The promise for big data looms large – so large, in fact, that it’s become difficult to separate the facts from the hype.

That’s part of the reason for Big Data For Patients (BD4P), a training program intended to give patient advocates and others who assist patients a working understanding of what big data is – and just as importantly, what it isn't.

Also See: What is Big Data?

The Reagan-Udall Foundation for the Food and Drug Administration (FDA) recently announced the program, with the goal of having it help more patients understand the potential benefits and important cautions associated with big data.

Confusion over big data in healthcare is significant, says Jane Reese-Coulbourne, executive director of the Reagan-Udall Foundation.

"The advocates are saying, 'I don’t know what this is,' and I keep saying, 'That's because it's not really anything,' Reese-Coulbourne said.  "It's everything and nothing. I want to say when we get done, 'See how big data is being misused and how it's a catch phrase?' "

Reese-Coulbourne said the training program is designed to give patient groups a working knowledge of the nuts and bolts of the datasets that the industry uses, and to be able to assess its true capabilities.

The RUF would appear to be the ideal venue for such a program. Established by Congress in 2007, the foundation supports regulatory science research by fostering public-private partnerships and supporting ongoing training and scientific fellowships. It operates independently of the FDA, with its own staff, research agenda, board of directors and funding. It does not offer advice to the FDA on regulatory matters or policy issues.

Patient advocates who complete the training will be ready to share meaningful input on large-scale big data initiatives, such as the National Institutes of Health’s Big Data to Knowledge program, FDA’s Sentinel initiative and PCORnet, the National Patient-Centered Clinical Research Network, which is funded by the Patient-Centered Outcomes Research Institute (PCORI).

PCORI is also funding the BD4P program's initial activities with a $250,000 grant. Reese-Coulbourne said other funding organizations, are offering RUF financial support to get it rolling. "I don't think we'll have a problem with resources," she added.

Reese-Coulbourne said BD4P will be patterned after the National Breast Cancer Coalition's Project LEAD, which was established in the mid-1990s to provide functional scientific knowledge of the disease to patient advocates. She said such training is vital for the foundation of 21st century healthcare research and delivery.

"We already went through it once, a small group of us, and were able to make it work for the science of cancer. Granted, it's a different science, but there's some overlap."

Initial steps will include conducting a needs analysis for the program, she said, adding that she hopes to have the tool for that assessment launched by this fall. A pilot program is tentatively scheduled to begin in mid-summer 2016.

That pilot program, and perhaps others will refine educational approaches, she said. "We'll be incorporating input from not only scientists but also teachers who are skilled in adult learning – so many of the patients who participate in these programs pick up a passion for scientific learning they never had as children. They are very dedicated."

Based on what she's heard from those familiar with the project, there should be no shortage of volunteers to participate in it. Expansion opportunities also are developing, she adds. “Since we announced the program publicly, I got a call asking if we can do this course for clinicians – which, trust me, they desperately need. I also did an interview with someone who asked if there might be a course like this offered for the press."

In fact, she said, she can envision a series of BD4P classes, from the "Big Data 101"-style introductory class to more advanced sessions that emphasize critical evaluation of scientific method.

"We're in the discussion phase right now, but as patients start to have real input into things and know how to do it better – and we know how to capture it better – I think it's really going to make an impact on how drugs are developed and how things are done."

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