San Francisco, CA — The revolutionary look and feel of many modern clinical trials are exemplified by three new studies from a very powerful sponsor: Apple. The sleek-tech giant is leveraging the same data that you, possible iPhone user, might examine in your Apple Health app. But Apple will examine more than a million such datasets, as it scrutinizes people’s activity in three critical realms—menstruation, mobility and hearing.
For the menstruation study, Apple is aiming to learn more about how women’s bodies and reproductive health change over the course of their lives, and they’re partnering with the Harvard School of Public Health. “I’m most excited about the fact that we’ll be able to collect women’s menstrual cycle information in ways that we’ve not really done before,” said the school’s dean, Michelle Williams. “Having this data on a large modern cohort is so relevant to clinical women’s health today because a lot of the decision making and diagnostic protocols that we’re currently using are from data from 50 years ago, when the social environment was different.”
Modern smartphones and wearables often have astounding detection capabilities. Apple Watches, for example, will be used in the hearing study, for the noise meters they’ve got inside. Leveraging those, Apple is aiming to help make study participants aware of the sound exposure in their personal environments and thereby help reduce the risk of hearing loss.
Study volunteers get to choose exactly which data they share with Apple’s researchers, and they can also elect to stop sharing data at any time. iPhone users who are not part of the study need not worry about their health data being used by anyone else; it’s stored locally on their devices, and Apple has no line of sight into it.
Given the data-capture capabilities of many personal devices, the opportunities for virtual trials like these are critically important. They save time and money and open studies up to whole geographies’ worth of people typically unable to access clinical research. That said, brick-and-mortar trial sites and in-person data collection are still important in many therapeutic areas. So, while we should expect more completely-virtual trials like Apple’s, the coming years may show us more hybrid approaches: studies in which some data is collected at trial sites, with many other check-ins taking place virtually or remotely. This eases the burden on patients and sites alike, while ensuring rigorous and appropriate monitoring.
One way Apple is maximizing its move into clinical research is by taking advantage of opportunities for branding. The studies are called the Apple Women’s Study, the Apple Hearing Study, and the Apple Heart and Movement Study. We expect to see many more such branded trials, some with catchy names, engaging recruitment techniques, and colorful data-shareback, as life sciences companies borrow plays from the bigger commercial world in order to differentiate their products from the start.