Wanted: Blood, Urine, and a Soil Sample from Your Yard

Oct 03

The Precision Medicine Initiative is a bold new research effort to revolutionize how we improve health and treat disease.

The Precision Medicine Initiative is a bold new research effort to revolutionize how we improve health and treat disease.

What would it take to get you to participate in a government study in which you and 999,999 other people committed to providing personal health data and blood and urine samples for at least 10 years?

This summer, the National Institutes of Health (NIH) announced $55 million in awards to build the foundation and infrastructure needed to launch the Cohort Program of President Obama’s Precision Medicine Initiative (PMI). The PMI Cohort Program is a landmark longitudinal research effort that aims to engage 1 million U.S. participants to improve our ability to prevent and treat disease based on individual differences in lifestyle, environment, and genetics.

No other government study of its kind comes close to recruiting this many participants. For comparison, the government’s well-known, population-based Framingham Heart Study has enrolled 15,447 participants since it started in 1948. The PMI Cohort Program aims to recruit 79,000 participants in its first year.

A recent NIH survey showed that 54% of respondents would definitely or probably participate in the PMI Cohort Program if asked. While 79% of respondents supported the study, the two groups who were less inclined to participate were those with fewer years of education and those ages 60 and above.

The promise of precision medicine has grown as Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic analysis costs have dropped significantly, data science has become increasingly sophisticated, and health technologies have become mobile.

Although official recruitment for the program is not yet underway, NIH is using several key messages to encourage participation:

#1 – Precision medicine is an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. Doctors could eventually use the PMI Cohort Program data to shape treatment for an individual patient, rather than using standard treatments that may not work for everyone.

#2 – Anyone living in the U.S. will be able to participate in the PMI Cohort Program. Volunteers will be asked to share data including information from their electronic health records and health questionnaires. Participants will also undergo a standard baseline physical evaluation and provide blood and urine samples. Participants may be asked to provide health data on lifestyle habits and environmental exposures as well, from activity-tracking devices like Fitbit.

#3 – A foundation of diverse partners will ensure that the cohort is representative of our country’s diversity. NIH has selected four regional medical centers, six Federally Qualified Health Centers, and the VA as initial partners—improving the ability to reach large numbers of potential volunteers, which contributes to the overall diversity of the participants and regions reached by this phase of the program.

#4 – Personal health information won’t be held behind a veil of secrecy… Patients will have access to their own data so they can participate fully in decisions about their health that affect them. Officials say they want patients to be partners in the research, not just “human subjects.” To that end, patients will have access to all the information about themselves, including laboratory and genetic test results.

#5 – But it will be protected! Maintaining data security and privacy will be paramount to maintaining participants’ trust and engagement. The program will engage teams of privacy experts and employ rigorous security testing models, develop participant education with regard to privacy and potential re-identification risk, and clearly articulate response plans in the case of a privacy breach.

As NIH moves forward with the rollout of the PMI Cohort Program, I look forward to following how they manage a variety of related communications considerations:

  • Research to understand participant motivators. Will people respond best to messaging that puts them at the center of advancing medicine? Will they be driven by the opportunity to save others’ lives or improve their own condition? Answers to these types of questions will aide in developing clear, audience-based messages and materials.
  • Channel strategy. To recruit 1 million people, NIH is going to have to get creative about how it reaches people, while at the same time respecting the boundaries of IRB. The importance of an online presence goes without saying, but how will NIH use new and emerging social platforms for communications efforts? What channels will reach less educated and older Americans?
  • Crisis communications. Security breaches. Unexpected negative findings. When crisis hits—as it inevitably does—how will NIH respond? By having crisis-planning templates and checklists “at the ready,” NIH will be steps ahead in a crisis situation.
  • Media relations. A government program of this size will draw a significant amount of media interest. How can NIH recognize and take advantage of the media’s interest? What strategies will NIH use to maximize the reach of program results?

 

The PMI will enable a new era of medicine in which researchers, providers, and patients work together to develop individualized care. But its success depends on how NIH uses communications to recruit and retain participants, the strength and scope of the participant pool—and ultimately, how the data trove is used.

This entry was posted on Monday, October 3rd, 2016 at 6:05 pm and is filed under Public Health. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.

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