|NCI acting director Dr. Douglas Lowy explains his institute’s component of PMI at a stakeholders’ briefing in Wilson Hall.
Collins announced that while a nationwide search for a PMI director will begin soon, the effort will be led in the interim by Dr. Josephine Briggs, director of the National Center for Complementary and Integrative Health. The first task is to prepare a research infrastructure and to begin enrolling, in January 2016, a cohort that reflects the diversity of the U.S. population with respect to age, gender, race and ethnicity.
“But this is all contingent upon congressional appropriations,” noted Collins, just days before the end of fiscal year 2015; PMI is budgeted at $215 million in FY 2016—$130 million for the large-scale cohort and the balance for an NCI component.
Collins said PMI is “a long-term endeavor,” scheduled to last at least 10 years. “I hope to see it go much longer,” he said, calling it a complex and ambitious initiative that could rival the Framingham Heart Study, ongoing since 1948, as a producer of useful medical knowledge.
In response to questions from reporters, Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, said there are “two doorways to enter the study”—via health care provider organizations such as Kaiser Permanente, which have already established electronic health records (EHRs), or by “anyone, anywhere, simply signing up as a direct volunteer.”
Hudson said, “Motivations to participate are multiple…there is a strong thread of altruism that we hope to tap into…People are interested in getting [medical] information back about themselves. Our surveys have shown that people find it attractive.”
Collins said NIH is “very much aware of opportunities” offered by already-existing cohorts, which, in addition to KP, include Geisinger Health System, Intermountain Healthcare, Mayo Clinic, Marshfield Clinic and others.
“It will be very valuable to build upon [these cohorts],” he said. “We very much want to engage with them.” Collins said both arms of enrollment—volunteer and legacy cohorts—“are going to be pursued avidly…The value of a cohort gains over time.”
PMI workgroup cochair Dr. Richard Lifton of Yale University, who also participated in the telebriefing, predicts that some cohort enrollees might find themselves invited to participate in future clinical trials, based on a spectrum of personal characteristics.
Participating in a PMI briefing for stakeholders on Sept. 25 at NIH are (from l) Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, NIH director Dr. Francis Collins, and Lowy.
Photos: Bill Branson
Collins added that EHR technology itself will likely be revamped and upgraded as PMI progresses. “Perhaps we can move the needle in improving the way EHRs function overall,” he said.
One reporter wondered what NIH would do if 3 million people wanted in on the study. “That’s a potentially serious possibility,” said Collins. “There’s been a lot of increase in the public’s interest in participating in research. When you open the door to the nation, you don’t know how many will respond. But it’s a great problem to have. Maybe we’ll have to say, ‘Going fast! Only a few tickets left!’”
PMI will rely heavily on mHealth, or mobile health, with enrollees using smartphones and personal devices such as Fitbits and Jawbones to collect and monitor health data, said Dr. Josh Denny, associate professor of biomedical informatics and medicine at Vanderbilt University, another PMI advisor.
Collins imagines that some cohort enrollees could be fitted with wearable on how where we live contributes to health or
Asked to sum up PMI’s value, Lifton concluded,
“This is a meritorious thing to do,
a really extraordinary and unprecedented
opportunity to determine personal disease
cause and risk…It also offers open access
to all investigators, offering novel analytic
Collins emphasized that cohort participants
“are partners in all we do.”
“We’ve been welcomed to the table,” said
PMI cochair Bray Patrick-Lake of Duke
University, a disease advocacy activist who
admitted to having been skeptical about PMI
at the outset. “PMI is committed to doing
what’s right, not what’s easy.”
“I think we’re on a pathway that can be
quite transformative,” said Collins. “It’s going
to teach us a lot about health…We are thrilled
to be given this charge by the President.”