White House Enabling Research Data Sharing, NIH Official Says

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May 10 — The White House's decision to back data-sharing policies is already removing barriers to collection of research data, an NIH precision medicine aide said May 10.

Bray Patrick-Lake, who is part of the precision medicine initiative leadership at the National Institutes of Health, said because that policy shift is happening at the top level, changes won't require waiting another five years.

“The earth is crumbling in a very positive way,” she said at a session on speeding up the pace of medical research using patient-provided data during the Health Datapalooza conference.

She recalled how during a White House summit on precision medicine in February, President Barack Obama said he believes patients should own any data generated from a medical or genetic test (10 LSLR 05, 3/4/16).

“He actually went on to say that universities are known for data hoarding,” Patrick-Lake said, drawing audible murmurs of agreement. “That is very threatening to people who have created these business models around taking data and not sharing it. So I do think we’ve already seen the shift in certainly direction from leadership, but we have to continue breaking these business models down.”

Patrick-Lake is at the NIH on a yearlong detail from Duke University, where she is the director of patient engagement for research programs. She identified change management as the barrier to easing patient-contributed data into medical research. This involves integrating policies developed by thought leaders and early adopters into every-day clinical practice by health-care practitioners who aren't necessarily following every detailed policy that comes out of Washington.

Realign Incentives

Amy P. Abernethy, chief medical officer of Flatiron Health, a New York company focused on organizing the world's cancer data, said there's also a need to realign incentives so that the “data points that matter to us in our daily lives are actually part of how we understand moving medicine forward.”

She discussed her experience with the Oncology Care Model, a program under development at the Centers for Medicare & Medicaid Services in which participating chemotherapy providers would receive a monthly care management payment of $160 for each Medicare fee-for-service beneficiary and also would receive a performance-based payment for providing oncology services.

As the program developed, Abernethy said, technology companies were preparing to develop the tools, solutions and work flow to incorporate patient-reported outcomes on a wide scale. But when the CMS didn't include patient-reported outcomes in the program's rules, Abernethy said, the efforts stopped immediately.

“When it looked like the incentive was going to turn up the heat,” Abernethy said, “all sides of a story were trying to figure out how to make it happen. When the incentives stopped, the story shifted to something else.”

No Simple Mechanism

Jennifer C. King, co-founder of Share For Cures Inc., a nonprofit that seeks to help people use their health data to advance medical research, said there's no simple mechanism for patients to donate their data for research. Most people don't participate because they either didn't know about a study, the study isn't being offered or a patient isn't eligible for a specific clinical trial. “It’s much, much rarer to find patients who say, ‘I didn’t want to participate in this research.' There’s a lot of motivated people who would do it. They just don’t have the mechanisms right now,” King said.

Vanessa Rangel Miller, vice president of genetics services for PatientCrossroads.com, said there’s a gap in how researchers develop valid metrics for measuring a patient's progress in treatment compared to what patients want to know.

For example, a researcher might measure outcomes for a disease by mobility, such as being able to walk a certain distance. “But when you ask patients, they say ‘I want to be able to text my friend. I want to be able to feed myself.' It wasn't so much that ‘I want to be able to walk six meters,'” she said. “We need to put this information back into the health-care system in a way that’s meaningful. But in order to get there, we need to engage” the patients.

PatientCrossroads.com is a company that connects patient registry programs with researchers, advocates and industry organizations working to understand or treat specific diseases and conditions.

To contact the reporter on this story: Jeannie Baumann in Washington jbaumann@bna.com

To contact the editor responsible for this story: Randy Kubetin rkubetin@bna.com

For More Information

More information on the Health Datapalooza conference is available athttp://healthdatapalooza.org/2016-agenda-day-2-protected/.