Preemptive pharmacogenetic testing in medically underserved populations

在医疗服务不足的人群中进行先发性药物遗传学检测

基本信息

批准号：
10228297
负责人：
Julio David Duarte
金额：
$ 75万
依托单位：
UNIVERSITY OF FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10228297
关键词：
Academic Medical Centers Address Affect African American Appointment Area Clinical Clinical Data Clinical Trials Cost Savings Data Demographic Factors Disease Drug Prescriptions Effectiveness Ensure Feasibility Studies Florida Future Genetic Variation Genotype Geography Goals Guidelines Health Health Personnel Health Technology Health system Human Human Resources Insurance Carriers Interview Minority Groups Mission Outcome Patient-Focused Outcomes Patients Pattern Perception Pharmaceutical Preparations Pharmacogenetics Pharmacotherapy Population Primary Health Care Race Randomized Research Socioeconomic Factors Structure Technology Testing Underserved Population United States National Institutes of Health Variant base care outcomes clinical care clinical implementation clinical practice cost design disparity reduction health care disparity health care quality implementation efforts improved innovation innovative technologies medically underserved medically underserved population member new technology off-patent open label patient population pharmacogenetic testing precision drugs precision medicine prevent programs racial minority response satisfaction socioeconomics treatment as usual treatment disparity trial comparing willingness to pay

项目摘要

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.

项目摘要先发制人药物遗传学（PGX）测试可能在医学欠佳的情况下特别有益人口通过减少优化药物治疗所需的约会数量并增加较便宜的非适应性药物的有效性 - 这种类型通常使用药物遗传学指南可用（PGX药物）。但是，几乎没有数据可指导这些患者的临床实施人群。我们的长期目标是为有效实施PGX贡献练习以提高药物处方的精度。该应用程序的总体目标是在医疗服务不足的患者中识别PGX药物使用模式，并评估可行性和先发制人PGX测试在该患者人群中的有效性。中心假设是医学上服务不足的患者处方更多的PGX药物，而先发制人的PGX测试是可行的，并且有效提高患者药物满意度。拟议研究的理由是确定可以从PGX测试中最大受益的患者人群将有助于临床实施可能会减少药物治疗分布。我们计划通过追求来检验中心假设并实现本应用的整体目标三个具体目标。第一个目的是确定相关的临床，人口和社会经济因素在大型现实世界中，使用PGX药物处方模式。我们将实现这一目标通过将临床，人口统计和社会经济数据与数百万的处方数据进行比较整个佛罗里达州的患者。第二个目的是开发低成本，祖先包含的PGX测试旨在告知常用PGX药物的面板。我们将设计一个低成本，临床验证的面板将包括美国种族少数群体常见的变体，我们计划利用大量测试以及已经可用的基因分型平台，可将人工成本降至最低，以实现巨大的成本储蓄。第三个目的是确定医学上低成本先发制人PGX测试的可行性服务不足的人群及其对患者药物满意度的影响。我们将通过完成一项随机开放标签临床试验，比较接受医学欠缺的患者对接受常规护理的人进行先发制人的PGX测试。我们将比较关键实施指标，并将还对患者和医疗保健提供者进行了半结构化访谈，以评估PGX感知利益相关者的可行性和可持续性。拟议的研究很重要，因为它应该为两者贡献有价值的初步数据先发制人PGX测试的现实有效性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中 - PGX研究的领域很少有数据。这拟议的研究具有创新性，因为该项目将利用其他人口统计和社会经济与临床数据一起，该数据应更好地识别最有可能从PGX中受益的患者人群测试并允许对这些人群进行实施工作。最终，我们希望有开发了有价值的数据，识别最有可能受益于先发制人PGX测试的患者，尤其是在少数族裔的医学服务不足和/或成员的患者。这些结果应该有一个重要的积极影响，因为他们可以为PGX以及未来的大型临床试验预先测试，理想地减少了精确领域的医疗保健分布药品。