Trans-America Consortium of the Health Care Systems Research Network for the All of Us Research Program

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Clinicians throughout history have worked to tailor both prevention and treatment strategies to the individual patient’s needs; it is a fundamental credo to the practice of medicine. However, the vast majority of evidence-based clinical practice is based on research results acquired from measuring the common treatment effect on the “average person” in a restricted patient population with limited data, which we now know does not necessarily apply to numerous patients in the real-world setting. Thus, some patients will benefit from evidence-based treatments and preventative interventions, while others will be harmed by taking medications or undergoing processes and procedures that are at best non-effective and at worst cause serious side effects. However, since the initiation of pharmacogenomics in the mid-90s, the astounding pace of development of the technical and analytic tools to measure individual inherited and acquired biological variations at all physiological levels, as well as efficiently capture a patient’s medical and risk factor history and personal preferences via electronic means, is at a scale never before known.(PMIDs: 26554403, 26804248,26802434,26686739, 26769233, 26702339, 26700443, 26764593, 25231862) The current concept of “Personalized Medicine” or “Precision Medicine” in which these tools can be deployed to sharply hone predictions about an individual’s risk for disease or response to treatment, while still in its infancy, has immeasurable potential.(PMIDs:20551152,26014593,26810587) Further, the costs for next generation sequencing are expected to continue to decline as technology advances. (PMIDs: 24217348, 26195686) As resources are becoming increasingly constrained, it is important to devote scientific time, energy and dollars to questions that matter to the community and have strong potential for effectively improving medical care, public health and wellness. Hence the need, creation, and continuing development of the All of Us Research Program (AoURP). (http://www.pmwcintl.com/francis-collins-nih-qa/) The promise of Precision Medicine in the U.S. can be most effectively realized on a large scale in the next decades if a research infrastructure is established and accessible to scientists across the nation and includes a large and engaged study population with comprehensive health and lifestyle histories linked to biospecimens. Critically, this population must be diverse, representing minority and other subgroups underrepresented in biomedical research. (PMID:23571593) Further, as our investigators and others have recently published, the need to engage all stakeholders, including patients and providers, into both the research and “integration into practice” aspects of Precision Medicine as it progresses, is widely recognized. (PMID:27787499, 27669484, 20805700, 22962560,23780455, 24030437,26195686) Our Consortium objective is to recruit 93,000 participant partners into the AoURP, with a focus on African Americans, Arab Americans, Hispanics, rural residents, persons of low socioeconomic status (SES) and children, with the ability to target other groups of interest as needed. Now that we are rapidly ramping up engagement efforts in preparation for AoURP national launch, we will capitalize on an influx of appropriate resources and our experience in engaging, recruiting and retaining large numbers of participants in epidemiological and clinical cohorts, along with our patient-centered and process improvement approaches, to efficiently maximize recruitment and retention in the AoURP. Specific Aim 1: Provide the multi-site infrastructure to fully enroll and follow 93,000 Participant Partners (over-representing UBR populations) in the All of Us Research Program.