Running an international paediatric non-commercial clinical trial.
The current regulations for conducting non-commercial clinical trials in Europe are many and complex. These are explored from the perspective of a UK based non-commercial international clinical trial. The reasons for the difficulties encountered are discussed and suggestions made as to how best to overcome them. Improvements are suggested for our law makers and competent authorities. It is argued that the current regulatory environment could be considered unethical as it inhibits and delays research.
Osborne
J P
JP
Royal United Hospital, Bath, UK. mpsjpo@bath.ac.uk
O'Callaghan
F J K
FJ
D002648:Child; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000379:methods*; D006801:Humans; D007391:International Cooperation; D010372:Pediatrics