Admissible two-stage designs for phase II cancer clinical trials that incorporate the expected sample size under the alternative hypothesis

2012 ◽  
Vol 11 (2) ◽  
pp. 91-96 ◽  
Author(s):  
Adrian P. Mander ◽  
James M.S. Wason ◽  
Michael J. Sweeting ◽  
Simon G. Thompson
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Phase Ii ◽  
Alternative Hypothesis ◽  
Cancer Clinical Trials ◽  
Two Stage ◽  
Expected Sample Size

Two-stage seamless transition design from open-label single-arm to randomized double-arm clinical trials

2016 ◽  
Vol 27 (1) ◽  
pp. 158-171 ◽  
Author(s):  
Haolun Shi ◽  
Guosheng Yin
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Phase Ii ◽  
Therapeutic Effects ◽  
Operating Characteristics ◽  
Phase Ii Trials ◽  
Open Label ◽  
Two Stage ◽  
Trade Offs ◽  
Experimental Drug

Conventional phase II clinical trials use either a single- or multi-arm comparison scheme to examine the therapeutic effects of the experimental drug. Both single- and multi-arm evaluations have their own merits; for example, single-arm phase II trials are easy to conduct and often require a smaller sample size, while multiarm trials are randomized and typically lead to a more objective comparison. To bridge the single- and double-arm schemes in one trial, we propose a two-stage design, in which the first stage takes a single-arm comparison of the experimental drug with the standard response rate (no concurrent treatment) and the second stage imposes a two-arm comparison by adding an active control arm. The design is calibrated using a new concept, the detectable treatment difference, to balance the trade-offs between futility termination, power, and sample size. We conduct extensive simulation studies to examine the operating characteristics of the proposed method and provide an illustrative example of our design.

Admissible two-stage designs for phase II cancer clinical trials

2004 ◽  
Vol 23 (4) ◽  
pp. 561-569 ◽  
Author(s):  
Sin-Ho Jung ◽  
Taiyeong Lee ◽  
KyungMann Kim ◽  
Stephen L. George
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Cancer Clinical Trials ◽  
Two Stage
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