NIH Inclusion Across the Lifespan-II Workshop
Date and Time–
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.
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. It 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. women, racial/ethnic minorities, sex/gender minorities, rural/isolated populations, others that are specific to that phase of life).
Topic Areas to be covered
- 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