Many of us began 2016 with a list of New Year’s resolutions that may or may not have lapsed by now. While some of us may need motivation to get back on track to achieve whatever goals we set, the National Institutes of Health (NIH) started the year with a daunting but very exciting task – to move the Precision Medicine Initiative Cohort Program (PMI-CP) ahead by recruiting one million or more Americans to be part of this large research cohort. The initiative and its many volunteers has the potential to be the platform to expand our knowledge of precision medicine approaches that can benefit the nation. Moreover, it may even change the way we prevent and treat many of the diseases that currently have no cure.
Last fall, a Working Group Report from the Advisory Committee to the Director of the NIH, which is made up of federal government, academic, research, non-profit patient advocates, health plan, and technology companies, put forth recommendations for the PMI-CP that were approved by the NIH. The recommendations serve as a blueprint for how the NIH can assemble and recruit the cohort over the next few years and recommend that any individual living in America be allowed to volunteer. The Advisory Committee outlines mechanisms to keep the cohort of volunteers engaged over time and recommends that they have the ability to set preferences around how much of their personal information they disclose. The Committee also details data considerations, including recommending electronic health records (EHRs) be a core data set in combination with data from health plans, participant surveys, mobile health technologies, and biologic investigations. Governance structure, policy considerations, and biobanking considerations are also outlined in the recommendations.
While health care system stakeholders have been discussing “patient-centered care” for years, this is an initiative that truly puts the patient at the center. But, it will not be easy. This begs the question, “Is the US ready for an undertaking of this magnitude?”
The Advisory Committee’s report says that there are a number of reasons for why the timing is right for the PMI-CP. There is widespread agreement that in health care, the status quo is not acceptable. The ongoing shift from a volume-based system to one that is based on value, the health information technology revolution that has led to major reductions in the cost of storing data and increases in analytical capabilities, and the widespread adoption of EHRs are a few examples of the current transformation happening in health care. Early adopters among health care consumers are going online, using social media, and engaging in mobile health – and the trend is growing every year. Other stakeholders have put increased focus on the value of patient-generated data to improve clinical research and care delivery. Perhaps most importantly, patients are ready for better and more treatments and cures.
Of course, there are challenges to overcome. Patients and consumers will likely have privacy and security concerns, and interoperability efforts are still nascent to date. It will be extremely important to communicate what the PMI-CP is, what potential it has to improve health outcomes and lead us to cures that have eluded us, and what expectations are from each stakeholder. The NIH will need to draw on the full network of health care stakeholders to overcome these challenges. Consumers and providers will be on the front lines of these efforts, and researchers, non-profit advocacy groups, government entities, policymakers, health plans, the life sciences industry, and technology companies will all have a significant role.
While it sounds daunting, I am confident that as a nation, we can make progress in 2016 and in the coming years. There are many models of diverse stakeholders coming together to share data we can draw from. For example, the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital has created an environment for stakeholders to share data to improve the way clinical trials are conducted around the world. Just last week, the Obama Administration requested $1 billion to fund the National Cancer Moonshot, an initiative to cure cancer. Improving data sharing and organization is a key component of the moonshot effort. Finally, we continue to see extended impact from the Human Genome Project, which demonstrated that the US is capable of achieving unprecedented milestones in sharing and analyzing vast amounts of data to benefit human health.
Now that the blueprint for the Precision Medicine Initiative Cohort Program has been set, we can continue the momentum of NIH-supported breakthroughs in basic science, clinical research, and translational medicine. The time is right for this initiative to advance the goal of getting targeted treatments and cures to patients.