Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2000-6-8
pubmed:abstractText
Multiple sclerosis is currently an incurable disease and there is much interest in developing new disease-modifying treatments and testing them in clinical trials. Because therapies are essentially partially effective, neurologists have to develop ways to assess whether the medication they test slows down the course of the disease. Promising treatments selected for Phase III clinical trials are first tested in Phase I/II studies, where preliminary evidence of efficacy is demonstrated in the absence of severe adverse events. Phase III clinical trials are designed to detect significant differences between responses to active therapies and a placebo or a marketed drug. The selection and usage of instruments to detect changes in patients is probably the most important issue in their design. The purpose of this paper is to discuss methodological problems of evaluating drug efficacy in phase III MS trials, including the characteristics of the ideal instrument to measure progression of the disease, the strengths and limitations of existing clinical, radiologic and laboratory outcome measures.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Mar
pubmed:issn
0369-8114
pubmed:author
pubmed:issnType
Print
pubmed:volume
48
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
104-13
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed:year
2000
pubmed:articleTitle
Methodological problems in evaluating efficacy of a treatment in multiple sclerosis.
pubmed:affiliation
UCSF/Mt Zion Multiple Sclerosis Center 94115-1642, USA.
pubmed:publicationType
Journal Article, Review