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

该提案支持于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。讲习班的重点是将计算和工程领域的领导者与生物医学领域的领导者聚集在一起，为临床试验背景下的数字卫生技术的未来制定路线图。需要该研讨会来评估与临床试验相关的数字技术科学状况和研究差距领域。对数字技术在审判中的期望应该使国家受益：1)通过简化审判的进行来提高效率；2)增加研究参与者参与试验的机会；3)降低进行试验的成本；4)提高研究数据质量；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影响，从而将新的治疗和/或干预措施转变为医疗实践的能力，而且还具有丰富的令人兴奋的计算和工程挑战。提议的研讨会将汇集来自计算和工程领域的专家与来自生物医学临床试验领域的专家，以寻找共同的工作，共同的语言和研究路线图，以实现有效的协作，为数字临床试验创造更美好的未来。最有用的尖端数字卫生技术最终需要这些社区制定一项联合计划，这些社区通常不会在一起讨论，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影响，从而将新的治疗和/或干预措施转变为医疗实践的能力，而且还具有丰富的令人兴奋的计算和工程挑战。例如，基于传感器反馈的个性化或适应性试验的概念将需要新的传感系统和控制算法，以及对疾病过程中涉及的潜在生理/生物系统的更好理解。因此，这次研讨会将把那些正在建立新方法和工具的人与那些将使用它们为这些不同研究小组的未来制定研究计划的人聚集在一起。该奖项反映了美国国家科学基金会的法定使命，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。

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.