A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC).
Ther Innov Regul Sci
; 53(2): 243-248, 2019 03.
Article
em En
| MEDLINE
| ID: mdl-29714573
ABSTRACT
BACKGROUND:
Janssen Research & Development, LLC, part of the Janssen pharmaceutical companies of Johnson & Johnson, and NYU School of Medicine partnered to establish the Compassionate Use Advisory Committee (CompAC) to evaluate the use of an independent, external, expert committee in ensuring transparent, fair, beneficent, evidence-based, and patient-focused compassionate access to investigational medicines, a public health challenge that has been an ongoing issue for over 3 decades.METHODS:
To this end, NYU School of Medicine was responsible for the formation, member selection, and operation of CompAC, consisting of physicians, ethicists, and patient advocates, under Johnson & Johnson's sponsorship.RESULTS:
A pilot was successfully run using CompAC to provide recommendations on compassionate use access to a Johnson & Johnson oncology investigational asset called daratumumab.CONCLUSION:
This innovative model provides a framework that can be emulated by the industry globally.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Drogas em Investigação
/
Comitês Consultivos
/
Ensaios de Uso Compassivo
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article