rdf:type |
|
lifeskim:mentions |
umls-concept:C0023434,
umls-concept:C0030705,
umls-concept:C0038215,
umls-concept:C0085973,
umls-concept:C0206034,
umls-concept:C0442711,
umls-concept:C0443252,
umls-concept:C0936012,
umls-concept:C1510756,
umls-concept:C1556084,
umls-concept:C2827738
|
pubmed:issue |
5
|
pubmed:dateCreated |
1987-1-2
|
pubmed:abstractText |
The CLL 80 clinical trial of treatment for chronic lymphocytic leukemia was designed using a three-stage prognostic classification. Within each stage patients received one of two treatments allocated by randomization, two adjacent stages having a common treatment. The fixed-sample design required 850 patients entered over a period of 8.5 years. Active patient recruitment led to 741 patients being randomized in four years. The first interim analysis, carried out at this point, showed a treatment difference in one stage which was statistically significant (p = 0.001) and justified an early termination of the protocol. This paper discusses practical aspects of patient accrual and interim analysis in this study.
|
pubmed:language |
eng
|
pubmed:journal |
|
pubmed:citationSubset |
IM
|
pubmed:chemical |
|
pubmed:status |
MEDLINE
|
pubmed:issn |
0277-6715
|
pubmed:author |
|
pubmed:issnType |
Print
|
pubmed:volume |
5
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
Y
|
pubmed:pagination |
465-73
|
pubmed:dateRevised |
2007-11-15
|
pubmed:meshHeading |
pubmed-meshheading:3538262-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:3538262-Chlorambucil,
pubmed-meshheading:3538262-Clinical Trials as Topic,
pubmed-meshheading:3538262-Cyclophosphamide,
pubmed-meshheading:3538262-Doxorubicin,
pubmed-meshheading:3538262-Drug Administration Schedule,
pubmed-meshheading:3538262-France,
pubmed-meshheading:3538262-Humans,
pubmed-meshheading:3538262-Leukemia, Lymphoid,
pubmed-meshheading:3538262-Prednisone,
pubmed-meshheading:3538262-Prognosis,
pubmed-meshheading:3538262-Random Allocation,
pubmed-meshheading:3538262-Research Design,
pubmed-meshheading:3538262-Time Factors,
pubmed-meshheading:3538262-Vincristine
|
pubmed:articleTitle |
Patient accrual and interim statistical analysis in long-term randomized clinical trials: the French chronic lymphocytic leukemia CLL 80 protocol as a case study.
|
pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial
|