251
Views
2
CrossRef citations to date
0
Altmetric
Original Articles

A Free Gift: An Adaptive Strategy in a Single-Arm Trial Using an Exact Test Through the Binomial Distribution

Pages 1127-1136 | Received 22 Oct 2010, Accepted 19 Mar 2011, Published online: 17 Oct 2012

REFERENCES

  • Bauer , P. , Köhne , K. ( 1994 ). Evaluations of experiments with adaptive interim analyses . Biometrics 50 : 1029 – 1041 .
  • Chen , Y. H. , DeMets , D. L. , Lan , K. K. G. ( 2004 ). Increasing the sample size when the interim results are promising . Statistics in Medicine 23 : 1023 – 1038 .
  • Cui , L. , Hung , H. M. J. , Wang , S. J. ( 1999 ). Modification of sample size in group sequential clinical trials . Biometrics 55 : 853 – 857 .
  • Food and Drug Administration . ( 2010 ). Adaptive design clinical trials for drugs and biologics. Guidance for industry. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm201790.pdf
  • Groulx , A. , Moon , K. H. K , Chung , S. C. ( 2007 ). Using SAS to determine sample sizes for traditional 2-stage and adaptive 2-Stage Phase II cancer clinical trial designs. SAS Global Forum, Statistics and Data Analysis, paper 188-2007 .
  • Koyama , T. , Chen , H. ( 2008 ). Proper inference from Simon's two-stage designs . Statistics in Medicine 27 : 3145 – 3154 .
  • Lin , Y. , Shih , W. J. ( 2004 ). Adaptive two-stage designs for single arm Phase IIA cancer clinical trials . Biometrics 60 : 482 – 490 .
  • Liu , Q. , Chi , Y. H. G. ( 2001 ). On sample size and inference for two-stage adaptive design . Biometrics 57 : 172 – 177 .
  • Lydersen , S. , Fagerland , M. W. , Laake , P. (2009). Tutorial in biostatistics recommended tests for association in 2 × 2 tables. Statistics in Medicine 28:1159–1175.
  • Proschan , M. A. , Hunsberger , S. A. ( 1995 ). Designed extension of studies based on conditional power . Biornetrics 51 : 1315 – 1324 .
  • Simon , R. ( 1989 ). Optimal two-stage designs for Phase II clinical trials . Controlled Clinical Trials 10 : 1 – 10 .
  • Wassmer , G. A. ( 1998 ). Comparison of two methods for adaptive interim analyses in clinical trials . Biometrics 54 : 696 – 705 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.