Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost.
Brain Stimul
; 15(5): 1029-1036, 2022.
Article
en En
| MEDLINE
| ID: mdl-35926784
ABSTRACT
BACKGROUND:
Clinical trial participants who benefit from experimental neural devices for the treatment of debilitating and otherwise treatment-resistant conditions are generally not ensured continued access to effective therapy or maintenance of devices at the conclusion of trials. OBJECTIVE/HYPOTHESIS:
Post-trial obligations have been extensively examined in the context of drug trials, but there has been little empirical examination of stakeholder perspectives regarding these obligations in the rapidly growing field of neural device research.METHODS:
This study examined the perspectives of 44 stakeholders (i.e., 23 researchers and 21 patient-participants) involved in implantable neural device trials.RESULTS:
Researchers were concerned about current post-trial management, identified barriers like cost, and suggested ways to improve the system. Many patient-participants were unaware of whether they would have post-trial access, but most thought they should keep devices if beneficial, and agreed with researchers that more should be done to help them keep and maintain these neural devices.CONCLUSION:
To our knowledge, this is the first in-depth examination of researcher perspectives regarding continued access to experimental neural devices and only the second such examination of patient-participant perspectives. These data can help inform future ethical and policy decisions about post-trial access to implantable neurotechnology.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_financiamento_saude
Tipo de estudio:
Health_economic_evaluation
/
Prognostic_studies
Aspecto:
Ethics
Idioma:
En
Revista:
Brain Stimul
Asunto de la revista:
CEREBRO
Año:
2022
Tipo del documento:
Article