Research for the People by the People

This month's Perspective is personal. It comes from my great lifetime passion to see people's needs met as a primary activity of biomedical research. In my recent TEDMED talk featured on TED (Terry, 2017a), I made a passionate plea for the central role of people in research, for culture change that would honor ordinary decency with regard to data sharing and collaboration, and for the lived experience of people to drive research. The talk has gone viral, it has been viewed by almost a million people. My story touches a basic human chord: “nothing about us without us,” I have heard my Native American friends say. It makes sense to people that their experience be respected, that the information and samples they contribute are used as much as possible, and that collaboration be the main pillar of research. However, as is evident, this is not the status quo.

For many years, I have been involved in a national clinical research network focused on questions that matter to people and striving to create an evidence-based system for more relevant research done more efficiently. The Patient-Centered Outcomes Research Network (PCORnet) originated with funding from the Patient-Centered Outcomes Research Institute (PCORI). PCORnet has been actively pursuing people-centricity as a norm in the conduct of research. Although many entities are striving for this goal (Terry, 2017b), there remains a great deal of work until research with true engagement is commonplace. PCORnet seeks to transform the culture of clinical research by creating a system driven by the shared needs of people and their families, communities, clinicians, and health system leaders.

Early in 2017, the People-Centered Research Foundation (PCRF, 2017) was established in a robust effort to sustain and expand PCORnet. I have had a key role in the establishment of the foundation, and have a great deal of hope that what we participants in research have worked for over all these years will come to fruition in the work of PCRF. Together we are ensuring PCORnet's vision and unprecedented work continue.

The PCRF is a not for profit, 501(c)(3) charitable organization committed to accelerating people-driven research that is faster, more user friendly for patients and providers, and less costly. Our mission is to engage patients, families, research participants, clinicians, scientists, and health system leaders in the design, conduct, dissemination, and implementation of research and analysis that lead to improvements in the health and well-being of individuals and populations and the performance of healthcare delivery systems.

Robert Califf, MD, is the PCRF chairman of the board. He is also vice chancellor for Health Data Science for Duke Health, and former commissioner of the Food and Drug Administration. His thought leadership on the role of people in the learning health system makes him a perfect choice to lead the board of this trailblazing organization (Califf et al., 2016). Dr. Califf just announced that Kathy Hudson, most recently deputy director for Science, Outreach, and Policy at the National Institutes of Health (NIH), is the first Executive Director of the Foundation.

One of the key tenants of PCRF is meaningful engagement of all stakeholders. Building on the PCORI Engagement Rubric, PCORnet's Engagement Committee established the Engagement Assessment Tool (2017) to help the multiple networks within PCORnet assess their own levels of meaningful engagement. The tool will be used by PCRF as a standard for engagement with all stakeholders—particularly research participants, their caregivers, and clinicians, in addition to researchers, health systems leaders, and others—to apply the same level of rigor to engagement that all other aspects of the research enterprise receive.

Dr. Hudson is an excellent choice to lead PCRF as it drives biomedical research into an age wherein people prioritize, design, and conduct research to more effectively and efficiently respond to their needs. She has an abundance of experience in incorporating participant perspective into research. Early on she led much of the policy work associated with the sequencing of the human genome. Keeping focus on the people who contributed genetic material, in an age wherein such considerations were not the norm, Dr. Hudson led a variety of workgroups and committees at NIH and beyond, in her position at National Human Genome Research Institute (NHGRI) where she served as Assistant Director from 1995 to 2002. Most significantly in those years, she did the heavy lifting to make the case to scientists, public policy experts, and lawmakers about the need for federal legislation to guard against genetic discrimination. This resulted, with collaborative efforts from patient groups, and leadership from Genetic Alliance, in the Genetic Information Nondiscrimination Act of 2008. This effectively opened the door for people to have access to important information that can make a difference in their health and in disease treatments.

In 2002, Dr. Hudson was tapped by the Pew Charitable Trusts to open the Genetics and Public Policy Center at Johns Hopkins University. There she continued to work on issues that matter to the people being served by science, especially those related to genetic testing and diagnostics—the field of which is primary interest to this journal's readership. Dr. Hudson was able to advance understanding and broker agreements between the various parties creating and manufacturing diagnostic tests, the FDA's oversight of those tests, and the needs of people in ordinary care. She helped to establish the Genetic Testing Registry (GTR) at the National Center for Biotechnology Information (Vorhaus, 2010), a great step in creating more transparency around genetic tests for both providers and users.

Her work on GTR bridged into her return to NIH as first Chief of Staff and then Deputy Director for Science, Outreach, and Policy. In these positions, she continued her “people-first” leadership, and was a key architect in the design and launch of the Precision Medicine Initiative, the goal of which is to gather information and biological samples from a million or more people, with the needs of those people, and the responsibility to treat them as partners, central. Throughout her time at NIH, which just concluded in December 2016, she was adamant that data should be shared, that participants in research must be partners, and she found ways to make that happen.

Dr. Hudson joins a network filled with passionate people, phenomenal resources, and strong vision for putting people at the center. In addition, we in PCORnet and now PCRF are not just vision and talk. We have executed on a large number of basic infrastructure elements, done the hard work of testing and refining those elements, and implementing them. Governance policies, Common Data Model, the Engagement Assessment Tool, a Commons for sharing information and resources, Collaborative Research Groups, and several demonstration projects have been established. Dr. Hudson's leadership will drive us, and the U.S. biomedical enterprise, into an age wherein people's needs are central, and they are treasured for all they have to offer. I have great hopes for what we will accomplish together.

If not now, tell me when.

We may never see this moment

Or place in time again.

If not now, if not now, tell me when.

—By Carrie Newcomer Copyright © BMG Rights Management US, LLC.