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@article{GarrettMayer06,
author = {Garrett-Mayer, Elizabeth},
title = {{The continual reassessment method for dose-finding studies: a tutorial}},
journal = {Clinical Trials},
volume = {3},
number = {1},
pages = {57-71},
doi = {10.1191/1740774506cn134oa},
year = {2006},
abstract = {The Continual Reassessment Method (CRM), along with other adaptive dose-finding study designs, has gained popularity since its proposal by O'Quigley. Several of the reasons it has been embraced by clinical trialists is that it tends to incur fewer toxic events, and more accurately estimate the maximum tolerated dose as compared to the standard Phase I dose escalation designs. Many variations have been published and discussed in the statistical literature, but there has not been as much practical advice for choosing design parameters and implementing the CRM. As a result, the CRM has not been as widely utilized as it could be for dose-finding studies. The goal of this paper is to provide a tutorial for those unfamiliar with the CRM who are either statisticians considering using the CRM for the first time, or investigators with some statistical background. This paper presents the original CRM, and then some of its modified versions. It also explains the specifications that define a CRM design, along with simulated examples of CRMs and standard designs, for illustration.
},
% URL = {http://ctj.sagepub.com/cgi/content/abstract/3/1/57},
% eprint = {http://ctj.sagepub.com/cgi/reprint/3/1/57.pdf}
}

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%and Pollock, Raphael E. and Zagars, Gunar K. and Benjamin, Robert S.
%and Ballo, Matthew T.},
% title = {Phase {I} Trial of Preoperative
%Doxorubicin-Based Concurrent Chemoradiation and Surgical Resection
%for Localized Extremity and Body Wall Soft Tissue Sarcomas},
% journal = {J Clin Oncol},
% fjournal = {Journal of Clinical Oncology},
%   volume = {22},
%    number = {16},
%     pages = {3375-3380},
%      year = {2004},
%%       URL ={http://www.jco.org/cgi/content/abstract/22/16/3375},
%%        eprint =
%{http://www.jco.org/cgi/reprint/22/16/3375.pdf},
% }

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@article{YuanChappell04,
author = {Yuan, Zhilong and Chappell, Rick},
title = {Isotonic designs for phase {I} cancer clinical trials with multiple risk groups},
journal = {Clin. Trials},
fjournal = {Clinical Trials},
volume = {1},
number = {6},
pages = {499--508},
doi = {10.1191/1740774504cn058oa},
year = {2004},
abstract = {Background In phase I cancer clinical trials, adjustment for patient differences in toxicity susceptibility can be carried out with stratification into risk groups. Separate trials conducted for each risk group can lead to conflicting decisions, in which higher doses are recommended for higher risk groups. Designs which covariate adjust often require assumptions that clinicians may be uncomfortable with.  Methods We extend up-and-down designs, isotonic designs and the continual reassessment method (CRM) to multiple risk groups with two-way isotonic regression. The only assumption about the groups is that they can be ordered according to their toxicity risk. The first two extensions, in particular, are nonparametric and easy for clinicians to understand.  Results Simulations were based on an ongoing helical tomotherapy trial. Seven different toxicity scenarios were considered. The proposed methods compared favorably to a covariate adjusted CRM. The extended up-and-down designs inherited the conservativeness from the original designs.  Conclusion Our experience demonstrates that the escalation rules of multiple risk groups can be linked, without a parametric assumption about the group toxicity curve, to borrow strength and to ensure nonconflicting dosage recommendations.
},
% URL = {http://ctj.sagepub.com/cgi/content/abstract/1/6/499},
% eprint = {http://ctj.sagepub.com/cgi/reprint/1/6/499.pdf}
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