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

Together We Make the Difference: National Strategy for Recruitment and Participation in Alzheimer’s and Related Dementias Clinical Research (PDF, 750K), released by the National Institute on Aging in 2019, outlines practical, proactive approaches to help study sites engage a wider, more diverse number of volunteers.

This National Strategy was developed with facilitation by the Alzheimer’s Association, and the expertise and insights of a collaborative of government, private, academic, and industry stakeholders, as well as from individuals, caregivers, and study participants.

The strategy focuses on four larger themes:

Increase awareness and engagement at a broad, national level
Build and improve capacity and infrastructure at the study site level
Engage local communities and support participants
Develop an applied science of recruitment

Background

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, enumerating goals and strategies for stepping up recruitment to support the success of research, including clinical trials.

This action toward a comprehensive, unified National Strategy was 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 with an aim to better understand and eventually cure these disorders can successfully and more quickly enroll and retain individuals.

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 Efforts Team:

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