The representation of racial and ethnic minority populations in clinical trials continues to be a challenge despite mandates, good intentions, and concerted efforts by funding agencies, regulatory bodies, and researchers to close the clinical trials gap. A lack of diversity in research results in both continued disparities and poorer health outcomes. It is thus imperative that investigators understand and effectively address the challenges of clinical trials participation by underrepresented populations. In this paper, we expound on best practices for participatory research by clearly defining the community, highlighting the importance of proper identification and engagement of strong community partners, and exploring patient- and provider-level barriers and facilitators that require consideration. A clearer understanding of the balance of power between researchers and community partners is needed for any approach that addresses clinical trials representation. Unintended biases in study design and methods may continue to prevent racial and ethnic minority participants from taking part, and significant organizational changes are necessary for efficient and transparent relationships. Comprehensive community engagement in research includes dissemination of clinical trial results within and in partnership with community partners. Through careful deliberation and honest reflection, investigators, institutions, and community partners can develop the tailored blueprints of research collaborations essential for true equity in clinical trials.
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11423934 | PMC |
http://dx.doi.org/10.1016/j.mayocp.2023.07.015 | DOI Listing |
J Crohns Colitis
January 2025
Department of Medicine (Division of Gastroenterology) and Farncombe Family Digestive Health Research Institute; McMaster University, Hamilton ON, Canada.
Introduction: In inflammatory bowel disease (IBD), the number of eosinophils increases in the lamina propria of the intestinal tract, but their specific patho-mechanistic role remains unclear. Elevated blood eosinophil counts in active IBD suggest their potential as biomarkers for predicting response to biologic therapies. This study evaluates blood eosinophil count trends and their predictive value for clinical response and endoscopic improvement in patients with IBD receiving ustekinumab or adalimumab induction therapy.
View Article and Find Full Text PDFJ Med Internet Res
January 2025
Department of Community Health Sciences, Boston University, Boston, MA, United States.
Background: Improving adherence to pre-exposure prophylaxis (PrEP) via digital health interventions (DHIs) for young sexual and gender minority men who have sex with men (YSGMMSM) is promising for reducing the HIV burden. Measuring and achieving effective engagement (sufficient to solicit PrEP adherence) in YSGMMSM is challenging.
Objective: This study is a secondary analysis of the primary efficacy randomized controlled trial (RCT) of Prepared, Protected, Empowered (P3), a digital PrEP adherence intervention that used causal mediation to quantify whether and to what extent intrapersonal behavioral, mental health, and sociodemographic measures were related to effective engagement for PrEP adherence in YSGMMSM.
United European Gastroenterol J
January 2025
Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands.
Acute pancreatitis is a common gastrointestinal disease leading to hospitalisation. Recent advancements in its management have primarily focussed on the development of early phase medical interventions targeting inflammatory pathways, optimisation of supportive treatment (including fluid resuscitation, pain management and nutritional management), appropriate use of antibiotics, implementation of minimally invasive interventions for infected necrosis, and the necessity of follow-up for long-term complications. These advancements have significantly improved personalised management and overall outcomes of acute pancreatitis.
View Article and Find Full Text PDFJAMA Netw Open
January 2025
Latin American Cooperative Oncology Group (LACOG), Porto Alegre, Brazil.
Importance: The open-label randomized phase 2 LACOG0415 trial evaluated 3 treatment strategies for patients with advanced castration-sensitive prostate cancer (CSPC): androgen deprivation therapy (ADT) plus abiraterone acetate and prednisone (AAP), apalutamide (APA) alone, or APA plus AAP.
Objective: To investigate the association of ADT plus AAP, APA alone, or APA plus AAP with health-related quality of life (HRQOL) in patients with advanced CSPC in the LACOG0415 trial.
Design, Setting, And Participants: The LACOG0415 randomized clinical trial comprised 128 patients with advanced CSPC who were randomized (1:1:1) to 1 of 3 treatment arms from October 16, 2017, to April 23, 2019.
JAMA Intern Med
January 2025
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Importance: The optimal antiviral drug for treatment of nonsevere influenza remains unclear.
Objective: To compare effects of antiviral drugs for treating nonsevere influenza.
Data Sources: MEDLINE, Embase, CENTRAL, CINAHL, Global Health, Epistemonikos, and ClinicalTrials.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!