{"doi":"10.1111/jgs.18831","title":"<scp>National Institute on Aging</scp> efforts toward ensuring representation of diverse older adults in clinical studies","abstract":"Supporting healthy aging and treating health concerns among adults aged 65 and older requires the development of new interventions validated through clinical trials and translated effectively to the clinic. To achieve this goal, clinical studies and clinical trials must be designed using robust methods that maximize the inclusion of older adults. Unfortunately, clinical trials in the United States have often excluded many older adults,1, 2 particularly those with significant comorbidities and individuals aged 80 and older (the so-called “oldest old”). Also often underrepresented in clinical research are members of the National Institute on Aging (NIA) Health Disparities Research Framework3 priority populations, which are consistent with the recently updated NIH-designated disparity populations (rural, socioeconomically disadvantaged, sex and gender minority, disability, American Indian/Native American, Asian American, Black/African American, Latino/Hispanic, Native Hawaiian, and Other Pacific Islanders). Thus, the outcomes of many clinical studies and trials—including those supported by NIH4—are not generalizable to individuals who would potentially benefit from the interventions being tested.5 In addition to compromising the generalizability of results, a lack of appropriate representation in clinical studies compounds health disparities, hinders innovation, and may result in increased healthcare costs.6 Funding research that is not adequately inclusive both perpetuates the paucity of accurate clinical data available to inform treatment decisions for many older adults and contradicts the mission of the NIA. Exclusion of older adults in clinical studies occurs even though they are often the population at highest risk for the disease or condition under study and might most benefit from the intervention (see Table 1).4 To facilitate interpretation of study findings and reduce potential risks to participants, trials often exclude persons with comorbidities or taking certain medications—criteria that can disproportionately affect older adults. Many trials also limit trial inclusion to those adults younger than 75 years of age.4 Even in studies for which inclusion criteria are less stringent, primary care physicians may be reluctant to recommend participation in a clinical trial, regardless of patient eligibility.13 Recruitment of older participants to interventional trials addressing Alzheimer's disease and related forms of dementia (AD/ADRD) may be particularly challenging given the cognitive challenges and increased need for a study partner.14 Reaching and retaining populations that have been traditionally excluded from and underrepresented in research requires proactive planning and implementation of tailored, culturally-appropriate strategies,15 including, in many cases, explicit efforts to gain the trust of the community identified for recruitment.16 Furthermore, specific barriers to participation may differ among ethnic and racial groups.9, 17 In 2015, NIA developed its Health Disparities Research Framework, which identifies nine priority populations and guides researchers to consider four key domains and various levels of analysis in aging research using a life course perspective.3 Subsequently, in 2016, Congress passed the 21st Century Cures Act, which—among other things—required the NIH to examine and address gaps in policies around inclusion and reporting of clinical trial results by age.18 Both the Framework and the Cures Act informed NIA's critical role in the development of two seminal workshops on Inclusion Across the Lifespan (June 2017, September 2020).19, 20 Building upon these activities, in 2019 NIH adopted a new policy requiring clinical trials to include a plan for enrolling individuals across the lifespan and justify any exclusions. Specifically, the requirements include submission of a planned enrollment table outlining sex, race, and ethnicity of participants, and a written scientific justification for any ","journal":"Journal of the American Geriatrics Society","year":2024,"id":476432,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9496,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":480502,"name":"Patricia L. Jones","orcid":"0000-0001-7147-7699","position":1,"is_corresponding":false},{"id":849071,"name":"Holly A. Massett","orcid":null,"position":2,"is_corresponding":false},{"id":396959,"name":"Amy S. Kelley","orcid":"0000-0002-6345-9834","position":3,"is_corresponding":false},{"id":437230,"name":"Catherine Nagy","orcid":null,"position":0,"is_corresponding":true}],"reference_count":16,"raw_metadata":null,"created_at":"2026-07-19T02:06:25.428435Z","pmid":"38445863","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}