2015年3月11日讯 /生物谷BIOON/--每一年，苹果公司的新品发布会都吸引了全世界的焦点。而几天前刚刚结束的春季发布会也不例外。然而，与往年不同的是，此次苹果发布会的一大亮点就是将iPhone从一部提升"逼格"利器转变为了临床研究辅助用品。
此次，苹果公司发布了新的软件架构ResearchKit，有望帮助700多万部iPhone手机的用户，让他们手中的电话变成医疗诊断工具。ResearchKit是一个开源框架，可以让医学研究人员创建诊断应用程序，点击iPhone的屏幕就可以使用它，以及来自HealthKit应用程序的数据。
截止到目前，苹果已经联合包括首都医科大学宣武医院在内的全球多家著名医疗机构用此框架开发了首批app ，现已上线的有5 款，分别是针对帕金森的 mPower、针对糖尿病的 GlucoSuccess、针对心血管的 MyHeart Counts、针对哮喘的 Asthma Health、针对乳腺癌的 Share the Journey。这不得不说是苹果公司投下的一个重磅炸弹。
然而，在果粉的阵阵惊呼中，生物医药产业分析人士却是态度各异。一些分析人士担心苹果公司开放的这一软件框架最终可能沦为鸡肋。
首先，使用iPhone提供的自检数据有效性值得怀疑。患者在没有专业人士指导下测定的相关数据是否可靠？研究人员如何筛选这一庞大数据库中的可靠数据？要知道，在FDA对临床数据审核标准已经达到近乎"苛刻"的今天，任何一点数据瑕疵都会成为整个临床研究失败的导火索。
此外，对于发展中国家（如中国）来说，一部iPhone的价格不菲，因而使用iPhone的患者都具有一定的经济实力，这无形中就为苹果雄心勃勃构建的这一数据库加上了一个门槛。分析人士担心这一筛选条件会影响最终临床研究的客观性。
第三，也有分析人士指出这一框架对患病人群的吸引力要大于健康人群。这一问题反映到慢性疾病上尤为突出。试想一下，作为一个健康用户，我为什么要参与与我相距甚远的糖尿病临床研究？
不过，也有许多观点认为苹果的ResearchKit对生物医药研发具有极大的推动作用。首先，无论是否具有选择偏好，苹果推出的ResearchKit都有望将患者的数据库扩大，而这也是目前生物医药企业进行临床试验最为头痛的症结之一。同时，这一架构也使科学家们看到这一应用未来在生物信息学方面的广泛应用。这一功能无疑与美国总统奥巴马最近提出的"精密医学计划"不谋而合。
因此，在小编看来，尽管苹果此次推出的ResearchKit框架或许存在一定的缺陷，但仍不失为一个突破性的发明。我们期待着未来ResearchKit能给生物医药产业带来更多的惊喜。
详细英文报道：
Amid all the pomp, circumstance and sans serif fonts in Apple's ($AAPL) latest product launch, the company took a break from pumping expensive new gadgetry to unveil a piece of software with the potential to change the medical research landscape. Dubbed ResearchKit, Apple's new platform promises to transform the world's hundreds of millions of iPhones into handheld gatherers of clinical data, which some say will usher in a new era of biomedical science but could well amount to more questions than answers.
The idea is fairly simple: Using the open-source ResearchKit as a framework, medical institutions running clinical trials can design apps that keep tabs on patient-reported outcomes, measure vital signs or otherwise use the iPhone's many sensors to harvest information. By downloading them, patients can enroll in such trials from anywhere in the world, consenting to share their data over what Apple says is a secure network. The full service goes live next month with the release of Apple's latest iPhone operating system, but the company debuted 5 ResearchKit apps during Monday's pep rally, software designed to measure symptoms ofasthma, Parkinson's disease, diabetes, breast cancer and cardiovascular disease.
The goal, according to Apple, is "taking research out of the lab and into the real world," breaking down the barriers to clinical trial participation and providing researchers with an ocean of actionable data they can use to better understand disease, develop new drugs and hone existing treatments.
But despite some soaring cosigns from high-profile institutions, ResearchKit is unlikely to be a panacea for the problems that currently plague clinical trials. For one, it will be quite difficult for investigators to ensure the quality of the data they get from self-selected app volunteers. There's no way to guarantee that users of, say, the breast cancer-tracking Share the Journey app actually have the disease, opening up the possibility that its resulting data will be murky and unreliable. And such concerns will be particularly acute for forthcoming apps that hope to gather data that will stand up to peer review or FDA prodding.
Furthermore, ResearchKit has an in-born selection bias: Each one of world's millions of iPhone owners necessarily has the financial wherewithal to buy an iPhone, something that may deter investigators hoping to cast a wide socioeconomic net. And while the format may be ideal for people who either have or believe themselves to be at risk for a particular disease, it might be difficult to convince healthy volunteers to willfully and consistently take part in data-mining activities, thereby constraining the types of information ResearchKit can generate.
That said, for researchers hoping to make headway in chronic, widespread disease, a huge dump of patient data, however noisy, is a net gain, the American Heart Association's Eduardo Sanchez said in a statement from Apple.
"The more people who contribute their data, the bigger the numbers, the truer the representation of a population, and the more powerful the results," Sanchez said. "A research platform that allows large amounts of data to be collected and shared--that can only be a positive thing for medical research."
Others see the potential of ResearchKit as a complementary tool to genomic profiling. Widespread genome sequencing, like what's promised in President Barack Obama's Precision Medicine Initiative, is great for identifying genotypic trends in healthy and diseased patients, but it's not so helpful in matching those traits to real-world, phenotypic outcomes. A tool like ResearchKit could help complete the picture for investigators taking a holistic approach.