Notice Number: NOT-OD-17-059

Key Dates
Release Date: April 26, 2017
Response Date: June 30, 2017

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), the National Institutes of Health (NIH) is convening a workshop of experts on the appropriate inclusion of pediatric and older populations in research studies involving human subjects. A workshop will be held on June 1-2, 2017, to bring together experts in clinical research to discuss augmenting participation of these populations in NIH-funded clinical studies. In addition, the NIH is publishing this Notice to solicit input from the wider scientific community and welcomes comments from the public concerning inclusion in research.

Background

The 21st Century Cures Act states in part:

Appropriate Age Groupings in Clinical Research
1) Input from Experts Not later than 180 days after the date of enactment of this Act, the
Director of the National Institutes of Health shall convene a workshop of experts on pediatric
and older populations to provide input on

A) Appropriate age groups to be included in research studies involving human subjects: and
B) Acceptable justifications for excluding participants from a range of age groups from human subject research studies.

Further, the NIH Director is charged to, taking into account the input received through the workshop, decide whether any changes to NIH policies are needed.

The workshop, held on the NIH campus June 1-2, 2017, will be videocast so that any interested individuals may view the presentations and reports. The videocast can be found here: www.videocast.nih.gov.

Information Requested

The NIH is interested in soliciting comments and suggestions from the scientific community regarding the topics that will be discussed during the workshop. This Notice will remain open until June 30, 2017.

The NIH is interested in responses to the following topics:

• Best study designs that ensure the inclusion of participants from a broad range of ages, sex/gender, and race/ethnicity in clinical trials or clinical studies.
• Strategies that are successful to ensure all ages are included when appropriate
• Potential ethical challenges when including those individuals under 18 years of age, or frail or cognitively impaired older adults in trials
• Ethical justification for excluding vulnerable populations
• Strategies to expand current successful practices for inclusion of these populations.
• Age-related individual level data and/or summary statistics that could reasonably be provided as part of standard clinical trial reporting for NIH applicants, grantees, and clinicaltrials.gov reports
• Metrics that would be most helpful for interpretation of clinical study results - age groups, mean age with SD, median age with SD, or some other metric
• Approaches to standardized reporting of age-related enrollment, data analysis issues, and results that would be most helpful to moving science forward
• Potential barriers to and the opportunities for inclusion of pediatric and older populations in clinical studies
• Any inclusion/exclusion criteria that might have the unintended consequence of reducing enrollment of pediatric and older populations in clinical trials
• Any inclusion/exclusion criteria that might facilitate enrollment of pediatric and older populations in clinical trials
• Any other concerns that should NIH consider in the recruitment of pediatric and older adult populations into clinical studies

How to Submit a Response

Responses will be accepted until June 30, 2017 (30 days after the June 1-2, 2017 workshop). All responses must be submitted via email to Lisa Kaeser. Please include the Notice number NOT-OD-17-059 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.

Inquiries

Please direct all inquiries to:

Lisa Kaeser
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-0536
Email: kaeserl@mail.nih.gov