Apple's new ResearchKit: Disruptive force in R&D or flashy red herring?

Apple's iPhone with ResearchKit app--Courtesy of Apple

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 of asthma, 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.

- here's Apple's announcement

Read more on