Final report and presentation also included.
On January 20, 2015, President Obama launched a new U.S. initiative, the Precision Medicine Initiative (PMI), to accelerate our understanding of individual variability and its effect on disease onset, progression, prevention, and treatment. There are two components to the PMI, one focused on expanding current efforts in cancer genomics and testing methods for prevention and treatment of cancers in a more precise way; this component will be managed by the National Cancer Institute. The second is to create a large research cohort of one million or more participants who choose to share many types of data (e.g., biomedical, behavioral, and lifestyle) to advance research. The creation of this research cohort will provide unprecedented opportunities to discover and quantify factors that contribute to illness, and to test approaches that can preserve health and treat disease.
In the fiscal year 2016 budget, the President proposed that $215 million be devoted to the PMI. Of this, $130 million will be used to start building the PMI research cohort. To help plan for the creation and management of the PMI research cohort in fiscal year 2016 and beyond, a working group of the Advisory Committee to the NIH Director (ACD) will be established. This group includes experts from many disciplines and sectors.
The ACD Working Group on the Precision Medicine Initiative will develop a vision for how to harness the advances in technology, scientific understanding, and participant engagement to develop a platform for precision medicine research. To ensure that the Working Group's contributions can be incorporated into the funding plan for fiscal year 2016, in the short term, this group will develop a plan for creating and managing a large research cohort with data and specimens that can be accessed by all researchers for studies to understand the variables that contribute to health and disease and ultimately translate that knowledge into treatments tailored to individuals. A report will be delivered to the ACD in September 2015.
In developing the report, the Working Group will:
Articulate the vision for the PMI research cohort, including what can be learned from a study at this scale and what success might look like five and ten years out.
- Detail the issues that will need to be examined in developing the study design.
- Consider how to incorporate rapidly evolving technology into the cohort design
- Develop criteria for the inclusion of mobile health technologies into the cohort, both for baseline and ongoing data collection.
- Outline a path forward for getting the EHRs associated with the cohort interoperable or for standardizing data that can be extracted in response to a query.
- Consider what laboratory components can be incorporated, including various — omics and imaging approaches
- Assess ways to recruit visionary experts from multiple disciplines to join the PMI, including potential support of pilots to test new ideas and new technologies
- Identify the pros and cons of different models for enrolling participants into the cohort, including consideration of methods for ensuring that underserved populations are included.
- Review existing models of participant engagement and recommend a path for establishing the best strategy for ensuring participants are involved in the planning, building, and management of the cohort.
- Identify any gaps in existing policies on data privacy, security, and misuse that must be filled to support the PMI cohort, and propose a route to develop appropriate solutions.
- Recommend approaches to work with the International community, both for learning as we build the cohort and for possible collaborations.
- Describe methods for evaluating the success and utility of the cohort for all parties — participants, researchers, healthcare providers, funders, etc.
In carrying out its charge, the working group will need to engage with many individuals from different disciplines and backgrounds — through public meetings on issues critical to the design and vision for the cohort.ta science challenges facing the biomedical research enterprise.