Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.
Ann Epidemiol
; 26(11): 735-740, 2016 11.
Article
en En
| MEDLINE
| ID: mdl-27663208
ABSTRACT
Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
/
United States Food and Drug Administration
/
Resultado del Tratamiento
/
National Cancer Institute (U.S.)
/
Neoplasias
/
Antineoplásicos
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Male
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Ann Epidemiol
Asunto de la revista:
EPIDEMIOLOGIA
Año:
2016
Tipo del documento:
Article