Pharmacogenetic Testing: Challenges of Clinical Integration

药物遗传学测试：临床整合的挑战

• 批准号: 7684219
• 负责人: Susanne B Haga
• 金额: $ 39.47万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-05 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7684219
• 关键词: Address; Adopted; Adverse effects; Alzheimer' s disease risk; Area; Attitude; Bioethics; Caring; Clinical; Clinical Practice Guideline; Communication; Consensus; Counseling; Data; Development; Disclosure; Disease; Early Diagnosis; Ensure; Ethics; Focus Groups; General Population; Genetic; Genetic Counseling; Genetic Predisposition to Disease; Genetic screening method; Genomics; Health; Health Personnel; Health Professional; Hybrids; Informed Consent; Intervention; Laws; Lead; Legal; Legal Obligations; Macular degeneration; Maps; Medical; Medicine; Negligence; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacogenetics; Pharmacotherapy; Policies; Population; Predisposition; Professional counselor; Property; Provider; Public Health; Reporting; Research; Research Infrastructure; Review Literature; Risk; Risk Reduction; Role; Severity of illness; Surveys; System; Test Result; Testing; United States; base; case-based; clinical application; clinical practice; clinically relevant; court; disorder risk; drug efficacy; expectation; improved; interest; outcome forecast; pharmacogenetic testing; population based; preference; public health relevance; response; social implication; standard of care; working group

DESCRIPTION (provided by applicant): Pharmacogenetic testing is considered one of the most promising clinical applications arising from genomics research, with the potential to reduce adverse drug responses and improve efficacy of drug treatment. Because pharmacogenetic tests address a specific question about drug therapy, they have generally been viewed as having fewer ethical and social implications than other types of genetic testing. Yet some policy concerns will need to be addressed before pharmacogenetic tests can be introduced appropriately into clinical practice. A key concern is the potential for pharmacogenetic tests to generate ancillary clinical information unrelated to the drug treatment question for which testing is done - an informational "side effect." The ancillary information generated by pharmacogenetic tests is variable, and may include information about disease predispositions, prognosis, and drug responses other than those for which testing is performed. For example, testing for statin response might reveal information about risk of Alzheimer's disease or macular degeneration. These issues raise several questions: What would a reasonable person want to know about the scope of testing and access to test results? Should information about other potential uses of a test result be made available to the patient? Which health care professionals should routinely have access to pharmacogenetic results? This project will explore these policy challenges through the following specific aims: 1) determine the legal obligations of health professionals with respect to sharing of pharmacogenetic information and disclosure of ancillary clinical information; 2 & 3) assess attitudes of the public and health professionals toward disclosure of different types of ancillary information related to pharmacogenetic testing and related issues of informed consent, counseling, and sharing of pharmacogenetic information among health professionals through focus groups and surveys, and 4) develop a stakeholder consensus regarding appropriate policies for counseling, informed consent and disclosure of ancillary information related to pharmacogenetic testing. PUBLIC HEALTH RELEVANCE - The results of this study will help to ensure the appropriate clinical integration of pharmacogenetic testing, and inform related issues arising with the increasing use of genetic testing for the general population, including risk communication and the appropriate roles of health professionals as we enter the era of genomic medicine in the US. This study will also help inform determinations of whether new health infrastructures for pharmacogenetics are required beyond current systems for successful population-wide integration.

描述（由申请人提供）：药物遗传学测试被认为是基因组研究引起的最有希望的临床应用之一，有可能减少药物不良反应并提高药物治疗的功效。由于药物遗传学测试解决了有关药物疗法的特定问题，因此通常被视为与其他类型的基因检测相比，它们具有更少的道德和社会意义。然而，在将药物遗传学测试适当地引入临床实践之前，需要解决一些政策问题。一个关键问题是药物遗传学测试的潜力产生与进行哪个测试的药物治疗问题无关的辅助临床信息 - 信息“副作用”。药物遗传学测试产生的辅助信息是可变的，可能包括有关疾病易感性，预后和药物反应的信息，而不是进行测试的信息。例如，对他汀类药物反应的测试可能会揭示有关阿尔茨海默氏病或​​黄斑变性风险的信息。这些问题提出了几个问题：一个合理的人想了解测试范围和访问测试结果的范围吗？是否应该向患者提供有关测试结果其他潜在用途的信息？哪些医疗保健专业人员应该常规获得药物遗传学结果？该项目将通过以下特定目的探讨这些政策挑战：1）确定卫生专业人员在共享药物遗传信息方面的法律义务并披露辅助临床信息； 2＆3）评估公共和卫生专业人员对披露与药物遗传学测试以及相关问题有关的不同类型的辅助信息以及知情同意，咨询以及通过焦点小组和调查中的药物遗传学信息的相关问题以及相关的相关问题的态度，以及4）4）在咨询中开发有关适当的咨询的利益相关者，以培养有关咨询的相关性，以供应提供了相关性的促进，并提供了相关信息。公共卫生相关性 - 这项研究的结果将有助于确保药物遗传学测试的适当临床整合，并为对普通人群的基因测试的使用日益增加而引起的相关问题，包括风险交流和我们进入美国基因组医学时代的适当作用。 这项研究还将有助于确定是否需要在当前成功整体整合的系统之外，是否需要新的针对药物遗传学的健康基础设施。