A comparative analysis of paediatric dose-finding trials of molecularly targeted agent with adults’ trials

2013 ◽  
Vol 49 (10) ◽  
pp. 2392-2402 ◽  
Author(s):  
Xavier Paoletti ◽  
Birgit Geoerger ◽  
François Doz ◽  
André Baruchel ◽  
François Lokiec ◽  
...  
Keyword(s):  
Comparative Analysis ◽  
Dose Finding ◽  
Targeted Agent ◽  
Paediatric Dose

scholarly journals A decision-theoretic phase I–II design for ordinal outcomes in two cycles

Biostatistics ◽  
2016 ◽  
Vol 17 (2) ◽  
pp. 304-319 ◽  
Author(s):  
Juhee Lee ◽  
Peter F. Thall ◽  
Yuan Ji ◽  
Peter Müller
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Solid Tumors ◽  
Simulation Study ◽  
American Statistical Association ◽  
Dose Finding ◽  
Backward Induction ◽  
Advanced Solid Tumors ◽  
Statistical Association ◽  
Targeted Agent

Abstract This paper is motivated by a phase I–II clinical trial of a targeted agent for advanced solid tumors. We study a stylized version of this trial with the goal to determine optimal actions in each of two cycles of therapy. A design is presented that generalizes the decision-theoretic two-cycle design of Lee and others (2015. Bayesian dose-finding in two treatment cycles based on the joint utility of efficacy and toxicity. Journal of the American Statistical Association, to appear) to accommodate ordinal outcomes. Backward induction is used to jointly optimize the actions taken for each patient in each of the two cycles, with the second action accounting for the patient's cycle 1 dose and outcomes. A simulation study shows that simpler designs obtained by dichotomizing the ordinal outcomes either perform very similarly to the proposed design, or have much worse performance in some scenarios. We also compare the proposed design with the simpler approaches of optimizing the doses in each cycle separately, or ignoring the distinction between cycles 1 and 2.

1207: Failed Pyeloplasty in Children: Comparative Analysis of Retrograde Endopyelotomy VS. Re-do Pyeloplasty

2007 ◽  
Vol 177 (4S) ◽  
pp. 398-398
Author(s):  
Luis H. Braga ◽  
Joao L. Pippi Salle ◽  
Sumit Dave ◽  
Sean Skeldon ◽  
Armando J. Lorenzo ◽  
...  
Keyword(s):  
Comparative Analysis
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