Costs of complying with directive threaten paediatric trialsBMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a1605 (Published 10 September 2008) Cite this as: BMJ 2008;337:a1605
- Roger Dobson
The capacity of clinical trials for children with cancer in Europe is threatened by a struggle to find resources to conform with a European Union directive, a report says.
Increases in the bureaucracy and expense of monitoring trials, a 100-fold rise in insurance costs, and problems created by the requirement for a single European trial sponsor are among the reasons highlighted in the report from the European branch of the International Society of Paediatric Oncology (European Journal of Cancer 2008 Aug 29, doi:10.1016/j.ejca.2008.07.026).
It says that trials for children with cancer have been particularly hard hit by the introduction of the EU Clinical Trials Directive in 2004.
“Until recently, over 70% of …