Inclusion Across the Lifespan Workshop

Date 06/01/17 8:00am to 06/02/175:00pm
Location Natcher Conference Center (Bldg. 45) Room E1/E2, NIH Main Campus
Event URL http://videocast.nih.gov
Description

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.  The workshop will bring together experts in clinical research to discuss barriers and opportunities for participation of these populations in clinical studies, including those supported by NIH.

The workshop will be held on the NIH campus June 1-2, 2017, with limited space available for in-person participation. The registration website will open in the next several weeks. For those who are unable to attend in person, the plenary sessions will be videocast so that interested individuals may view the presentations and reports. The videocast will be found here: www.videocast.nih.gov

The workshop will be addressing several topics, including:

  1. What are the inclusion/exclusion criteria that may impact pediatric and older populations in clinical trials?  What are the barriers to and the opportunities for inclusion of pediatric and older populations in clinical studies?
  2. What are the best study designs to ensure the inclusion of a broad range of ages, sex/gender, and race/ethnicity in a clinical trial or clinical study?  What strategies are successful to ensure all ages are included when appropriate?
  3. What are the ethical challenges when including those individuals under 18 years of age or frail/cognitively impaired older adults in trials? What are strategies to expand current successful practices for inclusion of these populations? When is it ethically justifiable to exclude vulnerable populations?
  4. Do NIH review criteria and peer review instructions designed to improve rigor and reproducibility (R&R) adequately address design, sampling and data analysis issues relevant to age-specific and subgroup analyses for clinical trials?  What age-related individual level data and/or summary statistics could reasonably be provided as part of standard clinical trial reporting for NIH applicants, grantees, and clinicaltrials.gov reports?
  5. What would be most helpful for interpretation of clinical study results -  age groups, mean age with SD, median age with SD, or some other metric? What approached to standardized reporting of age-related enrollment, data analysis issues, and results would be most helpful to moving the science forward?
  6. What other concerns should NIH consider related to the recruitment of pediatric and older populations into clinical studies?

Registration for in-person attendance will be required.  To watch the workshop online, visit http://videocast.nih.gov.  Sign language interpreters can be provided. Individuals with disabilities who need reasonable accommodation to participate in this event should contact Dr. Jaron Lockett, lockettj@mail.nih.gov, 301-451-8391, or the Federal Relay, 800-877-8339.

 

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