155
Views
8
CrossRef citations to date
0
Altmetric
Original Articles

Discussion of “Some Controversial Multiple Testing Problems in Regulatory Applications”

, &
Pages 14-21 | Received 27 Aug 2008, Accepted 10 Oct 2008, Published online: 07 Jan 2009

REFERENCES

  • Bloch , D. A. , Lai , T. L. , Tubert-Bitter , P. ( 2001 ). One-sided tests in clinical trials with multiple endpoints . Biometrics 57 : 1039 – 1047 .
  • Chi , G. Y. H. ( 1998 ). Multiple testings: multiple comparisons and multiple endpoints . Drug Information Journal 32 : 1347S – 1362S .
  • Chuang-Stein , C. , Stryszak , P. , Dmitrienko , A. , Offen , W. ( 2007 ). Challenge of multiple co-primary endpoints: a new approach . Statistics in Medicine 26 : 1181 – 1192 .
  • COZAAR Package Insert. Available at http://www.merck.com/product/usa/pi_circulars/c/cozaar/cozaar_pi.pdf .
  • Dmitrienko , A. , Offen , W. , Westfall , P. H. ( 2003 ). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant . Statistics in Medicine 22 : 2387 – 2400 .
  • Dmitrienko , A. , Molenberghs , G. , Chuang-Stein , C. , Offen , W. ( 2005 ). Analysis of Clinical Trials Using SAS: A Practical Guide . Cary , NC : SAS Press .
  • Dmitrienko , A. , Wiens , B. L. , Tamhane , A. C. , Wang , X. ( 2007 ). Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives . Statistics in Medicine 26 : 2465 – 2478 .
  • Dmitrienko , A. , Tamhane , A. C. , Liu , L. , Wiens , B. L. ( 2008 ). A note on tree gatekeeping procedures in clinical trials . Statistics in Medicine 27 : 3446 – 3451 .
  • Eaton , M. L. , Muirhead , R. J. (2007). On a multiple endpoints testing problem. Journal of Statistical Planning and Inference 137:3416–3429.
  • Estrogen and estrogen/progestin drug products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms—recommendations for clinical evaluation . ( 2003 ). FDA draft guidance for industry. Available at http://www.fda.gov/cder/guidance/index.htm#clinical%20medicine .
  • ICH E9 ( 2000 ). Statistical principles for clinical trials. Step 5 guidance document available at http://www.ich.org .
  • Offen , W. , Chuang-Stein , C. , Dmitrienko , A. , Littman , G. , Maca , J. , Meyerson , L. , Muirhead , R. , Stryszak , P. , Boddy , A. , Chen , K. , Copley-Merriman , K. , Dere , W. , Givens , S. , Hall , D. , Henry , D. , Jackson , J. D. , Krishen , A. , Liu , T. , Ryder , S. , Sankoh , A. J. , Wang , J. , Yeh , C. H. ( 2007 ). Multiple co-primary endpoints: Medical and statistical solutions. A report from the multiple endpoints expert team of the pharmaceutical research and manufacturers of America . Drug Information Journal 41 : 31 – 46 .
  • Patient-reported outcome measures: use in medical product development to support labeling claims . ( 2006 ). FDA draft guidance for industry. Available at http://www.fda.gov/cder/guidance/index.htm#clinical%20medicine
  • Providing clinical evidence of effectiveness for human drug and biological products . ( 1998 ). FDA guidance for industry. Available at http://www.fda.gov/cder/guidance/index.htm#clinical%20medicine
  • Snapinn , S. ( 2004 ). Considerations for Developing a Composite Endpoint . Presented at the PhRMA Workshop on Statistical, and Regulatory Challenges of Multiple Endpoints. October 20–21 , Washington , DC .
  • Tamhane , A. C. , Logan , B. R. ( 2004 ). A superiority-equivalence approach to one-sided tests on multiple endpoints in clinical trials . Biometrika 91 : 715 – 727 .

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.