Linked Life Data

20237212

Source:http://linkedlifedata.com/resource/pubmed/id/20237212

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
2010-3-18
pubmed:abstractText
The U.S. Food and Drug Administration grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. The clinical trial endpoints that have been used to support approval in the oncology setting have evolved over the last 30 years commensurate with an improved understanding of the natural history of cancers and the mechanisms of action of drugs. Overall survival is the gold standard for a registration trial designed to gain marketing approval; however, additional endpoints have been used in the approval of oncology drugs. Advantages of specific endpoints are discussed, including the accuracy of an endpoint's measurement and its relation to clinical benefit. Surrogate endpoints may be acceptable for "accelerated" approval, with a sponsor commitment to provide evidence of clinical benefit in a subsequent trial.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:issn
1549-490X
pubmed:author
pubmed:issnType
Electronic
pubmed:volume
15 Suppl 1
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
13-8
pubmed:meshHeading
pubmed:year
2010
pubmed:articleTitle
The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.
pubmed:affiliation
U.S. Food and Drug Administration, Silver Spring, Maryland 20993, USA. amy.mckee@fda.hhs.gov
pubmed:publicationType
Journal Article