Shepherding Therapeutic Cancer Vaccines through Clinical Development

www.clinipace.com

Shepherding
Therapeutic Cancer
Vaccines through
Clinical Development
Contents
Overview of Therapeutic Cancer Vaccines ....................................................... 2
Prior Failures and Lessons Learned .................................................................. 3
Clinical endpoints based on tumor size. ....................................................... 3
Flawed choice of trial design. ........................................................................ 4
Testing in late-stage versus early stage disease. .......................................... 4
Suboptimal dose and regimen. ..................................................................... 5
Scale has its challenges. ................................................................................ 5
Inclusion of the wrong patients .................................................................... 5
Development Strategies for Success ................................................................ 6
Designing and conducting clinical trials ........................................................... 7
Study design. ................................................................................................. 7
Better study management with technology. ................................................ 7
Investigators and study centers. ................................................................... 7
Assays of response. ....................................................................................... 8
Stage of disease............................................................................................. 8
Eligibility criteria. ........................................................................................... 8
Important regulatory relationships. .............................................................. 9
Conclusions ..................................................................................................... 9
References .................................................................................................... 10
About the Authors ........................................................................................ 11
About Clinipace Worldwide ........................................................................... 12

Page | 1

©2011 Clinipace Worldwide, Inc. All rights reserved.