New chance to advance inclusion of all ages in research
NIH hosted its first Inclusion Across the Lifespan (IAL) workshop in 2017 (PDF, 817K) to examine the science of including various and diverse populations in clinical studies, particularly children and older adults. These two groups have very specific and unique health issues that must be examined as we study new interventions that ultimately inform healthcare.
As I mentioned earlier this year, NIH’s follow-up event, the Inclusion Across the Lifespan-II (IAL-II) workshop, will provide a forum to address this urgent topic. In response to the COVID-19 pandemic, the IAL-II will be held virtually on Sept. 2, 2020.
A bit of history
The 2017 workshop was mandated as part of the 21st Century Cures Act. The workshop’s discussions contributed to NIH considerations in developing the NIH IAL policy update requiring inclusion of individuals across the lifespan in clinical research studies unless there are scientific or ethical reasons to exclude them.
The IAL-II workshop will provide another crucial platform to share evidence-based practical advice and lessons learned regarding the inclusion of children and older adults in clinical studies. The agenda will include:
- An overview of phases of clinical study development and execution, with an emphasis on pediatric and geriatric populations
- Discussion about challenges and opportunities for inclusion of older and younger participants
- Consideration of other traditionally underrepresented and/or underserved populations such as 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
- Examination of the following topic areas to better understand the impact of the policy changes:
- Inclusion/exclusion criteria
- Study design and metrics
- Recruitment, enrollment, and retention
- Data analysis and study interpretation
Join the movement!
Although there is no fee, registration is required, and all attendees will be strongly encouraged to actively participate in the panels and discussion. Please register today to join the inclusion across the lifespan dialogue. We welcome your comments or suggestions. See you in September!