The NIH Inclusion Across Lifespan-II Workshop is happening TOMORROW, starting at 11am Eastern.
For more information, visit the IAL-II website; in addition, we’ve provided some key details and links below.
To participate tomorrow, click here: https://videocast.nih.gov/live.asp?live=38384&preview=1.
Pre-recorded overviews of topic areas from some of the workshop panel co-chairs here: https://go.usa.gov/xGqGE.
Here’s an overview of the topics that will be covered:
Topic Area 1: Inclusion/exclusion criteria
- Pediatric perspective — Florence Bourgeois, M.D., M.P.H., Harvard Medical School | Watch the Topic 1 pediatric perspective video
- Older adult perspective — Cynthia Boyd, M.D., Johns Hopkins University | Watch the Topic 1 older adult perspective video
The study population defined by the eligibility criteria should be representative of the population of people with the condition being studied. The inclusion and exclusion criteria should be objective and written in clear, concise language, and investigators should provide a scientific justification for each criterion. The co-chairs will discuss this topic with specific considerations for the pediatric and older adult perspectives.
Topic Area 2: Study design and metrics
- Jerry Gurwitz, M.D., University of Massachusetts Medical School
- Peter Peduzzi, Ph.D., Yale University School of Medicine
PLEASE NOTE: Topic area 2: Study design and metrics does not have pre-recorded videos to view.
The study design and metrics of a clinical trial should be constructed in a way to be more inclusive across all ages, using input from the entire study population. Here we will examine challenges that investigators face when designing studies and how these challenges can impact clinical trials.
Topic Area 3: Recruitment, enrollment, and retention
- Pediatric perspective — Michelle S. Hamstra, M.S., Cincinnati Children’s Hospital Medical Center |Watch the Topic 3 pediatric perspective video
- Older adult perspective — Steven Wallace, Ph.D., University of California, Los Angeles | Watch the Topic 3 older adult perspective video
Ensuring appropriate representation of children and older adults in clinical trials goes beyond the inclusion criteria — additional consideration is needed to design effective methods to identify, enroll, and retain children and older adults in clinical studies and trials. The co-chairs will examine the pediatric and geriatric considerations for recruitment and retention with emphasis on special populations.
Topic Area 4: Data analysis and study interpretation
- Pediatric perspective — Valentina Shakhnovich, M.D.,University of Missouri-Kansas City School of Medicine | Watch the Topic 4 pediatric perspective video.
- Older adult perspective — Heather Allore, Ph.D., Yale University School of Medicine | Watch the Topic 4 older adult perspective video.
Appropriate data analysis and interpretation is critical to the synthesis of trial evidence and its application in treating patients. This includes careful consideration of certain sub-populations in the analysis, including children and older adults. The study of specific sub-populations must be considered throughout the process, beginning with study design, and extending to data analysis, interpretation, and dissemination. With increases in inclusion of children and older adults in clinical studies, it is critical to develop data analysis plans that ensure appropriate, relevant, and meaningful study conclusions.