EU Guidance To Tackle Sponsor/Investigator Overlap In Decentralized Trials

The upcoming pan-EU recommendation paper on decentralized clinical trials (DCTs) will offer guidance on the tricky subject of how sponsors and investigators can demonstrate control over their respective responsibilities in such studies.

The problem arises because in DCTs – in which certain trial activities are conducted remotely and in, or near, participants’ homes – sponsors can be seen to be getting involved in certain tasks (eg, contracting home nurses and remote physicians, etc) that traditionally fall within the investigator’s remit of protecting the rights, safety and welfare of trial subjects