Clinical trials in children--How are they implemented?

Abstract:

:Drug metabolism in children may differ from adults and adverse events may occur that are not predictable from the adult experience. Clinical trials of safety and efficacy are needed both for new treatments and those that may already be in use but have not been tested in infants and children. The role and responsibilities of different participants in a trial are discussed, including the steering committee, the clinical and statistical co-ordinating centers, and the data and safety monitoring board. Advantages of external vs internal pilot studies are reviewed. Information that is available on the websites of the Food and Drug Administration and the National Institute of Neurological Disorders and Stroke may be helpful to those planning clinical trials of interventions in children.

journal_name

Pediatr Neurol

journal_title

Pediatric neurology

authors

Hirtz DG,Gilbert PR,Terrill CM,Buckman SY

doi

10.1016/j.pediatrneurol.2005.09.011

subject

Has Abstract

pub_date

2006-06-01 00:00:00

pages

436-8

issue

6

eissn

0887-8994

issn

1873-5150

pii

S0887-8994(05)00638-7

journal_volume

34

pub_type

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