On Wed, September 2, 2020, the National Institutes of Health held a one-day workshop on Inclusion Across the Lifespan. Presenters discussed the inclusion of pediatric and older populations in clinical trials, and showcased ways that the NIH is promoting age-based inclusion to the scientific community.
According to the NIH Inclusion Across the Lifespan webpage:
“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.”
The 2020 follow-up workshop examined the methodology of inclusion, providing a look at evidence-based approaches to meeting the IAL policy. The recording of this workshop is available for viewing.
Dr. Patti Brennan, Director of the NLM, spoke about policy implementation from the perspective of the National Library of Medicine. If you are interested in her talk, skip ahead to the 50-minute mark for about 25 minutes. Dr. Brennan began with discussing the importance of common data elements for interoperability between information systems. She spoke specifically about capturing age data in ClincalTrials.gov. Principle investigators must include age limits of potential participants in clinical trials. Minimum and maximum ages must be identified, as well as the unit of time to study this population.
As a result of these requirements, ClinicalTrials.gov is able to offer three options for filtering research by age: mean age; categorical age range (e.g. >65 years); and customized age range.
Dr. Brennan talked about the implications of accessing age-based data, for the research community as well as for the general public. She referenced an article from Cancer Medicine that looked at sponsorship of clinical trials relevant to the pediatric population which found that “[i]nterventional oncology trials that include patients < 18 years are less likely to be industry-sponsored compared to oncology trials exclusively in patients ≥ 18 years.”
For the general public, this New York Times article raises concerns about excluding older adults from clinical trials for COVID-19 treatments and vaccines. The NYT article examines the complexity of controlling for confounding variables while developing treatments that will be safe and effective to at-risk populations.
To learn more, here is the NIH Inclusion Across the Lifespan policy.