Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada.
Lancet Oncol
; 19(5): e267-e274, 2018 05.
Article
em En
| MEDLINE
| ID: mdl-29726391
ABSTRACT
The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Participação do Paciente
/
Formulação de Políticas
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United States Food and Drug Administration
/
Aprovação de Drogas
/
Medidas de Resultados Relatados pelo Paciente
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Desenvolvimento de Medicamentos
/
Política de Saúde
/
Neoplasias
/
Antineoplásicos
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Limite:
Humans
País como assunto:
America do norte
/
Europa
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article