Source:http://linkedlifedata.com/resource/pubmed/id/18211657
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
1
|
| pubmed:dateCreated |
2008-1-23
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| pubmed:abstractText |
Long-term observational studies are essential in assessing the effect of interventions for chronic diseases on long-term safety and tolerability, as well as informing on efficacy in a non-clinical trial setting. Concerns over the scientific validity of open label extension studies to randomized controlled trials have recently been raised. Patients experiencing adverse events will be withdrawn before the follow-on period of the study, and those experiencing milder side-effects will be less likely to opt to continue into the open label extension.
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
IM
|
| pubmed:status |
MEDLINE
|
| pubmed:month |
Feb
|
| pubmed:issn |
1365-2753
|
| pubmed:author | |
| pubmed:issnType |
Electronic
|
| pubmed:volume |
14
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
141-4
|
| pubmed:meshHeading |
pubmed-meshheading:18211657-Defibrillators,
pubmed-meshheading:18211657-Ethics, Clinical,
pubmed-meshheading:18211657-Ethics, Research,
pubmed-meshheading:18211657-Humans,
pubmed-meshheading:18211657-Patient Selection,
pubmed-meshheading:18211657-Randomized Controlled Trials as Topic,
pubmed-meshheading:18211657-Research Design,
pubmed-meshheading:18211657-Selection Bias
|
| pubmed:year |
2008
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| pubmed:articleTitle |
Open label extension studies and patient selection biases.
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| pubmed:affiliation |
Department of Statistics, University of Warwick, Warwick, UK. karla@stats.warwick.ac.uk
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| pubmed:publicationType |
Journal Article,
Research Support, Non-U.S. Gov't,
Meta-Analysis
|