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This study aimed to evaluate the diversity of clinical trials informing assessments conducted by the Institute for Clinical and Economic Review. This was a cross-sectional study of pivotal trials included in completed Institute for Clinical and Economic Review assessments over 5 years (2017-2021). Representation of racial/ethnic minority groups, females, and older adults was compared with the disease-specific and US population, using a relative representation cutoff of 0.8 for adequate representation. A total of 208 trials, evaluating 112 interventions for 31 unique conditions, were examined. Race/ethnicity data were inconsistently reported. The median participant-to-disease representative ratio (PDRR) for Blacks/African Americans (0.43 [interquartile range (IQR) 0.24-0.75]), American Indians/Alaska Natives (0.37 [IQR 0.09-0.77]), and Hispanics/Latinos (0.79 [IQR 0.30-1.22]) were below the adequate representation cutoff. In contrast, Whites (1.06 [IQR 0.92-1.2]), Asians (1.71 [IQR 0.50-3.75]), and Native Hawaiian/Other Pacific Islanders (1.61 [IQR 0.77-2.81]) were adequately represented. Findings were similar when compared with the US Census, except for Native Hawaiian/Pacific Islanders, which was substantially worse. Relative to all trials, a higher proportion of US-based trials adequately represented Blacks/African Americans (61% vs 23%, P <.0001) and Hispanics/Latinos (68% vs 50%; P =.047), but a lower proportion adequately represented Asians (15% vs 67%, P <.0001). Females were adequately represented in 74% of trials (PDRR: 1.02 [IQR 0.79-1.14]). Nevertheless, older adults were adequately represented in only 20% of trials (PDRR: 0.30 [IQR 0.13-0.64]). The representation of racial/ethnic minorities and older adults was inadequate. Efforts are needed to enhance the diversity of clinical trials. Standardized and transparent evaluation of trial diversity should be part of the health technology assessment process. • Lack of diversity in clinical trial populations, particularly in pivotal trials that serve as the key source of evidence for regulatory, clinical, and policy decisions, has implications for generalizability and fairness. • Based on the US Census and disease-specific prevalence estimates, this study showed that racial/ethnic minorities and older adults were underrepresented in the majority of the trials that serve as the major source of evidence for health technology assessment in the United States and further highlighted the disparity in the racial diversity of US-based trials versus global trials. • Given the changing US population and the current trend of global trials, clinical trial diversity may worsen if proactive steps are not taken to mitigate this. Although investigators and clinical trial developers are at the front line of recruiting diverse participants, regulators and health technology assessment bodies have a role in enhancing transparency and accountability by developing standardized approaches to evaluating clinical trial diversity. [ABSTRACT FROM AUTHOR]