SBIR Phase I: Creation of a virtual population of older, black patients with hypertension and comorbidities for improved treatment development

SBIR 第一阶段：创建患有高血压和合并症的老年黑人患者虚拟群体，以改善治疗开发

• 批准号: 2110147
• 负责人: William Pruett
• 金额: $ 23.7万
• 依托单位: HC Simulation, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2022-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2110147&HistoricalAwards=false
• 关键词: SBIR; Phase; Creation; virtual; population

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a tool that will streamline the clinical trial process, reducing time and money spent without sacrificing safety or an understanding of a treatment’s efficacy. Medical treatments do not work equally well on all patients. Finding a responsive population on which to perform a study directly impacts the likelihood of a new therapy’s success while minimizing risk to patients who would see little or no benefit. The tool will allow clinical trials to be run virtually as computer programs in software that simulates human physiology. This technology will be valuable at all stages of treatment development: suggesting new therapies, testing for adverse effect, planning clinical trials, interpreting trial results, and predicting results when a new therapy is introduced outside of the clinical trial. This project is focused initially on the development of a critical under-represented population: older black men with hypertension and associated diseases, including heart disease and diabetes. Simulations of specific populations will allow researchers and clinicians to anticipate issues, enabling more effective treatment plans.This Small Business Innovation Research (SBIR) Phase I project will develop a virtual population of 50-70 year old hypertensive African-American men with and without common cardiovascular comorbidities including congestive heart failure and type II diabetes. The virtual patients will be instantiations of a differential-algebraic model of human physiology, reflecting interactions between factors such as hormone concentrations, electrolytes, and more. The virtual population will be generated from clinical data collected from other studies and the approach can be used for other specific populations who may be historically under-represented in trials. This model can be used to estimate responses to clinical interventions (device and pharmaceutical therapies) to inform treatment development and further trials.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是一种工具，它将简化临床试验过程，减少时间和金钱的消费而不牺牲安全性或对治疗有效性的理解。医疗治疗对所有患者的工作效果均不错。找到进行研究的反应人群直接影响新疗法成功的可能性，同时最大程度地减少对几乎没有收益的患者的风险。该工具将允许在模拟人类生理学的软件中实际上作为计算机程序进行临床试验。在治疗开发的所有阶段，这项技术将是有价值的：建议新疗法，测试不良反应，计划临床试验，解释试验结果以及在临床试验之外引入新疗法时预测结果。该项目最初集中于关键代表性不足的人群的发展：患有高血压和相关疾病的老年黑人，包括心脏病和糖尿病。对特定人群的模拟将使研究人员和临床医生能够预见问题，从而实现更有效的治疗计划。本小型企业创新研究（SBIR）I期项目将发展具有50至70年历史的50-70岁高血压非洲裔美国人的虚拟人群，具有和没有常见的心血管疾病，包括会充血性心力衰竭和II型糖尿病。虚拟患者将是人类生理学差异代数模型的实例化，这反映了诸如赛酮浓度，电解质等因素之间的相互作用。虚拟人群将从其他研究中收集的临床数据中产生，该方法可用于其他特定人群，这些特定人群历史上可能在试验中代表不足。该模型可用于估计对临床干预措施（设备和药物疗法）的反应，以告知治疗开发和进一步的试验。该奖项反映了NSF的法定任务，并通过使用基金会的智力优点和更广泛的影响评估标准，认为通过评估来获得珍贵的支持。