Inclusion Across the Lifespan
Natcher Conference Center
NIH Building 45 Room E1/E2
Please participate in the Request for Information seeking comments on inclusion in clinical research across the lifespan by June 30, 2017.
The NIH workshop “Inclusion Across the Lifespan” seeks to examine the science of inclusion of various populations in clinical trials and studies. The workshop will place a particular focus on the pediatric and older populations, as these populations have very specific and unique health issues that must be examined as new interventions are being studied and ultimately inform healthcare. The workshop is also in response to the 21st Century Cures Act that was passed in December 2016, which states that the NIH “shall convene a workshop of experts on pediatric and older populations to provide input on— 1) appropriate age groups to be included in research studies involving human subjects; and 2) acceptable justifications for excluding participants from a range of age groups from human subjects research studies.” Therefore, this is an exciting time for the NIH to carry out this workshop and examine the inclusion of different age groups in clinical research.
Experts in relevant fields will gather to discuss how different age groups are included in clinical research and clinical trials and studies. The following topics will frame the discussion:
- Inclusion/Exclusion criteria and their impact on inclusion in clinical trials and studies
- Study designs and metrics for pediatric and older populations in clinical trials and studies
- Ethical challenges and the enrollment of vulnerable populations
- Data collection and reporting to support age-specific and subgroup analyses
The workshop will be held on the NIH campus in Bethesda, MD on June 1, 2017 from noon to 5:30 p.m. and on June 2, 2017 from 8:30 a.m. to noon. The primary audience will be representatives from research institutions, private foundations, advocacy groups, and various government agencies, including NIH staff and researchers. The workshop will inform recommendations to shape the science of inclusion in NIH-funded clinical trials and studies.