2 Comments
Make your comments and suggestions heard as NIH plans the follow-up to the 2017 Inclusion Across the Lifespan workshop, the Inclusion Across the Lifespan II (IAL-II) workshop that will focus on the recruitment and retention of pediatric, geriatric, and other underrepresented participants in clinical studies.
NIH is particularly interested in hearing about challenges to enrollment of individuals of all ages in clinical research studies and strategies for including other underrepresented populations that were not addressed in the first workshop (e.g., sex/gender minorities, racial/ethnic minorities, people with disabilities, rural/isolated populations, language minority individuals, pregnant and lactating women, and others who are not well- represented in clinical research).
Submit your comments via email to [email protected] before February 15, 2020. For more details, see the full Guide Notice.
I think this is a noble goal but in some ways unrealistic since the disease areas differ from children to adults, the outcome measures vary, and most of intervention techniques, for example, medications and available delivery devices can vary. IT is a challenge to harmonize all of these items to do a true lifespan study.
I was not part of the first workshop, so I am not sure if these issues were discussed. Having done a study in an age group that was 5 to 11 years and then 12 and older in the NIH AsthmaNet asthma network, we had to face these challenges and address them. See publication by Wechsler, NEJM 2019. Because of the differences in dose and delivery device formulations, it was difficult to make a comparison. Perhaps, studies that are broken down by age increments might be more realistic in providing useful clinical results, as per the FDA regulatory plan on looking at pediatric labeling.
Again the strategy will differ depending upon the question, as well as safety and ethical considerations.
…also, I should add to my prior comment that some study sites only see children and not adults and it would then be necessary to enroll multiple sites into the studies. For example a pediatric focused study at a Children’s Hospital would require the collaboration of an adult-oriented site to meet the lifespan requirements and that would add additional expense, study sites, quality control, etc.