Abstract
Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain
Highlights
Stakeholders in medical research trials have a responsibility to provide continued access to investigational products
The need to plan for the follow up of trial participants involving advanced therapy medicinal products and active implantable medicinal devices is detailed in regulatory guidance.[3,4]
With some level of damage expected from the necessary surgical procedures, and the possibility that neural stimulation itself may affect long-term network behaviour[27] it means that participants from an optogenetic trial will likely end up worse off to some degree without active therapy
Summary
Stakeholders in medical research trials have a responsibility to provide continued access to investigational products. If at the end of a trial a participant is seeing benefit from the experimental treatment, a sponsor can recognise their contribution to research by providing ongoing access to care.
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