NIH Inclusion Across the Lifespan II
- About the Workshop
- Planning Committee & Support
- Panelist Bios
- Submit Feedback
The goal of the workshop is to provide lessons learned regarding the inclusion of pediatric and older populations in clinical studies, with evidence-based practical advice to the scientific community. The workshop will bring together individuals with a variety of backgrounds in clinical study development and execution, with focus on pediatric and geriatric populations, and consideration of special populations (e.g. racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, people with co-morbidities, sexual and gender minorities, and other groups), across the life course.
Due to the COVID-19 pandemic, the Inclusion Across the Lifespan-II workshop will be held virtually.
- The IAL-II workshop will be held virtually. Participants are encouraged to register for the virtual meeting. Please make sure your contact email is correct as links to join the meeting will be sent to that email.
- Check this page periodically for more information.
In 2017, in response to the 21st Century Cures Act, NIH held a workshop entitled “Inclusion Across the Lifespan” (IAL), which examined the barriers to and opportunities for inclusion of children and older adults in clinical studies. Discussions at the workshop contributed to NIH considerations in developing the IAL policy that went into effect in January 2019.
NIH is holding this follow up workshop on September 2, 2020 that will examine the science of the inclusion of these populations, providing researchers evidence-based approaches to meeting the new IAL policy. There will be a focus on pediatric and geriatric populations, and discussions will include considerations for special populations (e.g. racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, people with co-morbidities, sexual and gender minorities, and other groups).
Topic Areas and Agenda
- Topic Area 1: Inclusion/exclusion criteria
- Topic Area 2: Study design and metrics
- Topic Area 3 - Recruitment, enrollment and retention
- Topic Area 4 - Data analysis and study interpretation
|10:30-11:00 (EST)||Log on to WebEx|
Marie A. Bernard, MD
|Greetings from the NIH|
Francis Collins, MD, PhD
Michael Lauer, MD
Richard Hodes, MD
Diana Bianchi, MD
Janine Clayton, MD
Eliseo Perez-Stable, MD
Implementation of the IAL Policy - CSR & NLM
Noni Byrnes, PhD
Patricia Brennan, RN, PhD
Panel Discussions with Q&A
Topic Area 1: Inclusion/exclusion criteria
- Florence Bourgeois, MD, MPH, Harvard Medical School*
- Cynthia Boyd, MD, Johns Hopkins University*
- Lucile L. Adams-Campbell, PhD, Georgetown University
- William Dale, MD, Ph.D., City of Hope
- Celia Fisher, PhD, Fordham University
- George Saade, MD, University of Texas Medical Branch
Topic Area 2: Study design and metrics
- Jerry Gurwitz, MD, University of Massachusetts Medical School*
- Peter Peduzzi, PhD , Yale School of Medicine *
- Alyce S. Adams, PhD, Kaiser Permanente Northern California
- Danny Benjamin, MD, PhD, Duke Clinical Research Institute
- Supriya Mohile, MD, University of Rochester
Topic Area 3 - Recruitment, enrollment, and retention
- Michelle S. Hamstra, MS , Cincinnati Children's Hospital Medical Center *
- Steven Wallace, PhD, University of California-Los Angeles *
- Raegan Durant, MD, MPH, University of Alabama at Birmingham
- Wendy Kohrt, PhD, University of Colorado- Anschutz Medical Campus
- Mark Supiano, MD, University of Utah School of Medicine
- Consuelo Wilkins, MD, MSCI, Vanderbilt University Medical Center
Topic Area 4 - Data analysis and study interpretation
- Heather Allore, PhD Yale School of Medicine*
- Valentina Shakhnovich, MD, Children’s Mercy Kansas City*
- Karen Bandeen-Roche, PhD, Johns Hopkins Bloomberg School of Public Health
- Robert Golub, MD, Deputy Editor, JAMA
- Jay Magaziner, PhD, MSHyg, University of Maryland School of Medicine
Wrap-up and final comments
- James Griffin, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
- Barbara Radziszewska, PhD, National Institute on Aging, NIH
- Samir Sauma, PhD, National Institute on Aging, NIH
Wednesday, September 2, 2020
- 2017 Inclusion Across the Lifespan workshop summary
- 21st Century Cures legislation (PDF, 726k)
- Inclusion Across the Lifespan policy
- Revised: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects
- Inclusion across the lifespan: NIH policy for clinical research (JAMA article)
- Improving Public Health Requires Inclusion of Underrepresented Populations in Research (JAMA article)
- Adequacy of Inclusion of Older Adults in NIH‐Funded Phase III Clinical Trials (JAGS article)
Participants are encouraged to register in advance of the meeting. Registration is free of charge for all participants.
February 20 through September 1, 2020
Planning Committee Co-Chairs
- James Griffin, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Barbara Radziszewska, Ph.D., National Institute on Aging (NIA)
- Samir Sauma, Ph.D. , National Institute on Aging (NIA)
Planning Committee Members
- Dara R. Blachman-Demner, Ph.D., Office of Behavioral and Social Sciences Research (OBSSR)
- Dawn Corbett M.P.H. National Institutes of Health, Office of Extramural Research (NIH/OER)
- Elonna Ekweani, J.D., Office of Research on Women's Health
- Valery Gordon, Ph.D., M.P.H. National Center for Advancing Translational Sciences (NCATS)
- Joyce Hunter, Ph.D., National Institute on Minority Health and Health Disparities (NIMHD)
- Brian Johnson Ph.D., National Cancer Institute (NCI)
- Lisa Kaeser, J.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NIH)
- Katherine Kavounis, M.P.H., National Heart, Lung, and Blood Institute (NHLBI)
- Jaron Lockett, Ph.D., National Institute on Aging (NIA)
- Samia Noursi, Ph.D., Office of Research on Women's Health
- Mercy Prabhudas, Ph.D., M.B.A., National Institute of Allergy and Infectious Diseases (NIAID)
- Sheila Prindiville, M.D., M.P.H., National Cancer Institute (NCI)
- Susan Schafer, R.N., M.S., National Institute of Allergy and Infectious Diseases (NIAID)
- Katrina Serrano, Ph.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Erica Spotts, Ph.D. Office of Behavioral and Social Sciences Research (OBSSR)
This workshop is a trans-NIH effort supported exclusively with government funds.
The workshop will be videocast live on September 2, 2020. The video will be archived and available for viewing after the workshop.
Media inquiries surrounding the workshop should be directed to the NIA Office of Communications and Public Liaison or call (301) 496-1752.
Email the Planning Committee if you have general questions that are not answered on this website.
Sign-language interpreters can be provided. Individuals with disabilities who need reasonable accommodation to participate in this event should Email the Planning Committee, or the Federal Relay, 800-877-8339.