Preemptive pharmacogenetic testing in medically underserved populations

项目摘要 先发制人的药物遗传学（PGx）测试可能是特别有益的医疗服务不足， 通过减少优化药物治疗所需的预约次数， 较便宜的非专利药物的有效性-最常见的药物遗传学指南类型 PGx药物（PGx drugs）然而，很少有数据可用于指导这些患者的临床实施 人口。我们的长期目标是促进PGx在临床上的有效实施。 实践，以提高药物处方的准确性。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，并评估可行性， 在该患者人群中进行先行PGx检测的有效性。核心假设是， 服务不足的患者被开更多的PGx药物，先发制人的PGx检测是可行的， 提高患者用药满意度。拟议研究的理由是， 确定最能从PGx检测中获益的患者人群将促进临床实施， 可以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本申请的总体目标 三个具体目标。第一个目的是确定临床，人口统计学和社会经济因素相关 PGx药物处方模式在一个大的，现实世界中，不同的患者人群。我们会完成的 通过比较临床，人口统计学和社会经济数据与数百万人的处方数据， 佛罗里达州的病人。第二个目标是开发一种低成本的，包括祖先的PGx检测 旨在告知常用PGx药物的面板。我们将设计一个低成本的，经过临床验证的面板， 将包括在美国少数民族中常见的变异。我们计划利用广泛的测试 以及已经可用的基因分型平台，其最小化劳动力成本以实现显著的成本 积蓄第三个目的是确定低成本的先发制人PGx检测在医学上的可行性。 服务不足的人群以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， 对那些接受常规治疗的人进行先发制人的PGx检测。我们将比较关键的实施指标， 还对患者和医疗保健提供者进行半结构化访谈，以评估PGx的看法 的可行性和可持续性。 拟议的研究是重要的，因为它应该为这两个方面提供有价值的初步数据。 先发制人的PGx测试的实际效果以及研究和实施的可行性 这项技术在医疗服务不足的患者-PGx研究的一个领域，很少有数据可用。的 拟议的研究是创新的，因为该项目将利用额外的人口和社会经济 数据，连同沿着临床数据，应更好地识别最有可能从PGx中获益的患者人群 测试，并使执行工作的重点放在这些人口。最终，我们希望 开发了有价值的数据，确定最有可能从先发制人的PGx检测中受益的患者，特别是在 医疗服务不足的患者和/或少数民族成员。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提供信息， 未来的大型临床试验的先发制人的测试，理想地减少医疗保健领域的差距， 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.