دورية أكاديمية
Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations.
| العنوان: | Clinical Trial Inclusion and Impact on Early Adoption of Medical Innovation in Diverse Populations. |
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| المؤلفون: | Adamson PB; Heart Failure Division, Abbott Laboratories, Austin, Texas, USA. Electronic address: philip.adamson@abbott.com., Echols M; Division of Cardiology, Morehouse School of Medicine, Atlanta, Georgia, USA., DeFilippis EM; Division of Cardiology, Columbia University Irving Medical Center, New York, New York, USA., Morris AA; Emory School of Medicine, Atlanta, Georgia, USA., Bennett M; Allina Health Minneapolis Heart Institute, Minneapolis, Minnesota, USA., Abraham WT; Ohio State University Wexner Medical Center, Columbus, Ohio, USA., Lindenfeld J; Vanderbilt University Medical Center, Nashville, Tennessee, USA., Teerlink JR; Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, San Francisco, California, USA., O'Connor CM; Inova Heart and Vascular Institute, Falls Church, Virginia, USA; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA., Connolly AT; Global Data Science and Analytics, Abbott Laboratories, Santa Clara, California, USA., Li H; Global Data Science and Analytics, Abbott Laboratories, Santa Clara, California, USA., Fiuzat M; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA., Vaduganathan M; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA., Vardeny O; Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota, USA., Batchelor W; Inova Heart and Vascular Institute, Falls Church, Virginia, USA., McCants KC; Norton Heart & Vascular Institute, Norton Healthcare, Louisville, Kentucky, USA. |
| مؤلفون مشاركون: | Heart Failure Collaboratory |
| المصدر: | JACC. Heart failure [JACC Heart Fail] 2024 Jul; Vol. 12 (7), pp. 1212-1222. Date of Electronic Publication: 2024 Mar 25. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101598241 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-1787 (Electronic) Linking ISSN: 22131779 NLM ISO Abbreviation: JACC Heart Fail Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, NY : Elsevier, [2013]- |
| مواضيع طبية MeSH: | Heart Failure*/therapy , Medicare* , Clinical Trials as Topic*, Humans ; Male ; Female ; Aged ; United States ; Middle Aged ; Patient Selection ; Aged, 80 and over ; Hospitalization/statistics & numerical data |
| مستخلص: | Background: Inadequate inclusion in clinical trial enrollment may contribute to health inequities by evaluating interventions in cohorts that do not fully represent target populations. Objectives: The aim of this study was to determine if characteristics of patients with heart failure (HF) enrolled in a pivotal trial are associated with who receives an intervention after approval. Methods: Demographics from 2,017,107 Medicare patients hospitalized for HF were compared with those of the first 10,631 Medicare beneficiaries who received implantable pulmonary artery pressure sensors. Characteristics of the population studied in the pivotal CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) clinical trial (n = 550) were compared with those of both groups. All demographic data were analyzed nationally and in 4 U.S. regions. Results: The Medicare HF cohort included 80.9% White, 13.3% African American, 1.9% Hispanic, 1.3% Asian, and 51.5% female patients. Medicare patients <65 years of age were more likely to be African American (33%) and male (58%), whereas older patients were mostly White (84%) and female (53%). Forty-one percent of U.S. HF hospitalizations occurred in the South; demographic characteristics varied significantly across all U.S. regions. The CHAMPION trial adequately represented African Americans (23% overall, 35% <65 years of age), Hispanic Americans (2%), and Asian Americans (1%) but underrepresented women (27%). The trial's population characteristics were similar to those of the first patients who received pulmonary artery sensors (82% White, 13% African American, 1% Asian, 1% Hispanic, and 29% female). Conclusions: Demographics of Centers for Medicare and Medicaid Services beneficiaries hospitalized with HF vary regionally and by age, which should be considered when defining "adequate" representation in clinical studies. Enrollment diversity in clinical trials may affect who receives early application of recently approved innovations. Competing Interests: Funding Support and Author Disclosures Abbott provided resources for access and analyses of CMS claims data and demographic information from the CHAMPION trial. Dr Adamson is an employee of Abbott. Dr Echols is a consultant to Abbott. Dr DeFilippis serves on a clinical trial committee for Abiomed. Dr Morris has received research funding from the Agency for Healthcare Research and Quality (HS026081), the American Heart Association, Google, and Merck; and has received consulting fees from Abbott, Acorai, Boehringer Ingelheim, Eli Lilly, Cytokinetics, Edwards Lifesciences, Ionis, Merck, and Regeneron. Dr Bennett has received consulting fees and speaker honoraria from Abbott. Dr Abraham has received consulting fees from Abbott Vascular, AquaPass, Boehringer Ingelheim, Impulse Dynamics, Sensible Medical Innovations, V-Wave, and Zoll Respicardia. Dr Lindenfeld has received consulting and/or research support from Abbott, AstraZeneca, Boehringer Ingelheim, Boston Scientific, CVRx, Edwards Lifesciences, Impulse Dynamics, Merck, Medtronic, V-Wave, Vifor, and Volumetrix. Dr Teerlink has received research support from 3ive Labs, AstraZeneca, Bayer, Boehringer Ingelheim, Cardurion, Cytokinetics, EBR Systems, Edwards Lifesciences, Impulse Dynamics, Kaiser Permanente, LivaNova, Medtronic, Myovant Sciences, the Patient-Centered Outcomes Research Institute, RECARDIO, and V-Wave; and is a consultant for 3ive Labs, Arena, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardurion, CorHepta, Cytokinetics, Daiichi-Sankyo, EBR Systems, Edwards Lifesciences, Eli Lilly Impulse Dynamics, JuvLabs, Kaiser Permanente, LivaNova, Medtronic, Myovant Sciences, Novartis, the Patient-Centered Outcomes Research Institute, Pfizer, ReCor Medical, Regeneron, Reprieve, Tectonic, V-Wave, Verily, ViCardia, and Windtree Therapeutics. Dr O’Connor has received research funding from Merck; and has received consulting fees from Bayer and Dey. Dr Connolly is an employee of Abbott. Dr Li is an employee of Abbott. Dr. Vaduganathan has received research grant support from, served on advisory boards for, or has had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer, Baxter Healthcare, Boehringer Ingelheim, Bristol Myers Squibb, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Merck, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health; and has participated on clinical trial committees for studies sponsored by AstraZeneca, Galmed, Novartis, Bayer, Occlutech, and Impulse Dynamics. Dr Batchelor has received consulting fees from Boston Scientific, Medtronic, Edwards Lifesciences, V-Wave, Chiesi, Abbott, and Idorsia; and has received research support from Abbott and Boston Scientific. Dr McCants has received consulting fees and speaker honoraria from Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: clinical trial methods; diversity and inclusion; heart failure; hospitalizations; innovation; quality |
| تواريخ الأحداث: | Date Created: 20240326 Date Completed: 20240703 Latest Revision: 20240703 |
| رمز التحديث: | 20240704 |
| DOI: | 10.1016/j.jchf.2024.02.015 |
| PMID: | 38530702 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 2213-1787 |
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| DOI: | 10.1016/j.jchf.2024.02.015 |