Disparities in the Inclusion of Racial and Ethnic Minority Groups and Older Adults in Prostate Cancer Clinical Trials: A Meta-analysis.

Importance: Prostate cancer (PCa) is marked by disparities in clinical outcomes by race, ethnicity, and age. Equitable enrollment in clinical trials is fundamental to promoting health equity. Objective: To evaluate disparities in the inclusion of racial and ethnic minority groups and older adults across PCa clinical trials. Data Sources: MEDLINE, Embase, and ClinicalTrials.gov were searched to identify primary trial reports from each database's inception through February 2021. Global incidence in age subgroups and US population-based incidence in racial and ethnic subgroups were acquired from the Global Burden of Disease and Surveillance, Epidemiology, and End Results 21 incidence databases respectively. Study Selection: All phase 2/3 randomized PCa clinical trials were eligible for age disparity analyses. Trials recruiting exclusively from the US were eligible for primary racial and ethnic disparity analyses. Data Extraction and Synthesis: This study was reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines. Data were pooled using a random-effects model. Main Outcomes and Measures: Enrollment incidence ratios (EIRs), trial proportions (TPs) of participants 65 years or older or members of a racial and ethnic subgroup divided by global incidence in the corresponding age group, or US population-based incidence in the corresponding racial and ethnic subgroup, were calculated. Meta-regression was used to explore associations between trial characteristics and EIRs and trends in EIRs during the past 3 decades. Results: Of 9552 participants among trials reporting race, 954 (10.8%) were African American/Black, 80 (1.5%) were Asian/Pacific Islander, and 8518 (78.5) were White. Of 65 US trials, 45 (69.2%) reported race and only 9 (13.8%) reported data on all 5 US racial categories. Of 286 global trials, 75 (26.2%) reported the enrollment proportion of older adults. Outcomes by race and age were reported in 2 (3.1%) and 41 (15.0%) trials, respectively. Black (EIR, 0.70; 95% CI, 0.59-0.83) and Hispanic (EIR, 0.70; 95% CI, 0.59-0.83) patients were significantly underrepresented in US trials. There was no disparity in older adult representation (TP, 21 143 [71.1%]; EIR, 1.00; 95% CI, 0.95-1.05). The representation of Black patients was lower in larger trials (meta-regression coefficient, -0.06; 95% CI, -0.10 to -0.02; P = .002). Conclusions and Relevance: The results of this meta-analysis suggest that Black and Hispanic men are underrepresented in trials compared with their share of PCa incidence. The representation of Black patients has consistently remained low during the past 2 decades.

Physiological biomarkers of chronic stress: A systematic review.

OBJECTIVE: The basic objective of this systematic review was to identify potential biomarkers for chronic stress. METHODS: A systematic review of studies linking biomarkers in people with chronic stress was conducted using PRISMA guidelines. The last 40 years' studies were included in the systematic review with no age restrictions; animal studies were excluded from the study. Electronic databases including PubMed, Embase, and Google Scholar were searched for the study purpose. The studies were searched using the combinations of search terms that comprised chronic stress together with the keywords hypothalamic-pituitary-adrenal axis (HPA axis), autonomic nervous system (ANS), immune system, metabolic biomarkers, cortisol, hair cortisol, salivary cortisol, urinary cortisol, epinephrine, norepinephrine, adrenocorticotropic hormone (ACTH), brain-derived neurotropic factor (BDNF), metabolic biomarkers, antioxidants, glucose, hemoglobin, C-reactive protein (CRP), cytokines, pro-inflammatory cytokines, anti-inflammatory cytokines, and tumor necrosis factor (TNF). RESULTS: A total of 37 studies out of 671 studies met the eligibility criteria and were included in this review. Potential diagnostic biomarkers of chronic stress included cortisol, ACTH, BDNF, catecholamines, glucose, HbA1c, triglycerides, cholesterol, prolactin, oxytocin, dehydroepiandrosterone sulfate (DHEA-S), CRP, and interleukin - 6 and 8. While the others including antioxidants and natural killer (NK) cells require further validation. Taken together, addition, these stress biomarkers have critical prognostic capacities for stress-associated diseases and therapeutic guidance. CONCLUSION: This systematic review provides an update to the literature by highlighting the role of physiological biomarkers in chronic stress and describing their prognostic and therapeutic values.