Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments' generalizability, efficacy, and safety. Eliminating Disparities in Clinical Trials, a national initiative comprising a stakeholder network of researchers, community advocates, policymakers, and federal representatives, undertook a critical analysis of older adults' structural barriers to clinical trial participation. We present practice and policy change recommendations emerging from this process and their rationale, which spanned multiple themes: (1) decision making with cognitively impaired patients; (2) pharmacokinetic differences and physiological age; (3) health literacy, communication, and aging; (4) geriatric training; (5) federal monitoring and accountability; (6) clinical trial costs; and (7) cumulative effects of aging and ethnicity.
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http://dx.doi.org/10.2105/AJPH.2009.162982 | DOI Listing |
Artif Organs
January 2025
International Renal Research Institute of Vicenza (IRRIV), Vicenza, Veneto, Italy.
Background: Contrast-associated acute kidney injury (CA-AKI) is frequent in patients with chronic kidney disease who are submitted to cardiac endovascular procedures using iodinated contrast. In hemoadsorption, cartridges containing styrene-divinylbenzene sorbent resin are applied to remove substances from the blood through an extracorporeal circuit. Importantly, iodinated contrast is also removed via adsorption.
View Article and Find Full Text PDFJAMA Netw Open
January 2025
Interdisciplinary Orthopaedics, Department of Orthopaedic Surgery, Aalborg University Hospital, Aalborg, Denmark.
Importance: Two meta-analyses published in 2012 found breech presentation, family history of developmental dysplasia of the hip (DDH), female sex, and primiparity to increase the risk of DDH. However, the DDH definition, reference tests, and the age of the examined children varied considerably, complicating the translation of those findings to current screening guidelines.
Objective: To evaluate the association of previously proposed risk factors with the risk of sonography-verified DDH.
Stat Med
February 2025
MRC Clinical Trials Unit at UCL, University College London, London, UK.
Introduction: In clinical trials, a treatment policy strategy is often used to handle treatment nonadherence. However, estimation in this context is complicated when data are missing after treatment deviation. Reference-based multiple imputation has been developed for the analysis of a longitudinal continuous outcome in this setting.
View Article and Find Full Text PDFStat Med
February 2025
Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY.
Clinical trials are often designed based on limited information about effect sizes and precision parameters with risks of underpowered studies. This is more problematic for SMARTs where strategy effects are based on sequences of treatments. Sample size adjustment offers flexibility through re-estimating sample size during the trial to ensure adequate power at the final analysis.
View Article and Find Full Text PDFStat Med
February 2025
MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.
There is a growing number of Phase I dose-finding studies that use a model-based approach, such as the CRM or the EWOC method to estimate the dose-toxicity relationship. It is common to assume that all patients will have similar toxicity risk given the dose regardless of patients' individual characteristics. In many trials, however, some patients' covariates (e.
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