Advanced search
Publication Cover
Journal of Biopharmaceutical Statistics Volume 22, 2012 - Issue 3
Submit an article Journal homepage
328
Views
4
CrossRef citations to date
0
Altmetric
Original Articles

A Portfolio-Based Approach to Optimize Proof-of-Concept Clinical Trials

Craig Mallinckrodt Eli Lilly and Company, Indianapolis, Indiana, USACorrespondence[email protected]
,
Geert Molenberghs I-BioStat, Diepenbeek, Belgium
,
Charles Persinger Eli Lilly and Company, Indianapolis, Indiana, USA
,
Stephen Ruberg Eli Lilly and Company, Indianapolis, Indiana, USA
,
Andreas Sashegyi Eli Lilly and Company, Indianapolis, Indiana, USA
&
Stacy Lindborg Eli Lilly and Company, Indianapolis, Indiana, USA
Pages 596-607 | Received 15 Aug 2010, Accepted 15 Feb 2011, Published online: 14 Mar 2012

REFERENCES

  • Chen , C. , Beckman , R. A. ( 2009a ). Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions . Journal of Biopharmaceutical Statistics 19 ( 3 ): 424 – 436 .
  • Chen , C. , Beckman , R. A. ( 2009b ). Optimal cost-effective go-no go decisions in late-stage oncology drug development . Statistics in Biopharmaceutical Research 1 ( 2 ): 159 – 169 .
  • Gelenberg , A. J. , Thase , M. E. , Meyer , R. E. , Goodwin , F. K. , Katz , M. M. , Kraemer , H. C. , Potter , W. Z. , Shelton , R. C. , Fava , M. , Kahn , A. , Trivedi , M. H. , Ninan , P. T. , Mann , J. J. , Bergeson , S. , Endicott , J. , Kocsis , J. H. , Leon , A. C. , Manji , H. K. , Rosenbaum , J. F. ( 2008 ). The history and current state of antidepressant clinical trial design: a call to action for proof–of–concept studies . Journal of Clinical Psychiatry 69 ( 10 ): 1513 – 1528 .
  • Hurko , O. , Ryan , J. L. ( 2005 ). Translational research in central nervous system drug discovery . NeuroRx 2 : 671 – 682 .
  • Johnson , R. A. , Wichern , D. W. ( 1992 ). Applied Multivariate Statistical Analysis. , 3rd ed. Englewood Cliffs , NJ : Prentice Hall .
  • Kola , I. , Landis , J. ( 2004 ). Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery 3 : 711 – 715 .
  • Mallinckrodt , C. H. , Detke , M. J. , Prucka , W. R. , Ruberg , S. J. , Molenberghs , G. ( 2010 ). Design archetypes for Phase II clinical trials in central nervous system disorders . Drug Information Journal 44 ( 4 ): 421 – 430 .
  • Munos , B. H. ( 2009 ). Lessons learned from 60 years of pharmaceutical innovation . Nature Reviews Drug Discovery 8 : 959 – 968 .
  • Paul , S. M. , Mytelka , D. S. , Dunwiddie , C. T. , Persinger , C. C. , Munos , B. H. , Lindborg , S. R. , Schacht , A. L. ( 2010 ). How to improve R&D productivity: The pharmaceutical industry's grand challenge . Nature Reviews Drug Discovery 9 : 203 – 214 .
  • Piantadosi , S. ( 2005 ). Clinical Trials: A Methodological Perspective. , 2nd ed. New York : John Wiley & Sons .

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:

Order Reprints Request Corporate Permissions

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:

Request Academic Permissions

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.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.