Alzheimer's Disease Patient and Caregiver Engagement
What Matters Most Research Resources
AD PACE is a ground-breaking patient and caregiver-led collaboration of industry, academics, government agencies and advocates building a persistent platform to deliver new insights to research, regulatory and payer authorities on preferred treatment and health outcomes sought by those living with Alzheimer's and their caregivers.
AD PACE will
- deliver a wide-ranging, scientifically rigorous understanding of what matters most to individuals across the breadth of the Alzheimer’s lived-experience;
- match the scope and pace of the development of FDA patient engagement guidance and policies;
- become an authoritative 'patient voice' to inform product and clinical trial design, regulatory submissions, payer value models, coverage and payment determinations, and research on care and services;
- initially be focused in the U.S. but collaborate with global partners.
As used in AD PACE, “patients” is intended to refer broadly to all persons living with or at risk for Alzheimer’s.
Patient-focused drug development (PFDD) is based on the premise that treatments should be designed to meet the needs of patients. By implication, PFDD requires that clinical trials demonstrate not only the effect of a drug on clinical outcomes, but also that those outcomes are meaningful to patients.
It is essential that the Alzheimer’s treatments and care and services are designed to meet the needs patients and caregivers. Today, there is little scientific research on what matters most to those with and at risk for Alzheimer’s and their caregivers. Given this, drug developers cannot be assured that new therapies in the pipeline for Alzheimer’s will deliver the meaningful outcomes that those affected by Alzheimer’s seek and hope for. AD PACE is aimed at meeting this need.
Identifying and quantifying treatment-related needs, preferences, and priorities will also provide value beyond therapy development. This knowledge will be developed in a manner so that it will also inform payment and coverage decisions as well as the design of care and services. AD PACE, through rigorous research, will define what is important to patients and caregivers and will share these results with researchers, policymakers, regulators, such as the Food and Drug Administration, and payers. We will advocate for the use of this information to assure that therapies deliver clinically meaningful outcomes and that payers take this knowledge into consideration when considering what is valuable to beneficiaries. AD PACE will also develop an enduring survey instrument that can be easily accessible to stakeholders, used to replicate results by researchers outside of this initiative, and expanded to understand differences among various sub-populations and for cross-sectional and longitudinal studies.
In November 2017, AD PACE officially launched with the help of its Founding Sponsors: UsAgainstAlzheimer’s, Leaders Engaged on Alzheimer’s Disease (LEAD), Biogen, Lundbeck, Otsuka America Pharmaceutical, and HomeInstead Senior Care; with Supporting Sponsorship from Eli Lilly and Company; and Partnership Support from patients and caregivers, the Dementia Action Alliance, Balm in Gilead, Alzheimer’s Research United Kingdom, and researchers from leading academic centers, including Columbia University, Cleveland Clinic, UC Irvine, and the University of North Carolina.
As a patient and caregiver-led initiative, AD PACE relies on leading voices across the Alzheimer’s community: those living with and at risk for Alzheimer’s, Alzheimer’s caregivers, patient representatives, and Alzheimer’s advocacy organizations.
AD PACE expresses its appreciation for the key roles that representatives from Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare/Medicaid (CMS) continue to play in providing advice and expertise to this initiative.
In addition, AD PACE wishes to recognize those who contributed resources, both financial and through in-kind leadership, to the early AD PACE Design Phase. Without the efforts of these groups, AD PACE would not have become a reality: Axovant Sciences, Biogen, Eli Lilly and Company, Janssen Pharmaceuticals, Lundbeck, Otsuka America Pharmaceutical, Roche, LEAD and UsAgainstAlzheimer’s, together with leadership from these federal agencies: FDA, NIH, CMS and HHS.
Ideation Workshop Plenary Sessions
UsA2 Voices of Alzheimer’s Program
Our vision is that rigorous data on what matters most to people living with dementia and care partners – the science of us – drives policy, research, drug development and access decisions affecting their lives. This program, which includes AD PACE and the A-LIST, develops patient and caregiver insights and experience data to inform advocacy, research, regulatory approvals, access determinations, care and services. This work will offer new knowledge to the field generally and advance drug development.