Adaptive designs, Continual reassessment method, Dose escalation, Dose-finding, Maximum tolerated dose, Phase I trialsIntroduction The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM ...
The article offers information on the benefits of Multiple Comparison Procedure-Modelling (MCP-MOD) approach over traditional approaches for testing the doses of drugs against placebo, an ineffectual treatment for diseases.doi:10.1038/nrd4193NATURE REVIEWS DRUG DISCOVERY...
The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting the MTD than traditional rule-based approach
optimal study designtwo-stage designOften in clinical trials the observed responses are continuous but a regulatory agency will approve the drug only if the probability is sufficiently large that the efficacy measure exceeds a predefined threshold and the toxicity does not exceed another given threshold...
Design and Analysis of Dose-Finding Studies
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 ...
We propose a dose-finding weighted design for an early clinical trial which aims to determine the optimal dose, selected on the basis of both efficacy and toxicity, to be used in patients entering subsequent studies in a drug development process. The goal is to identify the optimal dose, whil...
Our numerical study helps illuminate the recent result of Azriel et al. (2011):namely, that no design attempting to generate a sequence of exclusive MTD-only3As this article goes to press, a proof has been found; a related manuscript is in review.11Oron et al.: Dose-Finding Convergence...
Summary Dose finding methods aiming at identifying an optimal dose of a treatment with a given schedule may be at a risk of misidentifying the best treatment for patients. We propose a phase I–II clinical trial design to find the optimal dose–schedule combination. We define schedule as the...
复方制剂应该进行剂量探索(Dose-finding)研究,以确定复方中各成分的最适比例和剂量。复方制剂剂量探索研究的内容既包 … www.med66.com|基于1191个网页 2. 剂量确定 临床试验剂量确定(dose-finding)的设计、计算、演示 药物临床试验的安全性定量评价与后续试验的剂量选择 时辰药理学 … ...