Draft guidance on clinical trials recognises needs of non-commercial researchBMJ 2004; 329 doi: https://doi.org/10.1136/bmj.329.7459.191-b (Published 22 July 2004) Cite this as: BMJ 2004;329:191
- Susan Mayor
Academic researchers are cautiously welcoming new draft guidance on clinical trials published recently by the European Commission.
They are pleased that, for the first time, guidance makes specific mention of the particular value and needs of non-commercial clinical trials. They had feared that the previous directive might restrict certain trials or place unnecessary restrictions on studies comparing one existing drug with another where the risks were relatively low.
The new guidance is a redraft of the original European Union clinical trials directive (2001/20/EC), which was set up to harmonise approval and monitoring of commercially sponsored clinical research in different EU countries and to set pan-European standards of protection for all participants in clinical trials. The directive was …