Optimizing Research Infrastructure of Registries to Accelerate Participant Recruitment into Alzheimer's Focused Studies

项目总结/摘要 阿尔茨海默病（AD）所造成的痛苦是我们这个时代最大的医学挑战之一。 随着紧迫感的增强，许多AD预防试验正在启动，需要一个 健康的老年人数量空前，需要进行筛查，以确定数千名有资格参加的人。 与此同时，在受影响的个人及其护理伙伴中进行的试验数量继续增加。在2019年， 有156项治疗AD的试验，比2018年有所增加。值得注意的是，这一数字不包括 观察性研究，这对了解AD和开发新的干预措施治疗AD也很重要。 改进参与者招募方法已成为外地的一个关键优先事项。举措 例如，国家应对AD计划呼吁更加关注增加临床试验的入组人数 和其他临床研究。国家计划的一个成果是国家征聘战略， 参与阿尔茨海默病临床研究，其中列举了四个目标，其中一个是重点 特别是需要“建立和改善登记册的研究基础设施， 越来越多的合格的研究参与者。”本提案的目标是开发、部署、 优化和自动化新的网站设计/内容，基础设施和功能，以支持和维持 在线招募、参与和保留有兴趣参与以AD为重点的研究的成年人， 为研究人员创造可持续和持久的资源。为了实现这一目标，我们将建立我们的 成功的阿尔茨海默氏症预防登记处（APR），一个在线登记处于2012年推出，有超过35万人 成员，其中约90，000人参加了2015年启动的GeneMatch（GM）计划，目标如下： 1)开发、部署、优化和自动化更新的可持续招聘网站平台 参与APR及其GM计划的成员; 2）开发，部署，优化和自动化 更新的网站平台，支持研究人员努力招募APR和GM成员;以及3）开发， 部署、优化和自动化新功能和流程，以便将APR和GM成员推荐给AD- 集中研究。我们假设a）更新后的网站将增加APR和GM的注册人数 以及成员的参与和保留; B）增强的AD研究人员经验将增加 利用APR/GM满足其参与者招募需求的研究人员/研究申办者数量， 允许他们更快地完成入组;以及c）新功能将增加APR的百分比， GM成员筛选并参与AD研究。

Project Summary/Abstract The suffering caused by Alzheimer's disease (AD) is one of the greatest medical challenges of our time. With a heightened sense of urgency, numerous AD prevention trials are being launched, requiring an unprecedented number of healthy older adults to be screened to identify the thousands eligible to participate. At the same time, the number of trials in affected individuals and their care partners continues to rise. In 2019, there were 156 trials for the treatment of AD, an increase from 2018. Notably, this number does not include observational studies, which are also important to understanding AD and developing new interventions to treat or prevent it. Improving participant recruitment methods has become a critical priority for the field. Initiatives such as the National Plan to Address AD call for greater attention to increasing enrollment into clinical trials and other clinical research. An outgrowth of the National Plan is the National Strategy for Recruitment and Participation in Alzheimer's Disease Clinical Research which enumerated four goals, one of which is focused specifically on the need to “build and improve research infrastructure of registries in order to recruit and retain more and more diverse qualified study participants.” The objective of this proposal is to develop, deploy, optimize and automate new website design/content, infrastructure and functionality to support and sustain online recruitment, engagement, and retention of adults interested in participating in AD-focused studies, creating a sustainable and enduring resource to researchers. To accomplish this, we will build off our successful Alzheimer's Prevention Registry (APR), an online registry launched in 2012 with >350,000 members, including ~90,000 enrolled in its GeneMatch (GM) program launched in 2015 via the following aims: 1) develop, deploy, optimize and automate a refreshed and sustainable website platform for the recruitment into and engagement of members in the APR and its GM program; 2) develop, deploy, optimize and automate a refreshed website platform supporting researchers' efforts to recruit APR and GM members; and 3) develop, deploy, optimize and automate new functionality and processes for referring APR and GM members to AD- focused studies. We hypothesize that the a) refreshed website will increase enrollment into the APR and GM as well as engagement and retention of members; b) enhanced AD-Researcher experience will increase the number of researchers / study sponsors leveraging the APR/GM for their participant recruitment needs, allowing them to complete enrollment faster; and c) new functionality will increase the percentage of APR and GM members screening for and enrolling in AD-focused studies.