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Alphabet and Apple Take Divergent Paths in Health

Drug companies bet technology can revolutionise the $65bn market for clinical trials

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Apple had mixed results from a study designed to show that its Apple Watch could be used to detect heart problems. Photo: Noah Berger/Getty Images
苹果公司的研究结果好坏参半,旨在证明其Apple Watch可用于检测心脏问题。照片:Noah Berger / Getty Images

By Hannah Kuchler

Apple and Alphabet, two of the world's largest technology companies, are taking divergent approaches in their efforts to revolutionise healthcare, as doctors, drug companies and regulators look to Silicon Valley to bring down the cost of clinical trials.
全球最大的两家科技公司Apple和Alphabet正在采取不同的方法来改革医疗保健,因为医生,制药公司和监管机构希望硅谷降低临床试验的成本。

After Apple presented mixed results from a study designed to show that its Apple Watch could be used to detect heart problems, Verily --- like Google, a subsidiary of Alphabet --- has been opening up about its own effort to bring scientific rigour to the use of wearable devices for diagnosing health problems and testing treatments.
苹果公司在一项旨在表明其Apple Watch可用于检测心脏问题的研究中得出的结果不一样,Verily ---就像Google的子公司 - 已经开放了自己的努力,将科学的严谨性带到了使用可穿戴设备诊断健康问题和测试治疗。

Jessica Mega, Verily's chief medical officer, told the Financial Times that it was at an "inflection point" in the ability to store and process massive amounts of information that could transform clinical trials --- and ultimately, how much we understand about human biology.
Verily的首席医疗官Jessica Mega告诉英国"金融时报",它正处于存储和处理可能改变临床试验的大量信息的能力的"拐点" - 最终,我们对人体生物学了解多少。

The cardiologist and former clinical trial investigator said wearables such as Verily's Study Watch can collect far more data than could ever be found inside the "four walls of a clinic", discovering far more by measuring participants continuously.
心脏病专家和前临床试验研究员表示,像Verily的研究观察这样的可穿戴设备可以收集的数据远远超过"诊所的四面墙"内的数据,通过持续测量参与者发现了更多的数据。

"Currently we have a few gigabytes per person of health data --- that's projected to be terabytes in the future. We need to think about rigorous studies to figure out what signals matter," she said.
"目前我们每人的健康数据只有几千兆字节 - 未来预计会有太字节数。我们需要考虑严谨的研究来确定哪些信号很重要,"她说。

Unlike the Apple Watch, Verily's Study Watch is designed specifically for trials and is given to participants by trial organisers.
与Apple Watch不同,Verily的Study Watch专为试验而设计,由试用组织者提供给参与者。

Verily recently expanded its Project Baseline initiative, a partnership with Duke University and Stanford Medicine, which is collecting health data on more than 10,000 people using the Study Watch, as well as traditional methods, to discover clues that can predict disease. Now, in partnership with the American Heart Association, it is opening up a registry of women, often under-represented in research, who want to participate in clinical trials and test new technologies.
Verily最近扩大了项目基线计划,与杜克大学和斯坦福医学公司合作,该公司正在使用研究观察以及传统方法收集超过10,000人的健康数据,以发现可以预测疾病的线索。现在,它与美国心脏协会合作,开放了一个女性登记处,她们通常在研究中代表性不足,希望参与临床试验和测试新技术。

Large tech companies and start-ups are competing to revolutionise a clinical trials market that is worth $65bn, according to CB Insights. Trials are almost always essential for regulatory approval of new treatments, yet the process can take an average of 7.5 years and cost up to $2bn per drug, according to the research firm.
据CB Insights称,大型科技公司和初创企业正在争夺一个价值650亿美元的临床试验市场。研究公司表示,试验对于新疗法的监管批准几乎总是必不可少的,但这个过程平均需要7。5年,每种药物的成本高达20亿美元。

Even regulators such as the US Food and Drug Administration, which have stringent requirements on how trials are conducted, are pushing for more collaboration and data sharing, and the adoption of new technologies.
甚至美国食品和药物管理局等监管机构也对如何进行试验提出了严格的要求,这些监管机构正在推动更多的协作和数据共享以及采用新技术。

Scott Gottlieb, the outgoing FDA commissioner, said last month that "important therapeutic opportunities" risk being delayed or discarded because companies cannot afford to run the trials to validate them.
即将离任的FDA专员斯科特·戈特利布上个月表示,"重要的治疗机会"可能会被推迟或放弃,因为公司无力承担试验来验证它们。

"If you're a physician working on a clinical trial your experience is probably no different than 20 or 30 years ago," said Gary Hughes, chief executive of Teckro, a software platform that tries to make the process of participating in trials easier for doctors and patients. "It's still a people and paper process."
"如果你是一名从事临床试验的医生,你的经历可能与20或30年前没有什么不同,"Teckro的首席执行官Gary Hughes说道,Teckro是一个软件平台,试图让参与试验的过程变得更容易医生和病人。 "它仍然是一个人和纸过程。"

Teckro raised $25m from investors including Peter Thiel's Founders Fund in February.
Teckro在2月份从投资者那里筹集了2500万美元,其中包括Peter Thiel的创始人基金。

In an effort to reduce costs, pharmaceutical and biotech firms are partnering with technology companies to speed up the process.
为了降低成本,制药和生物技术公司正与科技公司合作,以加快这一进程。

US biotech Amgen is using artificial intelligence to improve trial planning, so it does not waste time and money setting them up in places where there will be few participants. Some 80 per cent of trials fail to meet enrolment timelines, and one-third of Phase III clinical study terminations are because of enrolment difficulties, according to a study by Cognizant, an IT company.
美国生物技术公司Amgen正在使用人工智能来改进试验计划,因此它不会浪费时间和金钱来设置参与者很少的地方。根据IT公司Cognizant的一项研究,大约80%的试验未达到入组时间表,三分之一的III期临床研究终止是因为入学困难。

Amgen has used off-the-shelf AI from large cloud providers such as Google and Amazon to analyse its previous trial data. Over the past five years, it has managed to shave three years off the time it takes to get a drug to market from the research stage, which averages 10 to 15 years.
Amgen使用来自Google和亚马逊等大型云提供商的现成AI来分析其先前的试用数据。在过去的五年中,它已经设法削减了从研究阶段(平均10到15年)将药物推向市场所需的时间三年。

A bigger prize than improving the efficiency of clinical trials is opening up new ways of diagnosis and testing treatments using wearable devices.
比提高临床试验效率更大的奖励是开辟了使用可穿戴设备诊断和测试治疗的新方法。

The Apple Heart Study, which announced its preliminary results last month, suggested wearables could be used to reach hundreds of thousands of participants. Lloyd Minor, dean of the Stanford School of Medicine, said the entirely virtual study was a "big leap forward in digital health . . . Technology has influenced and impacted every sector of the economy except for healthcare. Now we are positioned to be able to catch up."
苹果心脏研究上个月公布了其初步结果,该研究表明可穿戴设备可用于覆盖数十万参与者。斯坦福大学医学院院长Lloyd Minor表示,这项完全虚拟的研究是"数字健康领域的一次重大飞跃......技术已经影响并影响了除医疗保健之外的所有经济部门。现在我们的定位能够跟上来。"

However, it also highlighted potential pitfalls. The study, conducted by Stanford and funded by Apple, discovered the Apple Watch could be used to detect atrial fibrillation --- a leading cause of stroke --- that often remains hidden because people do not notice the symptoms. But just 34 per cent of people who received a notification of possible atrial fibrillation had it confirmed by an electrocardiogram patch. The researchers said this may have been because it is an intermittent condition. It could be a sign of false positives.
然而,它也突出了潜在的陷阱。这项由斯坦福大学和Apple资助的研究发现,Apple Watch可用于检测心房纤颤 - 这是中风的主要原因 - 由于人们没有注意到这些症状,因此常常会被隐藏起来。但接受心房纤颤可能通知的人中只有34%的人通过心电图贴片证实了这一点。研究人员说这可能是因为它是一种间歇性疾病。这可能是误报的表现。

Whether large tech or start-ups will win the battle to transform clinical trials depends on their reach, data, and ability to recruit employees with the expertise to separate the signals from the noise.
大型科技公司或初创公司是否会赢得改变临床试验的战斗取决于他们的范围,数据和招聘员工的能力,他们具备将信号与噪音分开的专业知识。

Neil Kurtz, an industry veteran on the board of Medidata, which makes software for clinical trials, said only a handful of people really understand how to use machine learning in healthcare. "Getting access to those people is going to be one of the key determinants of who wins and who loses," he said.
Neil Kurtz是Medidata董事会的行业资深人士,他为临床试验制作软件,他说只有少数人真正了解如何在医疗保健领域使用机器学习。他说:"获得这些人的机会将成为谁获胜和失败的关键决定因素之一。"

Alphabet's Verily is making the pitch that it can be a winner by designing its device specifically for trials, rather than as a consumer product with less oversight of who it is being worn by and when.
Alphabet的Verily正在通过专门为试验设计其设备而不是作为一种消费者产品,而不是作为一种消费者产品,而不会过多地监督它的佩戴方式。

As well as Project Baseline, the Study Watch is being used in a five-year study led by the University of North Carolina and Harvard of 5,000 people recovering from trauma, such as experiences in war zones or sexual assault.
除了项目基线之外,研究观察还在北卡罗来纳大学和哈佛大学领导的一项为期五年的研究中使用,该研究中有5000人从创伤中恢复过来,例如在战区或性侵犯方面的经历。

And in the Netherlands it is being used in the Personalised Parkinson's Project, a multiyear study to identify ways to track the disease's progression. Worn by newly diagnosed patients, the watch will collect vital signs, activity levels and information about the participant's environment. Its data will be compared with clinical and genetic information to try to find ways to predict differences in patients and develop new treatments.
在荷兰,它被用于个性化帕金森病项目,这是一项为期多年的研究,旨在确定跟踪疾病进展的方法。由新诊断的患者佩戴,手表将收集生命体征,活动水平和有关参与者环境的信息。将其数据与临床和遗传信息进行比较,以试图找到预测患者差异和开发新疗法的方法。

Verily's Dr Mega said she was a "big proponent" of consumer devices, but that if someone were using data from a wearable to make treatment decisions, there needed to be an extra level of rigour: "If you give someone a therapy based on that data, you want to be sure it was from you and not from your friend or your dog."
Verily的Mega博士表示,她是消费者设备的"大支持者",但如果有人使用可穿戴设备的数据做出治疗决定,那么需要更加严格的措施:"如果你给某人一个基于此的疗法数据,你要确定它是来自你而不是来自你的朋友或你的狗。"

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