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Tremendous progress has been made in the management of human diseases through the development of new therapeutics and devices that were tested in clinical trials. However, pediatric and older populations may be excluded from these trials, and these exclusions limit the generalizability of study results to some age groups that bear a high burden of certain diseases and disorders. While greater than 60% of new cancer cases occur in elders, they represent less than 32% of participants in cancer clinical trials (1). Similar trends were found when clinical trials testing agents to treat many common diseases of elders were analyzed (2). For many years, the lack of children in clinical trials has been recognized (3,4). Despite efforts to increase inclusion of children in clinical trials and clinical studies, children still receive medications tested primarily in adults, as trials in children are more challenging.
It is likely that younger and older individuals respond differently to available therapeutics or that the spectrum of a disease will vary by age. While there may be safety concerns with the inclusion of children and frail and dependent elders in trials, convention is probably the reason for their exclusion from many studies. Artificial age restrictions or strict inclusion/exclusion criteria may have unknown impacts on the final sex/gender, race and ethnicity composition of a study population.
NIH recognizes the need to ensure the age range for a study of a given disease is scientifically appropriate so that study results are relevant to all affected populations. NIH Institutes and Centers, and the scientific community at large, also require a better understanding of the ages of participants and age enrollment gaps of those enrolled in trials and studies, including those sponsored by NIH. Therefore, a workshop will be convened to broaden our understanding of the impact of age-related and other eligibility restrictions on clinical trials and studies, and to identify barriers and facilitators to inclusion of subjects of all ages in research when possible. Input will be solicited at the workshop from investigators with expertise in the conduct of clinical studies with pediatric and older populations, ethics experts and other stakeholders.
Initial plans for a workshop to discuss issues pertaining to inclusion of research subjects of all ages were discussed at NIH’s Inclusion Governance Committee (IGC) in early 2016, after an extensive analysis of clinical trials by the National Institute of Aging. This analysis demonstrated that the age distribution of individuals enrolled in clinical trials for common diseases of older adults was much younger than the age distribution of the diseases in the US population. Another compelling reason for the workshop was the 21st Century Cures Act (Cures Act), P.L. 114-255, which became law on December 13, 2016. The Cures Act requires that a workshop on this issue be held by June 11, 2017, and that any needed inclusion policy updates be made within 180 days of the workshop.