【摘 要】
：
The development and evaluation of novel cancer therapeutics is a complex and costly process, with increasing emphasis placed on concentrating resources on agents that have a high probability of eventu
【机 构】
：
Section of Magnetic Resonance Institute of Cancer Research and Royal Marsden Hospital UK
【出 处】
：
BIT‘s2nd Annual World Cancer Congess-2009 (2009第二届癌症大会)
论文部分内容阅读
The development and evaluation of novel cancer therapeutics is a complex and costly process, with increasing emphasis placed on concentrating resources on agents that have a high probability of eventual successful licensing for clinical use.A key stage in this process is the early stage clinical trials of agents, where the need to assess the pharmaeokinetics, toxicity and safe dosage of therapeutics is now being extended also to obtain evidence that the agents are acting in the manner intended.Pharmacodynamic endpoints are now an important aspect of early stage clinical trials, and in the UK a sub-committee (PTAC) of the Cancer Research UK New Agents Committee evaluates the design of new early stage trials to ensure incorporation of appropriate PK and PDS endpoints.While in some cases surrogate endpoints such as hair follicles or circulating cells may be helpful, tumour tissue from biopsies provides an important resource, but can be hard to obtain, in some cases may not be ethically feasible, and is often limited to only one time point.
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