Linked Life Data

2954005

Source:http://linkedlifedata.com/resource/pubmed/id/2954005

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
1987-6-26
pubmed:abstractText
The advantages of multicenter trials are numerous: quicker recruitment of the necessary number of patients, clearer results which are more convincing and whose acceptance is higher, as the patient sample of multicenter trials is supposed to be representative. However, multicenter trials require strong efforts for quality assurance concerning admission, treatment and follow-up, thus a highly developed coordinating center is needed. Data on recruitment and protocol compliance, i.e. deviations from the study protocol, are presented for the study of the treatment of metastatic renal cell carcinoma and discussed with respect to their impact on the results of the study. 102 patients were randomized either for IFN alpha-2C or IFN alpha-2C plus medroxyprogesteroneacetate. 16% of the patients violated inclusion criteria and essential data were missing in 16% of the patients. Overall treatment results (remission rate of 5.6%, median survival time of 7 months) and the data on adverse events have been biased by lack of protocol compliance. However, the results concerning the lack of differences between treatments remain valid.
pubmed:language
ger
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
0378-584X
pubmed:author
pubmed:issnType
Print
pubmed:volume
10
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
43-9
pubmed:dateRevised
2009-11-19
pubmed:meshHeading
pubmed:year
1987
pubmed:articleTitle
[Advantages and problems of multicenter therapy studies exemplified by a study of the treatment of metastasizing renal cell carcinoma with recombinant interferon-alpha-2c].
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, English Abstract, Randomized Controlled Trial, Research Support, Non-U.S. Gov't