Linked Life Data

9839638

Source:http://linkedlifedata.com/resource/pubmed/id/9839638

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
1999-1-29
pubmed:abstractText
The domination of the randomized controlled clinical trial in clinical research in breast cancer is questioned in the context of adjuvant therapy. The criteria for selection of cases by TNM classification are shown to be poorly related to tumour behaviour. The factors that determine outcome--the presence or absence of metastases, their size at the time of presentation of the primary cancer and their growth rate--are not measured. Metastases cannot be detected at sizes below about 10 mm in diameter. This represents about 30 doublings of volume or three-quarters of the life span of the tumour. There is no identifiable starting point for a trial. It is possible to estimate growth rates from the rates of shrinkage in response to primary medical treatment. Modelling of the times at which metastases may appear in the clinic from different possible starting sizes reveals that the usual end points of time from primary diagnosis to metastasis or death have an enormous intrinsic variability. Treatment is merely another confounding variable. The randomized controlled clinical trial is shown to be a poor tool for the investigation of adjuvant treatments. An alternative approach, based upon observation of individual tumour response to primary medical treatment, is commended.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
1356-1294
pubmed:author
pubmed:issnType
Print
pubmed:volume
4
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
119-26; discussion 127-30
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
1998
pubmed:articleTitle
Problems associated with randomized controlled clinical trials in breast cancer.
pubmed:affiliation
Breast Study Centre, Mount Vernon and Watford Hospitals NHS Trust, Mount Vernon Hospital, Northwood, Middlesex, UK.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't