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10.1002/sim.6124 http://scihub22266oqcxt.onion/10.1002/sim.6124 C4048734!4048734!24577750     free     free     free Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Stat+Med 2014 ; 33 (16): 2718-35 Nephropedia Template TP {{tp|p=24577750|t=2014. A New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Chemotherapies |pdf=|usr=}}{{24577750}} gab.com Text A New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Chemotherapies JO: Stat Med http://www.kidney.de/pget.php?&tw=1&pmid=24577750 #FOAvip Recently there has been much work on early phase cancer designs that incorporate both toxicity and efficacy data, called Phase I-II designs because they combine elements of both phases. However, they do not explicitly address the Phase II hypothesis test of H0: p ? p0, where p is the probability of efficacy at the estimated maximum tolerated dose (MTD) ?? from Phase I and p0 is the baseline efficacy rate. Standard practice for Phase II remains to treat p as a fixed, unknown parameter and to use Simon?s 2-stage design with all patients dosed at ??. We propose a Phase I-II design that addresses the uncertainty in the estimate p = p(??) in H0 by using sequential generalized likelihood theory. Combining this with a Phase I design that incorporates efficacy data, the Phase I-II design provides a common framework that can be used all the way from the first dose of Phase I through the final accept/reject decision about H0 at the end of Phase II, utilizing both toxicity and efficacy data throughout. Efficient group sequential testing is used in Phase II that allows for early stopping to show treatment effect or futility. The proposed Phase I-II design thus removes the artificial barrier between Phase I and Phase II, and fulfills the objectives of searching for the MTD and testing if the treatment has an acceptable response rate to enter into a Phase III trial. Twit Text FOAVip A New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Chemotherapies ????Stat Med http://www.kidney.de/pget.php?&tw=1&pmid=24577750 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=24577750 #FOAvip English Wikipedia <ref>{{Cite pmid|24577750}}</ref> A New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Chemotherapies #MMPMID24577750 Bartroff J; Lai TL; Narasimhan B Stat Med 2014[Jul]; 33 (16): 2718-35 PMID24577750show ga Recently there has been much work on early phase cancer designs that incorporate both toxicity and efficacy data, called Phase I-II designs because they combine elements of both phases. However, they do not explicitly address the Phase II hypothesis test of H0: p ? p0, where p is the probability of efficacy at the estimated maximum tolerated dose (MTD) ?? from Phase I and p0 is the baseline efficacy rate. Standard practice for Phase II remains to treat p as a fixed, unknown parameter and to use Simon?s 2-stage design with all patients dosed at ??. We propose a Phase I-II design that addresses the uncertainty in the estimate p = p(??) in H0 by using sequential generalized likelihood theory. Combining this with a Phase I design that incorporates efficacy data, the Phase I-II design provides a common framework that can be used all the way from the first dose of Phase I through the final accept/reject decision about H0 at the end of Phase II, utilizing both toxicity and efficacy data throughout. Efficient group sequential testing is used in Phase II that allows for early stopping to show treatment effect or futility. The proposed Phase I-II design thus removes the artificial barrier between Phase I and Phase II, and fulfills the objectives of searching for the MTD and testing if the treatment has an acceptable response rate to enter into a Phase III trial. äA New Approach to Designing Phase I-II Cancer Trials for Cytotoxic Che(epmc).pdf DeepDyve Pubget Overpricing