FDA real-world evidence to be made available on Google Cloud


2020-01-09 11:05:29 Healthcareitnews


Google announced this week that it will make the U.S. Food & Drug Administration's open-source MyStudies platform available on the Google Cloud Platform. WHY IT MATTERS The goal, said Jameson Rogers, product manager at Google Cloud Healthcare & Life Sciences, is "stimulate an open ecosystem that will improve the ability of organizations to perform research that leads to better patient outcomes. FDA's ongoing prioritization of real-world evidence means that "drug and device organizations are increasingly looking to incorporate patient-generated data into regulatory submissions for new products and treatment indications," as Rogers explained in a blog post. To help researchers manage and submit that vast and disparate data, in a secure and compliant manner, FDA developed the open-source MyStudies – a platform aimed at helping drug, biologic and device organizations with the collecting and reporting of real-world data for regulatory submissions. Rogers said Google Cloud is working to expand the MyStudies platform with new security and configurable privacy controls, offering the the ability for research organizations to detect and personally identifying information. That means, he said, that "when an organization deploys FDA MyStudies on Google Cloud, a unique and logically isolated instance of the platform is created that only that organization and its delegates are authorized to access." This in turn will "allow a research organization to select which of its researchers and clinicians are able to access what data, and to help optimize the use of that data as directed by participants," said Rogers. "By leveraging Google Cloud as the underlying infrastructure for their FDA MyStudies deployments, organizations will have more safeguards in the ownership and management of data in their studies." THE LARGER TREND As part of the initiative, Google will bring MyHeart Counts, a cardiovascular research study run by Stanford University, onto the FDA's platform. So far, that project has enrolled more than 60,000 participants and enabled deeper understanding of the feasibility of conducting large-scale, smartphone-based clinical trials, Rogers notes. "Once enrolled, participants are asked survey questions related to their health and physical activity," he explained. "Participants may allow MyHeart Counts to collect physical activity data from their phone and other wearable devices. If participants are physically able, they will be asked to perform a 6-minute walk test, then enter information about risk factors and blood tests, which is used to determine a cardiovascular risk score." Until now, however, those participants were all iOS users: MyHeart Counts was launched in 2015 as part of the first groups of iOS research apps. But by enabling its availability through MyStudies, Google Cloud will help researchers expand their insights by enabling enrollment of both Android and iOS users. ON THE RECORD "Consistent with our obligations under the 21st Century Cures Act, FDA engages in public-private demonstration projects to advance the regulatory science around real-world evidence," explained Dr. David Martin, associate director for real-world evidence analytics at FDA's Office of Medical Policy. "The Patient Centered Outcomes Research Trust Fund investment that launched FDA MyStudies is a step toward this goal." While FDA MyStudies is publicly available, "it requires professional expertise and time to progress from open-source resources to deployment of a new re-branded platform," he said. "Google Cloud is taking these resources and creating a click-to-deploy option linked to additional health data management and analytics." "MyHeart Counts and digital apps like it allow experts to connect directly to patients in a way that’s more immediate and more extensive, through direct, sensor-based measurement collection," said Euan Ashley, professor of medicine, of genetics and of biomedical data science at Stanford. "Google Cloud’s support of these efforts not only helps researchers organize and deploy important research programs faster and more reliably, but ultimately will help patients and doctors notice health issues early, so they can address them sooner."
谷歌本周宣布,将在谷歌云平台上提供美国食品和药物管理局的开源 MyStudies 平台。 什么是IT问题 GoogleCloudHealthcare & Life Sciences 的产品经理 JamesonRogers 说,这个目标是“刺激一个开放的生态系统,它将提高组织进行研究的能力,从而带来更好的患者结果。 正如罗杰斯在博客中解释的那样, FDA 对真实世界证据的优先排序意味着“药物和设备组织越来越多地寻求将患者产生的数据纳入新产品和治疗适应症的监管提交中”。 为了帮助研究人员以安全和合规的方式管理和提交大量不同的数据, FDA 开发了开源 MyStudies 平台,旨在帮助药物、生物和设备组织收集和报告真实世界的数据,以供监管机构提交。 罗杰斯说,谷歌云正致力于通过新的安全和可配置的隐私控制扩展 MyStudies 平台,为研究组织提供检测和个人识别信息的能力。 他说,这意味着“当一个组织部署了 FDA 对 GoogleCloud 的 MyStudies 时,创建了一个独特且逻辑上独立的平台实例,只有该组织及其代表才有权访问。” 这反过来将“允许一个研究组织选择它的研究人员和临床医生能够访问什么数据,并帮助优化使用该数据的指导,由参与者,”罗杰斯说。“通过利用 GoogleCloud 作为 FDA MyStudies 部署的基础架构,组织将在其研究中拥有和管理数据方面拥有更多保障。” 研资局局长 作为该计划的一部分,谷歌将把斯坦福大学进行的心血管研究 MyHeart Counts 带到 FDA 的平台上。罗杰斯指出,到目前为止,该项目已吸引了超过6万名参与者,并使人们更深入地了解开展大规模基于智能手机的临床试验的可行性。 他解释说:“一旦被录取,参与者就会被问及与他们的健康和身体活动有关的调查问题。”“参与者可以允许 MyHeart Counts 从他们的手机和其他可穿戴设备中收集体育活动数据。如果参与者身体上有能力,他们将被要求进行6分钟的步行测试,然后输入有关风险因素和血液测试的信息,这些信息用于确定心血管风险评分。” 然而,到目前为止,这些参与者都是 iOS 用户: MyHeart Counts 是作为 iOS 研究应用第一组的一部分于2015年推出的。但是,通过 MyStudies 实现其可用性, GoogleCloud 将帮助研究人员通过注册 Android 和 iOS 用户来扩展他们的洞察力。 记录上的 FDA 医学政策办公室负责真实世界证据分析的副主任 David Martin 博士解释说:“与我们在《21世纪治愈法案》中的义务相一致, FDA 参与了公共和私人的示范项目,以推动监管科学的真实世界证据。”“以病人为中心的成果研究信托基金投资启动了 FDA 的研究是朝着这个目标迈出的一步。” 他说,虽然 FDA 的 MyStudies 是公开的,“但从开源资源到部署一个新的品牌平台,需要专业的专业知识和时间。”“谷歌云正在利用这些资源,并创建一个与其他健康数据管理和分析相关的点击部署选项。” 斯坦福大学遗传学和生物医学数据科学医学教授 EuanAshley 说:“ MyHeart Counts 和类似的数字应用程序允许专家通过基于传感器的直接测量收集,以更直接、更广泛的方式与患者直接联系。”“谷歌云对这些努力的支持不仅帮助研究人员更快、更可靠地组织和部署重要的研究项目,而且最终将帮助患者和医生及早发现健康问题,从而更快地解决这些问题。”