Asymmetry in Scientific Method and Limits to Cross-Disciplinary Dialogue
Asymmetry in Scientific Method and Limits to Cross-Disciplinary Dialogue
复制标题
科学方法的不对称和跨学科对话的限制
DOI：
--
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发表时间：
2007
影响因子：
2.6
通讯作者：
T. Someya
中科院分区：
文献类型：
--
作者：
V. Ozdemir;B. Williams;J. Graham;S. Preskorn;Dimitrios Gripeos;S. Glatt;R. Friis;C. Reist;Sandor Szabo;J. Lohr;T. Someya
药物基因组学是人类疾病遗传学和临床药理学交叉的实验科学的混合领域，共享新的基因组技术的应用。但是这个混合领域还不稳定，也没有完全整合，药物基因组学的科学政策也没有完全准备好解决这个新兴混合领域的挑战。人类疾病遗传学和临床药理学学科在其科学实践中存在显著差异。临床药理学起源于一门实验科学，而人类疾病遗传学本质上主要是观察性的。其结果是科学方法的显著不对称，这可能会对基因-环境相互作用的识别程度产生不同的影响，进而影响每个学科所需的研究样本量。由于参加疾病观察性遗传研究的受试者数量通常被视为科学有效性和可靠性的重要标准，未能认识到特定学科对样本量的要求可能导致不恰当地驳回或沉默有价值的，尽管规模较小，采用实验研究设计的基于工艺的药物基因组学研究。重要的是，认识到药物基因组学是一门实验科学，为在药物获得监管批准之前前瞻性地追求基因定制疗法的伦理必要性创造了系统政策回应的途径。为此，我们讨论了医学科学、政策和社会科学之间跨学科参与的关键作用。我们强调需要在药物基因组学混合领域的科学、方法和社会伦理认识论分歧之间制定共享标准，以最好地服务于公共卫生的利益。
Pharmacogenomics is a hybrid field of experimental science at the intersection of human disease genetics and clinical pharmacology sharing applications of the new genomic technologies. But this hybrid field is not yet stable or fully integrated, nor is science policy in pharmacogenomics fully equipped to resolve the challenges of this emerging hybrid field. The disciplines of human disease genetics and clinical pharmacology contain significant differences in their scientific practices. Whereas clinical pharmacology originates as an experimental science, human disease genetics is primarily observational in nature. The result is a significant asymmetry in scientific method that can differentially impact the degree to which gene-environment interactions are discerned and, by extension, the study sample size required in each discipline. Because the number of subjects enrolled in observational genetic studies of diseases is characteristically viewed as an important criterion of scientific validity and reliability, failure to recognize discipline-specific requirements for sample size may lead to inappropriate dismissal or silencing of meritorious, although smaller-scale, craft-based pharmacogenomic investigations using an experimental study design. Importantly, the recognition that pharmacogenomics is an experimental science creates an avenue for systematic policy response to the ethical imperative to prospectively pursue genetically customized therapies before regulatory approval of pharmaceuticals. To this end, we discuss the critical role of interdisciplinary engagement between medical sciences, policy, and social science. We emphasize the need for development of shared standards across scientific, methodologic, and socioethical epistemologic divides in the hybrid field of pharmacogenomics to best serve the interests of public health.
新药的安全性：提出正确问题的重要性。
DOI：
10.1001/jama.281.18.1753
发表时间：
1999
期刊：
JAMA
影响因子：
--
作者：
Wood,AJ
通讯作者：
Wood,AJ