Columbia's David Goldstein: Precision medicine will change disease treatment paradigm


Editor's Note: This article is Part 1 of a two-part series.

David Goldstein
David Goldstein

Precision medicine is about changing the paradigm of how the industry targets treatments of disease--but to see that realized, the generation of large medical data sets is essential, says David Goldstein, director of the Institute of Genomic Medicine at Columbia University Medical Center.

Goldstein’s organization is one of many looking to do just that as part of President Barack Obama’s Precision Medicine Initiative. The medical center in July received a grant from the National Institutes of Health to participate in the initiative’s Cohort Program.

In a group alongside Weill Cornell Medicine, NewYork-Presbyterian and NYC Health + Hospitals, CUMC will use $4 million in funding to enroll 150,000 patients in the cohort. The NIH wants more than 1 million patients participating in the program overall.

Goldstein tells FierceHealthIT that in addition to getting those patients enrolled, the organizations also will help ensure that participants stay through the life of the program, as well as ensure as many of them as possible “engage substantively with the research being done.”

“Fundamentally, precision medicine is about improving the understanding of the causes of disease and using that understanding to target our treatments as much as possible to the underlying cause of disease,” says Goldstein, who is the contact principal investigator for the Cohort grant. “It doesn’t take long to realize that we largely target treatments in a way that is independent of any knowledge of the underlying cause of disease.”

This program, he says, will change that paradigm.

The NIH, according to Goldstein, will give organizations involved a framework for a standard experience for patients participating to ensure everyone involved is on the same page.

While the exact recruitment start date has not been agreed upon, Goldstein says it will begin within the next several months.

Still, he says there already is “some ideas about what’s likely to happen,” such as collection of blood samples for eventual DNA extraction, and down the road use of wearables devices and monitors to collect myriad types of data.

Also at some point there will be collection and standardization of health records, Goldstein says.

This is a new totally new way to do this kind of work, he adds, emphasizing the importance of not only having basic biological samples from which to generate genomic and other omic data, but having access to swaths of underlying clinical information, as well.

That allows for “a much broader exploration of the relationship between the data generated,” he says.

As for how to get patients excited about joining the program, Goldstein says participants will be made aware that they will be given an “unprecedented” degree of access to their data.

“We don’t want to start making promises about how participation will change or transform anybody’s medical care, but I think it is fair to say that there will be cases where data that are generated will be useful in that way, and the program is committed to ensuring that participants benefit from anything that emerges from this program,” he says.

Of course, there are concerns when it comes to privacy and security, an issue with which the industry is all too familiar.

Goldstein notes that is a “very, very real concern.” He hopes participants going in understand the focus being put on keeping their data secure, and that “the people involved in the study understand that we simply must do everything we possibly can to maintain the trust of the participants, and to protect the data that are generated about them.”