SAN FRANCISCO — Health systems and hospitals that are taking financial risk for keeping people healthy aren't the only ones that want access to patient-generated data.
Pharmaceutical and biotechnology companies are increasingly interested in how patient-reported information can be used to get their products to market faster and assess how they perform in the real world.
At the Biotechnology Industry Organization's annual conference, familiar names in digital health were front and center in the program and exhibit hall. And for the first time, the Digital Health Summit held its annual summer meeting alongside the larger BIO conference.
On the other side of San Francisco, one of the better-known wearable companies, Fitbit, was holding its annual Captivate Summit, where the employer-focused agenda included panels on how wearables are changing health research.
Patient-generated data from technologies like wearable devices have the potential to increase clinical trial recruitment by reducing the burden on patients and allowing them to make fewer visits to the clinical trial site, said Ferry Tamtoro, director of digital accelerator labs at Amgen, during a panel at the Digital Health Summit.
Wearables also have the potential to generate objective data on a faster timeline than the current way of assessing patient outcomes, which are largely still patient-reported.
“If you think about outcomes research, you really want to measure what's most relevant to patients,” said Alicyn Campbell, global head for patient-centered outcomes research at Genentech. “There are a lot of concepts that are relevant to patients that are difficult to measure right now. We can't ignore what's available right now in consumer wearables.”
Drugmakers are hoping to use that information for post-marketing and comparative-effectiveness studies—a key part of what they'll need to justify reimbursement from insurers.
Quintiles, a clinical research organization, has seen an increasing number of requests from drugmakers to look at how and when to use patient-generated data, said Jennifer Christian, vice president of clinical evidence in Quintiles' real-world and late phase research group.
“It's so important particularly where there's heterogeneity in the disease and in the patient experience,” she said, pointing to conditions like lupus and multiple sclerosis that can manifest very differently across patient groups.
It's not just wearables that are getting attention, but also unstructured data in an electronic health record that can reveal important information about how a drug is performing, Christian said. For instance, a physician's notation can indicate whether a patient has been able to return to work or how a drug is affecting his or her mood.
A number of technology firms like IBM Watson and Ayasdi have focused on how to capture that data and make it useful for drug developers.
Another application of machine learning tools is social listening, Christian said, or aggregating data from social media sites like Facebook and Twitter and using it to track early indicators of safety issues for a product. In 2013, GlaxoSmithKline issued a recall of a children's pain reliever marketed in Australia after a Twitter user noticed that the label on the dosing syringe was printed incorrectly.
However, biopharma companies need to be cautious that they're measuring relevant endpoints and not just creating more noise in the data, Genentech's Campbell said.
Providers who are being asked to incorporate wearables into caring for patients also are concerned about the potential for added work and information overload, said Dr. Albert Chan, vice president and chief of patient digital experience at Sacramento, Calif.-based Sutter Health and another panelist at the Digital Health Summit.
The Food and Drug Administration last year began seeking input from stakeholders on how to incorporate information from wearables, remote monitors and other sensors into clinical trials.
To that end, Flatiron Health, a New York-based analytics company focused on oncology, last month began participating in a research collaboration with the FDA that will assess how patient data from outside clinical trials can play a role in evaluating new immunotherapy treatments.
Flatiron's technology can pull structured and unstructured data from electronic health records and other sources that can then be analyzed and used to find patterns. The FDA collaboration will focus on how to evaluate data quality and how the data can be applied to answer clinical questions.
“We need to do this in a really thoughtful and safe way,” said Dr. Amy Abernathy, Flatiron's chief medical officer, “rather than just push a button and the computer spits out an answer.”
