Workshop on Digital Clinical Trials: Brainstorming the Future for How Digital Health Technologies Can Impact Health and Wellness

该提案支持2019年4月1日至2日举行的数字临床试验研讨会，该研讨会由美国国立卫生研究院(NIH)的项目官员共同组织。研讨会的重点是将计算和工程领域的领导者与生物医学领导者聚集在一起，在临床试验的背景下为数字健康技术的未来创建路线图。研讨会是为了评估数字技术科学的状况以及与临床试验相关的研究空白领域。对试验中数字技术的期望将使国家受益：1)通过简化试验进行来提高效率；2)增加试验参与者的机会；3)降低进行试验的成本；4)提高研究数据的质量；以及5)增加个性化、适应性试验。这些重点领域不仅可以对临床试验产生变革性的影响，从而能够将新的治疗方法和/或干预措施转化为医疗实践，而且还充满了令人兴奋的计算和工程挑战。拟议的研讨会将把来自计算和工程领域的专家与来自生物医学临床试验世界的专家聚集在一起，寻找共同的工作、共同语言和研究路线图，以实现有效的合作，为数字临床试验创造更美好的未来。最有用的尖端数字医疗技术最终需要由这些社区制定联合计划，这些社区通常不会一起交谈，也不会参加类似的会议，也不会阅读相同的学术文献。这些重点领域不仅可以对临床试验产生变革性的影响，从而能够将新的治疗方法和/或干预措施转化为医疗实践，而且还充满了令人兴奋的计算和工程挑战。例如，基于传感器反馈的个人化或改编试验的概念需要新颖的传感系统和控制算法，并更好地了解疾病过程中涉及的基本生理/生物系统。因此，这次研讨会将把那些正在构建新方法和工具的人与那些将使用它们来为这些不同研究小组的未来创建研究计划的人聚集在一起。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

This proposal supports a Digital Clinical Trials workshop on April 1-2, 2019, co-organized the program officers from the National Institutes of Health (NIH). The workshop is focused on bringing together leaders in computing and engineering with biomedical leaders to create a roadmap for the future of digital health technologies in the context of clinical trials. The workshop is needed to evaluate the state of the science of digital technologies and research gap areas related to clinical trials. Expectations of digital technology in trials should benefit the country by: 1) Increasing efficiency by streamlining the conduct of trials; 2) Increase access to research participants in trials; 3) Decrease the cost of conducting trials; 4) Increase the quality of research data; and 5) Increase personalized, adaptive trials. These areas of focus not only can have transformative impact on clinical trials and thus the ability to transition new treatments and / or interventions into medical practice, but also are rich with exciting computing and engineering challenges. The proposed workshop will bring together experts from the computing and engineering fields with those from the biomedical clinical trials world to find common work, a common language, and a research roadmap to enable effective collaboration towards a better future for digital clinical trials. Cutting edge digital health technology that will be most useful ultimately needs a joint plan developed by these communities, who normally do not talk together nor attend similar conferences nor read the same academic literature. These areas of focus not only can have transformative impact on clinical trials and thus the ability to transition new treatments and / or interventions into medical practice, but also are rich with exciting computing and engineering challenges. For example, the concept of personalization or adaptation of trials based on sensor-feedback would require novel sensing systems and control algorithms, and a better understanding of the underlying physiological / biological systems involved in the disease process. Thus, this workshop will bring together those who are building new methods and tools with those who will use them to create a research plan for the future of these diverse research groups.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.