Reflections on the conduct of cell therapy clinical trials in medical institutes / 中华医学科研管理杂志
Chinese Journal of Medical Science Research Management
;
(4): 2-6, 2023.
Artículo
en Chino
| WPRIM
| ID: wpr-995819
ABSTRACT
Objective:
This paper introduces the concepts of " patient-centered cell therapy research management model", to provide reference for domestic medical institutions which conduct cell therapy clinical trials.Methods:
We reviewed and summarized the experiences of conducting cell therapy at Peking University Shenzhen Hospital, including challenges and response plans regarding to the technology assessment, ethical evaluation risks and regulatory compliance. According to which, this paper aims to explore the reflections and practical experience of establishing a patient-centered, multi-stakeholder shared decision-making research management system.Results:
The " patient-centered cell therapy research management model" ensures the reliability of research results through multi-stakeholder engagement in decision-making and management, adequate technical evaluation, effective ethical review and harmonized scientific research management, which not only meets the urgent health needs of the patient, but also promotes the standardized development of emerging technologies.Conclusions:
The " patient-centered cell therapy research management model" is tailored for the cell therapy research, it is important to promote its further assessment and applications.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
Chinese Journal of Medical Science Research Management
Año:
2023
Tipo del documento:
Artículo
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