From genomic data analysis to drug development: a new generation of trials using molecular marker assessment in breast cance [0.03%]
从基因组数据分析到药物研发：使用分子标志物评估进行乳腺癌试验的新一代试验
Sophie Doisneau-Sixou,Nadia Harbeck
Sophie Doisneau-Sixou
With the advent of molecular subtypes in breast cancer, the landscape of clinical trials and drug development is rapidly changing. Molecular screening identifies numerous mutations but actually druggable targets are few and far between. Thu...
Integrative oncology drug discovery accompanied by preclinical translational research as prerequisite for clinical development [0.03%]
伴随临床前转化研究的整合肿瘤药物发现作为临床开发的前提条件
Jens Hoffmann
Jens Hoffmann
The molecular heterogeneity of cancer calls for individualized therapies to become the standard of care. It is now generally accepted that target-specific compounds require specific new development programs. But, even for new drugs with gen...
Christophe Le Tourneau,Maud Kamal,Marie Alt et al.
Christophe Le Tourneau et al.
All anticancer molecularly targeted agents on the market today have been approved with one or no companion diagnostic based on a specific genomic molecular alteration. These drugs have followed the same clinical development than chemotherap...
Christian Dittrich
Christian Dittrich
Cancer drug development is undergoing a substantial shift nowadays. The underlying drivers are multi-factorial. On the one side, drug development is performed more rationally than ever, profiting from the scientific advances in molecular bi...
Yong Zang,J Jack Lee
Yong Zang
Adaptive designs have become popular in clinical trial and drug development. Unlike traditional trial designs, adaptive designs use accumulating data to modify the ongoing trial without undermining the integrity and validity of the trial. A...
Isabella C Glitza,Michael A Davies
Isabella C Glitza
Until recently, treatment options for patients with metastatic melanoma were very limited. This landscape has evolved dramatically since the discovery of activating mutations in the BRAF gene in ~45% of cutaneous melanomas. Vemurafenib, dab...
Adaptive randomized phase II design for biomarker threshold selection and independent evaluation [0.03%]
基于自适应随机化的生物标志物阈值选择及独立评价的二期临床试验设计方法研究
Lindsay A Renfro,Christina M Coughlin,Axel M Grothey et al.
Lindsay A Renfro et al.
Background: Frequently a biomarker capable of defining a patient population with enhanced response to an experimental agent is not fully validated with a known threshold at the start of a phase II trial. When such candida...
Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine [0.03%]
符合个性化医疗目标的临床试验所需的药物设计
Sumithra J Mandrekar,Daniel J Sargent
Sumithra J Mandrekar
In the current era of stratified medicine and biomarker-driven therapies, the focus has shifted from predictions based on the traditional anatomic staging systems to guide the choice of treatment for an individual patient to an integrated a...
Prostate carcinoma in transgenic Lewis rats - a tumor model for evaluation of immunological treatments [0.03%]
前列腺癌的转基因Lewis大鼠模型-评估免疫治疗的模型
Laura E Johnson,Jordan T Becker,Jason A Dubovsky et al.
Laura E Johnson et al.
Transgenic rodent models of prostate cancer have served as valuable preclinical models to evaluate novel treatments and understand malignant disease progression. In particular, a transgenic rat autochthonous model of prostate cancer using t...