When Apple first announced ResearchKit, it was met with a fair amount of skepticism about whether the data collected via smartphones would be robust enough to be useful. But just a few scant months after that announcement, it seems many in healthcare are at least paying attention to the possibilities of smartphone-based data collection in general and ResearchKit in particular.
Last week the National Institutes of Health made it clear they were looking into something along those lines for the White House's Precision Medicine Initiative. Now Buzzfeed is reporting that at least two pharma companies -- GlaxoSmithKline and Purdue Pharmaceuticals -- are looking into ResearchKit projects of their own.
GlaxoSmithKline confirmed it was "currently working on integrating (ResearchKit) into clinical trials and planning to start in coming months." Purdue said that they're still in the early stages of developing something for the platform.
"We know that all these changes in tech are going to impact health care, but we don’t know exactly how,” Larry Pickett Jr., Purdue’s vice president and chief information officer, told BuzzFeed News. “People have been talking about it for a long time, but haven’t been able to figure out how to leverage that data and take advantage of it. My team views ResearchKit as a very significant milestone in being able to move that capability ahead.”
But a few other pharma companies told Buzzfeed they're expressly not working with ResearchKit -- Gilead Sciences and Pfizer. The latter is particularly interesting, because Pfizer has been one of the leaders in the idea of remote clinical trials. Pfizer's Head of Clinical Innovation Craig Lipset was on a panel at life sciences conference BIO this year where panelists discussed the importance of novel methods of data collection.
"We have models of clinical development that were built for a blockbuster era,” Lipset said at the time. “…We need new approaches that are able to help us identify patients more appropriately, and other ways of capturing data, whether it’s partnering with health systems or partnering with patients to aggregate and share data on their own. Because in today’s state in healthcare, we as patients have unprecedented access to our own data, and our own ability to serve as data hubs and aggregators of our own data. And patients have that willingness to share their data to support research. When you couple that with different molecular approaches, that creates tremendous opportunities for us to actually scale clinical trials.”
The context of that discussion was around precision medicine -- the idea that some conditions are going to require highly specialized therapeutics, based on the patients' individual genetics. It won't be efficient to develop these drugs the way pharma companies have always developed blockbuster drugs, but it could be done with a platform that enabled pharma companies to do decentralized remote trials on large groups of patients fitting a highly specific profile -- something like ResearchKit.
I'd be surprised if the pharma companies that are investigating ResearchKit now aren't thinking about this forthcoming sea-change in drug development. If ResearchKit or something like it can overcome certain regulatory and logistical barriers, it could become the research platform that pharma needs to develop the drugs that make sense for the 21st Century.
Clinical trials are just one use case pharma companies might find for mobile data collection to address the changing face of pharma. Novartis told the Wall Street Journal this weekend that its new heart failure drug, Entresto, might be among the first to be sold with remote monitoring tools as an add-on service, to help convince insurers to spring for the more costly drug. The monitoring tools could even allow insurers to get a partial refund if the drug doesn't effect outcomes, essentially setting up a pay-for-performance arrangement for Novartis.