When you grow up in a family of 10 kids, like I did, your birthday is a very special day. My mom and dad made sure that it was always a celebration, with breakfast pancakes, a picnic lunch in the park, and favorite foods for dinner. It’s a day that’s just yours. By now, I’ve had more than 65 birthdays, and I have to say, each one is better than the last!
Like most people, I find that birthdays are a time for reflection, when you can pause and pinpoint where you are in the arc of your life. As a kid, it was a time of pure pleasure; as an adolescent, I wanted to be further along that arc. In midlife, I think I’m where I’m supposed to be, because I feel like I’m 39, think I look like I’m 49, believe I have a career worthy of someone who’s 59, and am approaching the wisdom of someone who’s 69. And although my reflections — both my thoughts and my likeness in the mirror — have changed over time, they all still reside within me, and every stage of my life informs each moment of my present.
NIH also recognizes the value of the various life stages and their potential contributions to clinical research. Generating new knowledge for health through biomedical research stands to have the greatest impact if individuals from across the lifespan are included, as appropriate, in a study.
This idea was deemed so important that NIH released the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects. In essence, this Inclusion Across the Lifespan policy states that individuals of all ages, including children (i.e., individuals under the age of 18) and older adults, must be included in all human subjects research conducted or supported by NIH unless there are scientific or ethical reasons not to. NIH is also hosting a virtual workshop, NIH Inclusion Across the Lifespan II, in September to review the lessons learned from this policy and examine evidence-based techniques for meeting the needs of this policy in research.
This commitment encourages individuals at all life’s stages and of all ages to participate in clinical research, as appropriate, where innovations and therapeutics are being created, tested, and evaluated. As a result, we’ll learn more about the effectiveness of new medicines on children or why some older adults maintain robust physical function well into their 90s, and participants will benefit from being involved in leading-edge research.
Along with requiring the inclusion of participants from across the lifespan in research studies, NIH also requires that summary results of those studies be made available to the public. Submission of the complete results for any clinical trial to ClinicalTrials.gov must include information on the age of the enrolled participants overall and in each study arm. (A study arm is a group of people in a clinical study who receive a specific drug, medical device, or other intervention.) Age may be listed as categorical variables (data that can be divided into discrete groups such as children, adults, and older adults) or as a summary statistic, such as mean age with a standard deviation or median age with minimum and maximum values.
As we include individuals from across the lifespan in research, it’s important to be clear about which variables are being tested or measured. One way that NIH supports this is by encouraging researchers to employ similar concepts and terms across a range of research programs, for example, by using common data elements in clinical research, patient registries, and other human subjects research, in order to improve data quality and opportunities for comparison. NLM hosts NIH’s Common Data Element (CDE) Resource Portal, which provides access to information about NIH-supported CDEs, as well as tools and resources to assist investigators in developing protocols for data collection.
NIH’s focus on age in research endeavors is yielding positive results, and I’m happy to be able to share articles from NLM’s own PubMed collection that highlight research addressing various age groups. Here are a few specific to older adult populations:
- Covid-19 and Immunity in Aging Populations – A New Research Agenda by Wayne C. Koff and Michelle A. Williams
- Age, Complexity, and Crisis – A Prescription for Progress in Pandemic by Louise Aronson
- Enabling Healthful Aging for All – The National Academy of Medicine Grand Challenge in Healthy Longevity by Victor J. Dzau, et al.
And here are several specific to the pediatric population and those under age 18:
- Systematic Review of COVID-19 in Children Shows Milder Cases and a Better Prognosis Than Adults by Jonas F. Ludvigsson
- National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations by Steven P. Broglio et al.
At this point in my life, I’m pleased to know that NIH and the National Library of Medicine supports science that is inclusive of populations across the lifespan, as well as literature and other accounts that record and make available the results of this type of research!
In the future, we will not only have a better understanding of what makes someone healthy or responsive to treatment at a given age, but we’ll be better able to use health data collected in the early stages of life to predict outcomes in older populations.
This scientific crystal ball will benefit all of us. What would you like to ask it?