Precision Medicine Initiative announces cohort pilot, partnerships, pledges, principles

During the White House Precision Medicine Initiative Summit on Feb. 25, National Institutes of Health director Francis S. Collins, MD, PhD, announced several new actions to accelerate the initiative.

The NIH will give an award to Vanderbilt University Medical Center, which will lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the cohort program. The objective is to build a broad and diverse national research cohort of 1 million or more U.S. volunteers whose participation will provide the platform for expanding approaches to precision medicine. The team will explore optimal approaches and systems for engaging and enrolling participants, said Collins. The initial volunteers will help establish and test innovative technologies for enabling user-friendly data collection. The team will “help us learn how to create durable relationships with volunteers who will be true partners.”

The NIH and the Health Resources and Services Administration will begin partnerships with federally qualified health centers around the country to engage underserved and underrepresented groups in the study cohort.

Thirty organizations have pledged their commitment to “Sync for Science,” which gives patients the tools to donate their own health data to improve health outcomes and treat disease.

The White House also will release a draft of data security policy principles related to precision medicine. The Office of the National Coordinator for Health IT and the National Institute of Standards and Technology will develop a precision medicine-specific guide to cybersecurity by the end of the year.

HHS’s Office for Civil Rights will issue additional guidance on people’s rights to access their health information under privacy laws. This will aid in the effort to enable individuals to send copies of their health information to anyone they want, including researchers.

President Obama, who also spoke during the summit, expressed his hope that this becomes “the foundational platform to revolutionize the care of diseases that have caused so much pain and suffering.”

One promise of precision medicine, Obama said, is that rather than our current system that waits until someone is sick, the initiative will empower individuals to monitor and take a more active role in their own health.

While “we’re in the infancy of this,” Obama also noted the need to “break down some of the structural or institutional barriers that prevent us from making big leaps over the next several years.” More samples means more data, which means more to learn.  

The Precision Medicine initiative is a “bold initiative unlike any other this country has attempted before,” said Collins. The cohort will take three or four years to assemble and will then be followed over several years. The goal is a diverse representation of individuals so the data can be used to expand the success Precision Medicine has already had with some cancers but also increase understanding preventive care for diabetes, obesity, mental illness and other conditions.

Collins said participants will be true partners involved in every step, data sharing will be swift to both researchers and participants, privacy and security principles will be held to the highest standards and they will make sure the information people receive about themselves is meaningful and clinically valid.

By the summer, the remaining components, he said, will be put into place. That includes establishing a coordinating center, a network of healthcare provider organizations that will engage and enroll individuals for data collection. He said a large number of provider organizations already have applied to the network. A biobank also will be established to store and manage biological specimens as well as a participant technology center to harness the latest in mobile phone and sensor technology.