lacking in commercial sponsorship, they have struggled to find the resources necessary to comply with the complex bureaucrac...
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| Veröffentlicht in: | European journal of cancer (1990) 2008-10, Vol.44 (15), p.2106-2111 |
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| container_title | European journal of cancer (1990) |
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| creator | Pritchard-Jones, K |
| description | Abstract Clinical trials for children with cancer have been particularly hard hit by the introduction of the EU Clinical Trials Directive in 2004. Largely investigator-led and lacking in commercial sponsorship, they have struggled to find the resources necessary to comply with the complex bureaucracy. These rare diseases require multinational participation to permit appropriately powered clinical trials to be undertaken. Differences in interpretation of the Directive by national regulatory authorities have had a disproportionate effect on trials in children, highlighted by differences in what is deemed an ‘investigational medicinal product’ when paediatric use of an old drug is outside its licensed indication. Insurance costs have increased a 100-fold with no increase in actual risk between consecutive trials from the same study group. Issues raised at the recent conference held to reappraise the operation of the Directive are summarised to emphasise the particular issues for trials in children with cancer. |
| doi_str_mv | 10.1016/j.ejca.2008.07.026 |
| format | Article |
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Largely investigator-led and lacking in commercial sponsorship, they have struggled to find the resources necessary to comply with the complex bureaucracy. These rare diseases require multinational participation to permit appropriately powered clinical trials to be undertaken. Differences in interpretation of the Directive by national regulatory authorities have had a disproportionate effect on trials in children, highlighted by differences in what is deemed an ‘investigational medicinal product’ when paediatric use of an old drug is outside its licensed indication. Insurance costs have increased a 100-fold with no increase in actual risk between consecutive trials from the same study group. 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Largely investigator-led and lacking in commercial sponsorship, they have struggled to find the resources necessary to comply with the complex bureaucracy. These rare diseases require multinational participation to permit appropriately powered clinical trials to be undertaken. Differences in interpretation of the Directive by national regulatory authorities have had a disproportionate effect on trials in children, highlighted by differences in what is deemed an ‘investigational medicinal product’ when paediatric use of an old drug is outside its licensed indication. Insurance costs have increased a 100-fold with no increase in actual risk between consecutive trials from the same study group. Issues raised at the recent conference held to reappraise the operation of the Directive are summarised to emphasise the particular issues for trials in children with cancer.</description><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Child</subject><subject>Childhood cancer</subject><subject>Clinical Trials as Topic - legislation & jurisprudence</subject><subject>Clinical Trials as Topic - standards</subject><subject>Drugs, Investigational - therapeutic use</subject><subject>Ethics, Research</subject><subject>EU Clinical Trials Directive</subject><subject>Europe</subject><subject>European Union</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>IMP definition in paediatrics</subject><subject>Medical sciences</subject><subject>Neoplasms - drug therapy</subject><subject>Pharmacology. Drug treatments</subject><subject>Research Support as Topic - legislation & jurisprudence</subject><subject>Research Support as Topic - standards</subject><subject>Tumors</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9ksFu1DAURS0EokPhB1ggb2CX8GwnToxQpWrUQqVKRRpYWx7nhXHIxIOdUM2Of-AP-ZI6mggkFqy88LnX1nmPkJcMcgZMvu1y7KzJOUCdQ5UDl4_IitWVyqAu-WOyAlWqrIZCnZFnMXYAUNUFPCVnCSorpviKTOveDc6ano7BmT7S1gdqd65vAg703o07as1gMVA30Ksp-APS3z9_0c3o-p4a2vvhK703R9oGv6c7E_Z-cNGMzg_v6CUNePBhPF1ubu4-LRXPyZM2PYYvlvOcfLm--rz-mN3efbhZX95mthBqzKSVnImaoQAhWtUwVkHLhWigKXnFiprXTEnYVgWzW66MkUYwZJJjKWtkpTgnb069h-C_TxhHvXfRYt-bAf0UtVRVmUTIBPITaIOPMWCrD8HtTThqBnqWrTs9y9azbA2VTrJT6NXSPm332PyNLHYT8HoBTEyK25BMuviH42lMAHzm3p84TC5-OAw6WofJeuMC2lE33v3_Hxf_xO0y1G94xNj5KQzJsmY6cg16M6_FvBVQA5RlIcUD_8mxTA</recordid><startdate>20081001</startdate><enddate>20081001</enddate><creator>Pritchard-Jones, K</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20081001</creationdate><title>Clinical trials for children with cancer in Europe – Still a long way from harmonisation: A report from SIOP Europe</title><author>Pritchard-Jones, K</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-6c621381e3033f9d1170f233d0d527148281960b741cb29aa6a31e162e568e153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Child</topic><topic>Childhood cancer</topic><topic>Clinical Trials as Topic - legislation & jurisprudence</topic><topic>Clinical Trials as Topic - standards</topic><topic>Drugs, Investigational - therapeutic use</topic><topic>Ethics, Research</topic><topic>EU Clinical Trials Directive</topic><topic>Europe</topic><topic>European Union</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>IMP definition in paediatrics</topic><topic>Medical sciences</topic><topic>Neoplasms - drug therapy</topic><topic>Pharmacology. 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| identifier | ISSN: 0959-8049 |
| ispartof | European journal of cancer (1990), 2008-10, Vol.44 (15), p.2106-2111 |
| issn | 0959-8049 1879-0852 |
| language | eng |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Biological and medical sciences Chemistry, Pharmaceutical Child Childhood cancer Clinical Trials as Topic - legislation & jurisprudence Clinical Trials as Topic - standards Drugs, Investigational - therapeutic use Ethics, Research EU Clinical Trials Directive Europe European Union Hematology, Oncology and Palliative Medicine Humans IMP definition in paediatrics Medical sciences Neoplasms - drug therapy Pharmacology. Drug treatments Research Support as Topic - legislation & jurisprudence Research Support as Topic - standards Tumors |
| title | Clinical trials for children with cancer in Europe – Still a long way from harmonisation: A report from SIOP Europe |
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