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

这一小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种工具，将简化临床试验过程，减少时间和金钱，而不牺牲安全性或对治疗疗效的理解。药物治疗并不是对所有患者都同样有效。找到一个对研究有反应的人群直接影响新疗法成功的可能性，同时最大限度地降低患者的风险，这些患者几乎看不到或根本看不到任何益处。该工具将允许临床试验在模拟人体生理学的软件中以计算机程序的形式虚拟运行。这项技术在治疗开发的所有阶段都很有价值：建议新疗法，测试不良反应，规划临床试验，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。 该项目最初的重点是发展一个重要的代表性不足的人口：患有高血压和相关疾病，包括心脏病和糖尿病的老年黑人男子。对特定人群的模拟将使研究人员和临床医生能够预测问题，从而制定更有效的治疗计划。这一小型企业创新研究（SBIR）第一阶段项目将开发一个虚拟人群，该人群为50-70岁的高血压非裔美国男性，有或没有常见的心血管合并症，包括充血性心力衰竭和II型糖尿病。虚拟患者将是人体生理学微分代数模型的实例，反映激素浓度、电解质等因素之间的相互作用。 虚拟人群将根据从其他研究中收集的临床数据生成，该方法可用于其他特定人群，这些人群可能在试验中历史上代表性不足。 该模型可用于评估临床干预（器械和药物治疗）的反应，为治疗开发和进一步试验提供信息。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.