Guidelines on drug trials in children go out for consultationBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7570.673-b (Published 28 September 2006) Cite this as: BMJ 2006;333:673
- Rory Watson
Draft guidelines on the ethics of clinical trials involving children have been put out for public consultation by the European Commission and the European Medicines Agency.
The guidelines have been drawn up in line with EU legislation on the conduct of good clinical practice in trials of medicinal products for human use. This legislation specifically called for criteria to be agreed to protect children.
The guidelines are directed at sponsors of clinical trials, ethics committees, and investigators of clinical trials involving children of all ages (from birth to 18 years of age). They …