Drug development for major chronic health conditions—aligning with growing public health needs: Proceedings from a multistakeholder think tank

American Heart Journal, Journal Year: 2024, Volume and Issue: 270, P. 23 - 43

Published: Jan. 21, 2024

Language: Английский

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Artificial Intelligence in Cardiovascular Clinical Trials

Journal of the American College of Cardiology, Journal Year: 2024, Volume and Issue: 84(20), P. 2051 - 2062

Published: Nov. 1, 2024

Randomized clinical trials are the gold standard for establishing efficacy and safety of cardiovascular therapies. However, current pivotal expensive, lengthy, insufficiently diverse. Emerging artificial intelligence (AI) technologies can potentially automate streamline trial operations. This review describes opportunities to integrate AI throughout a trial's life cycle, including designing trial, identifying eligible patients, obtaining informed consent, ascertaining physiological event outcomes, interpreting imaging, analyzing or disseminating results. Nevertheless, poses risks, generating inaccurate results, amplifying biases against underrepresented groups, violating patient privacy. Medical journals regulators developing new frameworks evaluate research tools data they generate. Given high-stakes role randomized in medical decision making, must be integrated carefully transparently protect validity

Language: Английский

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Advancing Health Equity in the Cardiovascular Device Life Cycle

Circulation Cardiovascular Quality and Outcomes, Journal Year: 2025, Volume and Issue: unknown

Published: Feb. 3, 2025

Despite advancements in diagnostics and therapeutics for cardiovascular disease, significant health disparities persist among patients from historically marginalized racial ethnic groups, women, individuals who are socioeconomically under-resourced or underinsured, those living rural communities. While transcatheter interventions have revolutionized the treatment landscape cardiology, populations bearing greatest burden of disease continue to face inequitable access poorer outcomes. A notable gap literature concerns role modern approaches device innovation shaping perpetuating disparities. Health equity has been declared one top strategic initiatives 2022 2025 by Food Drug Administration Center Devices Radiological Health, underscoring need greater attention, dialogue, targeted this space. This narrative review uses life cycle as a conceptual framework enhance understanding guide future efforts mitigate field interventional cardiology. Drawing on illustrative examples we examine current practices regulation approval, clinical trial evaluation, adoption patterns, postprocedural outcomes with aim uncovering potential mechanisms identifying opportunities interventions.

Language: Английский

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Association Between Major Adverse Cardiac Events and Hormone Therapy Usage in Prostate Cancer Patients of a Diverse Cohort

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: Oct. 10, 2024

Abstract Importance Hormone therapy (HT) has led to improved overall survival for prostate cancer patients, but may also increase cardiovascular risk. Objective To compare time-to-event major adverse events (MACE) between those with and without HT use in patients. Design, Setting, Participants This retrospective cohort study examined 5,156 participants from the All of Us Research Program who were diagnosed either treated or not (defined as exposure a GnRH agonist, antagonist, and/or anti-androgens). Time MACE was defined using longitudinal electronic health record data. We evaluated whether affected risk Cox regression adjusted established factors. Exposures treatment (HT-treated group), non-HT (control group surgery, radiation treatment, medical therapy), no (active surveillance control group). Main Outcomes Measures Time-to-event MACE, which is interval start (or first diagnosis group) date MACE. did develop right censored at their last healthcare provider visit. Results The final included participants; 851 group, 624 3,681 group. In pre-treatment dyslipidemia, found be associated increased (HR, 1.52; 95% CI, 1.19-1.95; P <.001), while pre-existing association 0.96; 0.71-1.30; = .81). Similar patterns across race ethnicity groups. combined androgen blockade statistically significantly dyslipidemia 1.58; 1.13-2.19; P= .006) observed that prolongation QTc (P= .02). Conclusions Relevance an dyslipidemia. These results suggest stratification can help improve CV outcomes when deciding regimens.

Language: Английский

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Community-Engaged Approaches for Improving the Inclusion of Diverse Communities in a Nutrition Clinical Trial

Nutrients, Journal Year: 2024, Volume and Issue: 16(21), P. 3592 - 3592

Published: Oct. 23, 2024

Cardiometabolic disease (CMD) disproportionately affects African American/Black (AA) and Latino communities. CMD disparities are exacerbated by their underrepresentation in clinical trials for treatments including nutritional interventions. The study aimed to (1) form a precision nutrition community consultant panel (PNCCP) representative of AA communities Los Angeles identify barriers facilitators recruitment retention diverse into (2) develop culturally informed strategies improve trial diversity.

Language: Английский

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