Bold Blueprint for Precision Medicine Initiative’s Research Cohort
Posted on by Dr. Francis Collins
Readers of this blog know how excited I am about the potential of precision medicine for revolutionizing efforts to treat disease and improve human health. So, it stands to reason that I’m delighted by the positive reactions of researchers, health professionals, and the public to a much-anticipated report from the Precision Medicine Initiative (PMI) Working Group of the Advisory Committee to the NIH Director. Topping the report’s list of visionary recommendations? Build a national research cohort of 1 million or more Americans over the next three to four years to expand knowledge and practice of precision medicine.
When the President announced PMI during his 2015 State of the Union address, he envisioned a precise new era in medicine in which every patient receives the right treatment at the right time—an era in which health care professionals have the resources at hand to take into account individual differences in genes, environments, and lifestyles that contribute to disease. To achieve this, PMI’s national research cohort would tap into recent advances in science, technology, and research participation policies to build the knowledge base needed to develop individualized care for all diseases and conditions.
The Working Group’s report was accepted unanimously and enthusiastically by the Advisory Committee to the Director last Thursday. Based on that response, I formally accepted the recommendations and announced we would move into the implementation phase. To get a better feel for what Americans are thinking about PMI, I took part yesterday in a Twitter chat co-hosted by NIH and the White House Office of Science and Technology Policy. Also participating were Josephine Briggs, director of NIH’s National Center for Complementary and Integrative Health, who is serving as interim director of PMI Cohort Program while a search is underway for a permanent chief; and two of the Working Group’s three co-chairs, NIH Deputy Director for Science, Outreach and Policy Kathy Hudson and Bray Patrick-Lake, Director of Stakeholder Engagement for the Clinical Trials Transformation Initiative, Duke University, Durham, NC.
The Twitter chat proved to be quite popular, attaining a reach of more than 76 million potential impressions and attracting some 2,975 comments from 480 participants in 36 states. For a taste of the discussion, here’s a quick sample of what some of those folks were saying:
“Another remarkable aspect of #PMINetwork is appreciation of confluence of biology, environment, context, circumstances. The whole gemisch” @hmkyale
“Improved #communications, education can end #healthcare fragmentation so #PrecisionMedicine can fulfill its promise.” @Betsy_RSHC
“When can we start enrolling? I’m ready! #PMINetwork.” @trluperchio
In addition to the buzz on social media, the Working Group’s framework for the research cohort component of PMI attracted the attention of both mainstream and scientific media. While the news coverage was generally good, there remain a few misconceptions I’d like to clear up. At least one headline said that NIH planned to build a “genetic database.” While it’s true that genetic analysis will be a key part of PMI, the cohort will involve far more than simply studying DNA. In fact, the cohort will use a variety of innovative tools and technologies to gather information on participants’ behaviors, lifestyles, and environmental exposures as a means to better define how these factors influence health and disease. For example, it’s easy to envision using smart phone apps or other mobile health devices to monitor participants’ physical activity, track their sleep patterns, measure various aspects of cardiovascular function and metabolism, and even detect changes in the microorganisms living in or on their bodies. It’s also a good bet that a lot of data will be gathered to improve understanding of the aging process, as well as health differences between males and females.
Some have asked what will be done to safeguard the privacy of people who volunteer for the PMI research cohort, which is expected to start enrolling participants sometime next year. This responsibility is a high priority for the project. Last month, the White House completed its public comment period on PMI’s proposed privacy and trust principles, which are aimed at protecting participants’ personal data while, at the same time, making essential research data broadly available to qualified scientists.
Finally, I’d like to extend my sincere thanks to all 19 members of the PMI Working Group, especially its three hardworking co-chairs: Dr. Hudson, Ms. Patrick-Lake, and Dr. Rick Lifton of Yale University School of Medicine, New Haven, CT. It’s also been fantastic for NIH to partner on PMI planning with the White House’s Office of the National Coordinator for Health Information and the Food and Drug Administration (FDA). In fact, the recently named nominee for FDA Commissioner, Dr. Robert Califf, was an ex officio member of the PMI Working Group. With these and so many more great minds involved in drawing up this bold blueprint for PMI, I look forward to the day—hopefully, in the very near future—when NIH can set to work turning this exciting vision into extraordinary opportunities for moving precision medicine into all areas of health.
PMI Working Group Final Report
NIH framework points the way forward for building national, large-scale research cohort, a key component of the President’s Precision Medicine Initiative, NIH News Release, Sep. 17, 2015.
Precision Medicine Initiative: Proposed Privacy and Trust Principles (The White House)
As a former Biology, Genetics, and Molecular Biology teacher, and as a senior citizen, and as an admirer of Dr. Francis Collins about whom my students knew a lot because he is my hero, I would love to volunteer for the PMI study.
Thanks so much for your kind comments, Eleanor. I’m pleased to see that someone with your strong knowledge of biology wants to volunteer for the Precision Medicine Initiative. At the moment, we’re not quite ready to enroll volunteers. However, I can assure you that NIH will let you–and the rest of America–know when it’s time to sign up. So, stay tuned!
This is a fantastic opportunity for the poor to get personalized treatment by their physician. But will medicare and the regular health Insurance plans (of the poor and middle class) be forced to cover PMI? ie will all of us be able to get access to our DNA data and other tests which will help doctors to treat with preventitive, personalized medicine??
Hi Angela. NIH appreciates your feedback, but we want to provide you with a bit more information about the Precision Medicine Initiative. PMI is a research initiative that will generate the scientific knowledge needed to develop and test personalized treatments. It will not be involved in the routine delivery of health care covered by Medicare and regular health insurance plans. When NIH is ready to enroll participants in PMI’s national research cohort, it will be open to all Americans. Hope this helps!
Are there plans to do comparisons with other countries which have government funded national health plans?
Louise, thanks for your question. PMI is still in its planning phase, with many details of this research resource remaining to be worked out. But it’s certainly possible that, along with many other types of research, scientists may use the information gathered by PMI to make international comparisons. We hope you keep following PMI’s progress, and thanks again!
How will we KNOW when you are enlisting volunteers? Do you have an estimated timeframe?
Thanks so much for your comments, Jane. One way that NIH will let Americans know when PMI is ready to sign up volunteers is through the PMI web site, http://www.nih.gov/precisionmedicine. NIH will also spread the word through social media, including the NIH Director’s Blog, Twitter (@NIH and @NIHDirector) and Facebook (National Institutes of Health). While we don’t yet have an exact start date, our goal is to begin enrollment in the PMI national research cohort sometime next year.
There seems to be so much lost information from one speciality to another. I’ve felt that physicians sometimes have seemed threatened when a patient tries to connect the dots or ask if information could be shared to try to help. I’m an RN. My own experiences as a mom of a child who suffered brain damage during labor and delivery, as well as a medical person, kept me trying to suggest that doctors hear the histories & chance comparing notes. The research will help everyone. Hope I can be of an age to sign up.