Adherence Assessment for Supplements

描述(申请人提供)：膳食补充剂的使用在美国已经变得越来越流行，这些补充剂不受严格的上市前测试或上市后监督。超过三分之一的美国成年人报告使用某种形式的CAM，现在每年去CAM提供者的总次数超过了初级保健医生。据估计，有1500万成年人在服用处方药的同时服用草药或大剂量维生素。NCCAM研究以科学严谨的方式设计，并监测患者的产品使用情况。然而，测量生物标志物和代谢物将极大地提高数据的准确性和可靠性。NCCAM要求开发“用于生成和解释关于使用CAM和传统疗法的决策所需证据的通用方法、措施和标准”。Caldera制药公司将开发一种新技术，以客观评估患者对补充和替代药物(CAM)的使用情况。Caldera建议开发和优化技术，以最小的侵入性和客观的方式捕获在门诊和临床环境中以及从参与干预策略的一系列患者群体中对某些凸轮的依从性。Caldera预计，这些工具将与常用的矿物质补充剂(如吡啶甲酸铬、硫酸镁以及有机和无机硒)特别相关，但最终将解决与其他凸轮的粘附性问题。该项目将使用无试剂药物蛋白质组测量(RPM)，这是一种使用X射线荧光来量化金属与蛋白质结合的技术。RPM可用于鉴定和定量体液中具有生物活性的CAM制剂及其代谢物。Caldera将定制和优化其独特的RPM技术，以在CAM研究中具体衡量患者的依从性。第一阶段包括在酵母模型中使用RPM测量蛋白质的金属含量。第二阶段包括使用RPM来测量CAM依从性，使用现有的CAM临床试验的生物标本来对这项技术进行基准测试。超过三分之一的美国成年人报告使用某种形式的补充和替代药物(CAM)，现在每年去CAM提供者的总次数超过了初级保健医生。NCCAM要求开发通用方法来生成和解释做出关于使用CAM和传统疗法的决定所需的证据。Caldera制药公司将开发技术，客观地评估患者对使用CAM的依从性。

DESCRIPTION (provided by applicant): The use of dietary supplements has become increasingly popular in the US, and these supplements are not subject to stringent pre-marketing testing or post-marketing surveillance. More than a 1/3rd of American adults report using some form of CAM, with total visits to CAM providers each year now exceeding those to primary-care physicians. An estimated 15 million adults take herbal remedies or high-dose vitamins along with prescription drugs. NCCAM studies are designed in scientifically rigorous manners and patients are monitored for product usage. However, measuring biological markers and metabolites would greatly benefit the accuracy and reliability of data. NCCAM has requested the development of "common methods, measures, and standards for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies."Caldera Pharmaceuticals will develop a new technology to objectively assess patient adherence to the use of complementary and alternative medicines (CAMs). Caldera proposes to develop and optimize technology that will capture, in minimally invasive and objective ways, adherence to certain CAMs in ambulatory and clinical settings, and from a range of patient groups engaging in intervention strategies. Caldera anticipates that these tools will be particularly relevant to commonly used mineral supplements (such as chromium picolinate, magnesium sulfate, and organic and inorganic selenium), but will eventually address adherence to other CAMs. This project will use Reagentless Pharmacoproteomic Measurement (RPM), a technique that uses X-ray fluorescence to quantify the binding of metals to proteins. RPM can be used to identify and quantify biologically active CAM agents and their metabolites in body fluids. Caldera will tailor and optimize its unique RPM technology to specifically measure patient adherence in CAM studies. Phase I consists of using RPM to measure metal content of proteins in a yeast model. Phase II consists of using RPM to measure CAM adherence using biological specimens from existing CAM clinical trials to benchmark this technique. More than a 1/3rd of American adults report using some form of complementary and alternative medicines (CAM), with total visits to CAM providers each year now exceeding those to primary-care physicians. NCCAM has requested the development of common methods for the generation and interpretation of evidence necessary for making decisions about the use of CAM and conventional therapies. Caldera Pharmaceutical will develop technology to objectively assess patient adherence to the use of CAM.