麻豆传媒

ANAHEIM -- Separating medical practice from research no longer makes sense, said Robert Califf, MD, calling on every clinician to become a clinical investigator.

"This is the most prestigious job," said Califf, ex-FDA Commissioner and practicing cardiologist now working with Google's biomedical research arm Verily, during his Laennec Clinician/Educator Lecture here at the American Heart Association's annual meeting. "It's incumbent on every practitioner to participate in the system and make it better."

In fact, he said, "it may be good to change the word from 'research' to 'learning,' which is what it really is."

Califf suggested that providers can put the constant generation of data from wearables and electronic devices to use. "We need to work together to create a situation where we enjoy the fluidity of information outside of the healthcare sphere when we operate inside the healthcare sphere. We have to organize and store the information in the right way, and then draw inferences about what should be done."

This is important because the medical community needs to understand that behavior and social factors affect 99% of most people's health, in contrast to the remaining 1% spent in hospitals and clinics.

"If we're going to make a difference, we have to integrate the 99% with the 1%."

"Where things are headed, information systems or operating systems are capable of analyzing and storing this information at a fraction of the cost from 2-3 years ago, partly due to cloud computing," he said.

Verily, Duke, and Stanford are taking advantage of this with , an initiative seeking to "map human health." The health tracker used in the study measures 17 parameters, Califf noted.

"The other tremendous source of information that's happening on the Internet are the 3 billion searches done every day on Google. One in 20 are health-related searches. There is an increasing effort to curate the information so you're not bamboozled by patients who come in with their printouts of pages with unreliable information. If we don't fill in the gaps in unreliable information, someone else will. It's easier to make up a fake story about vaccination than to do research and to tell the truth."

He suggested that the stakes couldn't be any higher. "We need to share and integrate this information. If we don't, we will fall prey to people who will integrate information and use it in ways we don't like."

Yet the biggest challenge is how to incentivize practitioners to take part in research: "All the other things to do are moving along. The data are getting better. But we have a system that has a billing approach to it, so clinicians are diverted to pursuits that are not beneficial to patients," Califf said.

The feasibility of getting every practitioner on board is the issue, agreed Jil Tardiff, MD, PhD, of The University of Arizona Sarver Heart Center in Tucson, who conducts basic research science. Her problem with traditional trials is that their results are not always applicable to many patients. "I think that all clinicians potentially have unique practices that encompass patients that are not often included in the trials conducted by big academic centers and these demographics end up being excluded," she told 麻豆传媒.

But to fix this alone would require a total overhaul of every other piece of the research puzzle. Upfront institutional costs to centralize data-gathering and to provide training to practitioners (most of whom have no trial experience) are a major unknown. Costs aside, there is also the hurdle of the enormous and necessary regulatory structure currently involved in clinical studies, according to Tardiff.

For clinical researcher Daphne Hsu, MD, of Children's Hospital at Montefiore in New York City, the age of ubiquitous data via wearables and other devices may be a double-edged sword.

"Medical data is personal and it is very important to respect the need to ensure that data is not inadvertently shared. These days it seems harder to guarantee this privacy," she said, commenting that one barrier standing in the way of Califf's proposals is "making sure that patient data that is collected is kept in a de-identified and secure manner and patient privacy is protected."

Nonetheless, she agreed that research and information gathering should be performed in all patients and all settings where patients get their care. "This will give us a much better sense of how a disease affects all patients and allow us to understand who a particular treatment would help."

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