scholarly journals Proportional odds model for dose-finding clinical trial designs with ordinal toxicity grading

2011 ◽  
Vol 30 (17) ◽  
pp. 2070-2080 ◽  
Author(s):  
Emily M. Van Meter ◽  
Elizabeth Garrett-Mayer ◽  
Dipankar Bandyopadhyay
Keyword(s):  
Clinical Trial ◽  
Proportional Odds Model ◽  
Dose Finding ◽  
Proportional Odds ◽  
Clinical Trial Designs

Clinical Trial Designs for the Early Clinical Development of Therapeutic Cancer Vaccines

2001 ◽  
Vol 19 (6) ◽  
pp. 1848-1854 ◽  
Author(s):  
Richard M. Simon ◽  
Seth M. Steinberg ◽  
Michael Hamilton ◽  
Allan Hildesheim ◽  
Samir Khleif ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Vaccines ◽  
Chemotherapeutic Agents ◽  
Clinical Development ◽  
Dose Finding ◽  
Tumor Vaccines ◽  
Wide Range ◽  
Clinical Trial Designs ◽  
Therapeutic Cancer Vaccines

ABSTRACT: There are major differences between therapeutic tumor vaccines and chemotherapeutic agents that have important implications for the design of early clinical trials. Many vaccines are inherently safe and do not require phase I dose finding trials. Patients with advanced cancers and compromised immune systems are not good candidates for assessing either the toxicity or efficacy of therapeutic cancer vaccines. The rapid pace of development of new vaccine candidates and the variety of possible adjuvants and modifications in method of administration makes it important to use efficient designs for clinical screening and evaluation of vaccine regimens. We review the potential advantages of a wide range of clinical trial designs for the development of tumor vaccines. We address the role of immunological endpoints in early clinical trials of tumor vaccines, investigate the design implications of attempting to use disease stabilization as an end point and discuss the difficulties of reliably utilizing historical control data. Several conclusions for expediting the clinical development of effective cancer vaccines are proposed.

scholarly journals Incorporating adverse event relatedness into dose-finding clinical trial designs

2013 ◽  
Vol 33 (7) ◽  
pp. 1146-1161 ◽  
Author(s):  
Darsy Darssan ◽  
Mery H. Thompson ◽  
Anthony N. Pettitt
Keyword(s):  
Clinical Trial ◽  
Adverse Event ◽  
Dose Finding ◽  
Clinical Trial Designs

scholarly journals New clinical trial designs for HIV vaccine evaluation

2013 ◽  
Vol 8 (5) ◽  
pp. 437-442 ◽  
Author(s):  
Zoe Moodie ◽  
Holly Janes ◽  
Yunda Huang
Keyword(s):  
Clinical Trial ◽  
Hiv Vaccine ◽  
Clinical Trial Designs
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