Issued by
National Institutes of Health (NIH)

Purpose

In response to scientific need and a congressional mandate in the 21st Century Cures Act (P.L. 114-255), on June 1-2, 2017, the National Institutes of Health (NIH) convened a workshop on the appropriate inclusion of pediatric and older populations in research studies involving human subjects. The workshop brought together experts in clinical research to discuss augmenting participation of these populations in NIH-funded clinical studies. The NIH is publishing this Notice to solicit input concerning a planned follow-up NIH workshop on implementation of the new Inclusion Across the Lifespan policy regarding the recruitment and retention of pediatric, geriatric, and other underrepresented participants in clinical studies. The NIH welcomes comments from all interested stakeholders, including the scientific community, patients, caregivers, advocacy organizations, and other members of the public.

Background

In January 2019, NIH implemented a new policy on Inclusion Across the Lifespan aimed to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. NIH is holding a follow-up workshop to the original 2017 Inclusion Across the Lifespan workshop (IAL workshop summary) to examine the implementation of the NIH policy and discuss remaining opportunities for and barriers to inclusion. The Inclusion Across the Lifespan II (IAL-II) workshop will be held on the NIH campus September 2-3, 2020 and videocast at https://www.videocast.nih.gov.

The purpose of the IAL-II workshop is to discuss both lessons learned from the scientific community regarding the implementation of policies addressing the inclusion of pediatric and older adult populations in clinical studies as well as evidence-based practical advice on how to optimize recruitment of these underrepresented populations in clinical research.

The IAL-II workshop will review inclusion at all phases of clinical study development and execution, with a focus on pediatric and geriatric populations. The workshop will have an added focus on underrepresented populations (e.g., sex/gender minorities, racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, and others who are not well- represented in clinical research) across the life course. There will be an emphasis on similarities as well as contrasts among the populations with regards to facilitators/barriers to their participation in clinical studies.

Information Requested

The NIH is interested in soliciting comments and suggestions from a range of stakeholders, including the scientific community, patients, caregivers, and advocates, regarding topics to be covered in the IAL-II workshop regarding the inclusion of pediatric, geriatric, and other underrepresented populations in clinical research. This Notice will remain open until February 15, 2020.

The NIH is Interested in Responses to the Following Topics:

Challenges and barriers to enrollment of individuals of all ages in clinical research studies.

Challenges and barriers to collection and reporting of participant-level data, including age at enrollment.

Implementation strategies that address potential ethical challenges when including individuals under 18 years of age, frail or cognitively impaired older adults, and other vulnerable populations in clinical trials or clinical studies.

Strategies and special considerations for including other underrepresented populations in clinical study designs that were not specifically addressed in the first workshop (e.g., sex/gender minorities, racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, people with comorbidities, and others who are not well represented in clinical research).

Development, implementation, and dissemination of scientifically appropriate and ethical inclusion and exclusion criteria for clinical trials or clinical studies.

The effect of developmental/aging stages on responses to biomedical and behavioral interventions, and strategies to tailor study planning and implementation to life stages.

How to overcome barriers to inclusion in clinical studies related to comorbidities, impairments, and disabilities.

Practice- or evidence-based strategies and necessary adaptations in recruitment/retention methods, modified safety monitoring, and how to use life stage-specific and patient-oriented outcomes in clinical trials or clinical studies.

Opportunities for education and outreach to clinical researchers, community physicians, and their patients about the importance of participation in research.

Strategies to disseminate and support the adoption of proven implementation techniques and strategies that overcome barriers and maximize the inclusion of a broad range of ages, sexes/genders, races/ethnicities, and other underrepresented participants in clinical trials or clinical studies.

Any other issues or concerns that NIH should consider regarding the implementation of optimal study designs that ensure the inclusion of participants across a broad range of ages and underrepresented groups.

How to Submit a Response

Responses will be accepted until February 15, 2020. All responses must be submitted via email to [email protected]. Please include the Notice number in the subject line and include your complete contact information with your response. All submissions will be considered. Submitted information will not be considered confidential and is considered public information. Please do not include any proprietary, classified, confidential, or sensitive information in your response.

Inquiries

Please direct all inquiries to:

Samir Sauma, Ph.D.
Director
Office of Planning, Analysis, and Evaluation
National Institute on Aging
Telephone: 301-496-3121
Email: [email protected]