Post-trial access to implantable neural devices: an exploratory international survey.

Nathan HigginsJohn GardnerAnna WexlerPhilipp KellmeyerKerry O'BrienAdrian Carter

Published in: BMJ surgery, interventions, & health technologies (2024)

On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.

Keyphrases

study protocol
phase iii
phase ii
clinical trial
randomized controlled trial
primary care
open label
decision making
double blind
placebo controlled