Jun 07, 2016
The first major contract in the President's Precision Medicine Initiative, for $142 million over 5 years, will go to the Mayo Clinic in Rochester, Minnesota, announced Kathy Hudson, PhD, deputy director for science, outreach, and policy at the National Institutes of Health.
The Mayo Clinic will use the award to build what Dr Hudson described as the world's largest research biobank, with a capacity for 33 million specimens, and make data and samples available for widely shared science.
"What we're trying to do is build a cohort of a million or more volunteers," she told attendees at the Big Data in Biomedicine 2016 Conference in Stanford, California.
Although it won't be statistically representative, "we hope it will reflect the diversity and richness of our population," she noted.
Participants will be recruited through healthcare provider organizations, but anyone anywhere will be able to raise their hand and say they want to participate. The cohort will be longitudinal, and researchers will have the ongoing ability to interact with participants.
Open enrollment will likely begin this fall, Dr Hudson reported. However, it will take several years to get to a million, she cautioned. The goal is to have the infrastructure in place, 79,000 people signed up, and a handful of research projects under way by December, she explained.
Participants Will Be Partners
Participation in the Precision Medicine Initiative cohort will be open to everyone, and participants will be partners at every step, from the planning groups to the Institutional Review Board, said Nancy Kass, ScD, a bioethicist at Johns Hopkins University in Baltimore, Maryland, who will chair the board for the cohort.
The planned research has to do two things: "It has to be kick-ass science, and it has to build the relationship that we have with participants," Dr Hudson said. "It has to be stuff the participants will view as beneficial, that will build and not erode their trust in this program," she added.
The biobank will provide access to information not just for the research community, but for the partners and participants, who will also have access to their own information.
Protecting privacy and securing data come with many challenges. When inviting people to enroll, "we're going to have to be clear with them that there's no 100% guarantee of privacy and safety," said Dr Hudson.
One extra layer of protection for people donating their data will be the use of certificates of confidentiality, already recognized by federal law. The certificates have been issued in the past to empower researchers to resist subpoenas for information on mental illness and criminal behavior that has been used in research. They are also standard for genetic research.
"There are moves to strengthen certificates of confidentiality so that if you're doing research that's funded by us, you will automatically get a certificate of confidentiality and that allows you to say, 'no, I will not disclose,' even if somebody tries to compel disclosure," Dr Hudson explained.
The Precision Medicine Initiative is also working on a pilot project with Federally Qualified Health Centers to make sure that people who have been traditionally under-represented in biomedical research will be represented in the cohort. This will help to further understanding of healthcare disparities.
Cohort Will Include Children
The biobank will also enable researchers to recruit people, including children, through the cohort for substudies on specific diseases.
Being able to study children and track information over decades is particularly exciting, said Yvonne Maldonado, MD, from the division of pediatric infectious diseases at the Stanford University School of Medicine.
"What you want to be able to understand from the very earliest time of a person's being is how your genetic and epigenetic information predicts what your health outcomes are going to be later in life," she told Medscape Medical News.
Such information will allow researchers and healthcare providers to tell patients what could happen to them and how to prevent problems, she explained.
Among the biggest challenges for the initiative will be securing the data and specimens and systematically coordinating information from a wide array of electronic health record systems.
"Google and Yahoo and other tech giants manipulate data on a daily basis, but we need to see if we can do that outside these highly skilled private groups," said Dr Maldonado. "We have to move to this step to move human health to the next level."
Source: Medscape