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National Strategy for Recruitment and Participation in Alzheimer's Disease Clinical Research

National Strategy Development: A Collaborative Effort

In 2016, the National Institute on Aging (NIA) at NIH intensified efforts to outline practical, proactive approaches to help study sites and researchers recruit and retain adequate numbers of diverse volunteers for a growing number of studies in Alzheimer’s disease and related dementias. The Institute convened stakeholders to together develop a National Strategy for Recruitment and Participation in Alzheimer’s Disease Clinical Research (the “National Strategy”), enumerating goals and strategies for stepping up recruitment to support the success of research, including clinical trials.

The emerging National Strategy embraces the involvement of all who are interested in eradicating Alzheimer’s disease and related dementias. With a broad stakeholder and community undertaking in mind, the NIA, with facilitation by the Alzheimer’s Association, is seeking expertise and insights from a collaborative of government, private, academic, and industry stakeholders, as well as from individuals, caregivers, and study participants in development of the National Strategy and as we move into implementation.

This action toward a comprehensive, unified National Strategy is undertaken as part of the National Plan to Address Alzheimer’s Disease, from the standpoint of research, care and services that will make a difference for the growing numbers of adults with dementia and who are aging at risk. The research goal of the Plan calls for an expanded scientific effort, aimed at preventing and treating Alzheimer’s disease by 2025. Specific actions outlined in the National Plan related to recruitment seek to 1) increase enrollment in clinical trials and other clinical research through community, national, and international outreach, and 2) monitor and identify strategies to increase enrollment of diverse populations in Alzheimer’s disease studies. With development of a National Strategy, the community will also seek to develop ways to track activities and monitor progress.

Goal

The overarching goal of the National Strategy is to engage broad segments of the public in the Alzheimer’s and related dementias research enterprise, with a particular focus on underrepresented communities, so that studies can successfully and more quickly enroll and retain individuals in studies with an aim to better understand and eventually cure these disorders.This graph shows the circles of support surrounding patients participating in clinical research: influencers, infrastructure, and institutions.

Strategic Planning Process

Throughout 2017, small teams of experts began to pull together key components of a National Strategy, with a focus in three areas – National Efforts, Capacity Building, and Local/Diverse Connections. They have been guided by a participant-centered approach:

Steps and a timeline for finalizing the National Strategy include:

  • Alzheimer’s Association hosted stakeholder meeting at AAIC 2016 in Toronto
  • NIA hosted larger stakeholder group in Bethesda, MD, December 2016
  • Steering Committee of volunteers established, January 2017
  • Alzheimer’s & Dementia hosted a webinar on development of the strategy, February 2017
  • Topic leaders for strategy working groups identified, February 2017
  • Working groups began discussing and drafting strategy, March 2017
  • NIA hosted meeting of working groups to discuss initial drafts, April 2017
  • Goals and ideas were refined, May-December 2017
  • Wide public comment sought on National Strategy components, March-April 2018
  • National Strategy finalized, Summer 2018
  • Implementation planned for second half of 2018, incorporating efforts already underway and new initiatives

Steering Committee and Strategy Teams

Experts listed below have donated their time and expertise to initial development of the National Strategy.

Steering Committee

  • Paul Aisen, M.D., Alzheimer's Therapeutic Research Institute, University of Southern California
  • Vicky Cahan, NIA
  • Maria Carrillo, Ph.D., Alzheimer's Association
  • Meryl Comer, Geoffrey Beene Foundation
  • Susan De Santi, Ph.D., Piramal Imaging
  • John Dwyer, J. D., Global Alzheimer's Platform Foundation
  • Jessica Langbaum, Ph.D., Banner Alzheimer’s Institute
  • Laurie Ryan, Ph.D., NIA
  • Nina Silverberg, Ph.D., NIA
  • Heather Snyder, Ph.D., Alzheimer's Association
  • Eliezer Masliah, M.D., NIA
  • George Vradenburg, J.D., USAgainstAlzheimer's

Working Groups

National Efforts

Focus:Policies and activities at the national level that help identify and support strategies for successful recruitment and retention.

National EffortsTeam:

  • Jason Karlawish, M.D., Penn Memory Center at the University of Pennsylvania Chair
  • Malaz A. Boustani, M.D., MPH, Sandra Eskenazi Center for Brain Care Innovation, Indiana University
  • Vicky Cahan, NIA
  • Maria Carrillo, Ph.D., Alzheimer's Association
  • Joshua Chodosh, M.D., MSHS, FACP, NYU School of Medicine
  • Josh Grill, Ph.D., University of California, Irvine Alzheimer’s Disease Center
  • Amy Jordan, Ph.D., Annenberg School for Communication, University of Pennsylvania
  • Rachel L. Nosheny, Ph.D., Brain Health Registry, University of California San Francisco
  • Itzhak Yanovitzky, Ph.D., Rutgers University

Capacity Building

Focus: How study sites and multi-site networks do business and how they can be most effectively structured and staffed for the number and types of clinical studies currently underway and yet to begin.

Capacity Team:

  • Pierre Tariot, M.D., Banner Alzheimer’s Institute Chair
  • Jeffrey Burns, M.D., M.S., University of Kansas, Alzheimer’s Disease Center
  • Keith Fargo, Ph.D., Alzheimer's Association
  • Lynn Hughes, B.Med.Sci., Ph.D., PMP, QuintilesIMS
  • Jamie Roberts, MPH, MA, CCRP, Duke University
  • Laurie Ryan, Ph.D., NIA
  • Stephen Salloway, M.D., M.S., Brown University Medical School
  • Chris Van Dyck, M.D., Yale University Alzheimer’s Disease Center

Local, Diverse Efforts

Focus: Connecting at the local level, identifying and implementing best practices to build trusting relationships with communities and individuals toward the shared goal of making a difference for people and families affected by Alzheimer’s and related dementias.

Local, Diverse Team:

  • Laura Baker, Ph.D., Wake Forest University Alzheimer’s Disease Center Chair
  • Debra Buchwald, M.D., Washington State University
  • Debra Clark-Jones, Dioko Strategies
  • Gina Green-Harris, M.B.A., University of Wisconsin School of Medicine and Public Health
  • Jonathan Jackson, Ph.D., Massachusetts General Hospital
  • Olivia Mastry, J.D., MPH, ACT on Alzheimer’s
  • Stephanie Monroe, J.D., AfricanAmericansAgainstAlzheimer’s Network
  • Jason Resendez, LatinosAgainstAlzheimer's Network
  • Nina Silverberg, Ph.D., NIA
  • Heather Snyder, Ph.D., Alzheimer's Association