Recent Statistical Contributions to Medical Device Development.
Ther Innov Regul Sci
; 48(1): 90-97, 2014 Jan.
Article
en En
| MEDLINE
| ID: mdl-30231414
ABSTRACT
Clinical trials in the development of new medical device products are in many ways analogous to clinical trials in the development of new drug or biologic products. However, the differences are important and not always intuitive to a statistician with only experience supporting development of drug and biologic products. In this paper we discuss some of the interesting differences with focus on the statistical innovation that is coming out of the medical device area. We discuss examples of the differences in clinical trial design and effects of these differences on clinical development programs.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2014
Tipo del documento:
Article
País de afiliación:
Estados Unidos