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Analysis of phase II methodologies for single-arm clinical trials with multiple endpoints in rare cancers: An example in Ewing's sarcoma

Abstract:

Trials run in either rare diseases, such as rare cancers, or rare subpopulations of common diseases are challenging in terms of identifying, recruiting and treating sufficient patients in a sensible period. Treatments for rare diseases are often designed for other disease areas and then later proposed as possible treatments for the rare disease after initial phase I testing is complete. To ensure the trial is in the best interests of the patient participants, frequent interim analyses are ne...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's version

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Publisher copy:
10.1177/0962280216662070

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Department:
Oxford, MSD, NDORMS, CSM
Role:
Author
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Department:
Oxford, MSD, NDORMS, CSM
Role:
Author
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Department:
Oxford, MSD, Pathology Dunn School
Role:
Author
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Grant:
Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 278742 (Eurosarc)
Publisher:
SAGE Publisher's website
Journal:
Statistical Methods in Medical Research Journal website
Volume:
27
Issue:
5
Pages:
1451-1463
Publication date:
2016-09-01
Acceptance date:
2016-07-07
DOI:
EISSN:
1477-0334
ISSN:
0962-2802
Pubs id:
pubs:640249
URN:
uri:49ec1b02-869b-4246-a122-314cd42ebd94
UUID:
49ec1b02-869b-4246-a122-314cd42ebd94
Local pid:
pubs:640249

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