Preemptive pharmacogenetic testing in medically underserved populations

项目总结 先发制人的药物遗传学(PGx)测试可能对医疗服务不足特别有益 通过减少优化药物治疗所需的预约数量并增加 价格较低的非专利药物的有效性--这是药物遗传学指南中最常见的类型 可用(PGx药物)。然而，几乎没有数据可用于指导这些患者的临床实施 人口。我们的长期目标是为将PGx有效地应用于临床做出贡献 实践提高用药处方的精准度。此应用程序的总体目标是 确定医疗服务不足患者的PGx药物使用模式，并评估其可行性和 先发制人的PGx检测在这一患者群体中的有效性。中心假设是在医学上 服务不足的患者开出更多的PGx药物，先发制人的PGx测试是可行的 有效地提高了患者的用药满意度。建议进行这项研究的理由是 确定最能从PGx测试中受益的患者群体将有助于临床实施 可能会减少药物治疗的差异。 我们计划测试中心假设，并通过以下方式实现此应用程序的总体目标 三个具体目标。第一个目标是确定相关的临床、人口和社会经济因素。 在一个庞大的、真实的、多样化的患者群体中使用PGx药物处方模式。我们会做到这一点的 目的通过将临床、人口学和社会经济数据与数百万 佛罗里达州的病人。第二个目标是开发一种低成本、包含祖先的PGx测试 为告知常用的PGx药物而设计的小组。我们将设计一种低成本、经临床验证的面板 将包括在美国少数族裔中常见的变异。我们计划利用广泛的批次测试 以及已经可用的基因分型平台，该平台将劳动力成本降至最低，以实现显著的成本 积蓄。第三个目标是确定低成本预防性PGx测试在医学上的可行性 服务不足人群及其对患者用药满意度的影响。我们将通过以下方式实现这一目标 完成一项随机开放标签临床试验，比较接受医疗服务不足的患者 对那些接受常规护理的人进行先发制人的PGx检测。我们将比较关键实施指标，并将 还在患者和医疗保健提供者中进行半结构化访谈，以评估对PGx的看法 来自利益攸关方的可行性和可持续性。 这项拟议的研究具有重要意义，因为它应该为这两项研究提供有价值的初步数据 先发式PGx测试的现实有效性及其研究和实施的可行性 这项技术适用于医疗服务不足的患者--这是PGx研究的一个领域，几乎没有数据可用。这个 拟议的研究是创新的，因为这个项目将利用额外的人口和社会经济 与临床数据一起，应该能更好地识别最有可能从PGx中受益的患者群体 测试并允许有重点地对这些人群进行实施工作。最终，我们希望拥有 开发了有价值的数据，确定了最有可能从先发制人的PGx测试中受益的患者，特别是在 医疗服务不足的患者和/或少数族裔成员。这些结果应该有一个 重要的积极影响，因为它们可以为PGx的进一步临床实施工作以及 未来先发制人测试的大型临床试验，理想地减少精确度领域的医疗差距 医药。

PROJECT SUMMARY Preemptive pharmacogenetic (PGx) testing may be particularly beneficial in medically underserved populations by reducing the number of appointments required to optimize drug therapy and increasing the effectiveness of less expensive off-patent medications – the type most often with pharmacogenetic guidelines available (PGx drugs). However, there is little data available to guide clinical implementation in these patient populations. Our long-term goal is to contribute toward the efficient implementation of PGx into clinical practice to improve the precision of medication prescribing. The overall objective for this application is to identify PGx drug usage patterns in medically underserved patients, and assess the feasibility and effectiveness of preemptive PGx testing in this patient population. The central hypothesis is that medically underserved patients are prescribed more PGx drugs, and preemptive PGx testing is feasible as well as effective in improving patient medication satisfaction. The rationale for the proposed research is that identifying patient populations that can most benefit from PGx testing will facilitate clinical implementation that may reduce medication treatment disparities. We plan to test the central hypothesis and accomplish the overall objective of this application by pursuing three specific aims. The first aim is to identify clinical, demographic and socioeconomic factors associated with PGx drug prescribing patterns in a large, real-world, diverse patient population. We will accomplish this aim by comparing clinical, demographic, and socioeconomic data with prescription data from millions of patients across the State of Florida. The second aim is to develop a low-cost, ancestrally inclusive PGx testing panel designed to inform commonly used PGx drugs. We will design a low-cost, clinically validated panel that will include variants common in racial minorities in the U.S. We plan to leverage extensive batching of tests and an already available genotyping platform that minimizes labor costs in order to achieve significant cost savings. The third aim is to determine the feasibility of low-cost preemptive PGx testing in a medically underserved population as well as its effect on patient medication satisfaction. We will accomplish this aim by completing a randomized open-label clinical trial comparing medically underserved patients receiving preemptive PGx testing to those receiving usual care. We will compare key implementation metrics and will also conduct semi-structured interviews in both patients and healthcare providers to assess PGx perceptions of feasibility and sustainability from stakeholders. The proposed research is significant because it should contribute valuable preliminary data toward both the real-world effectiveness of preemptive PGx testing as well as the feasibility of studying and implementing this technology in medically underserved patients – an area of PGx research where few data are available. The proposed research is innovative because this project will utilize additional demographic and socioeconomic data that, with along with clinical data, should better identify patient populations most likely to benefit from PGx testing and allow focused of implementation efforts to those populations. Ultimately, we expect to have developed valuable data identifying patients most likely to benefit from preemptive PGx testing, particularly in patients who are medically underserved and/or members of racial minorities. These results should have an important positive impact because they can inform further clinical implementation efforts of PGx as well as future large clinical trials of preemptive testing, ideally reducing healthcare disparities in the field of precision medicine.