Original Research
Sunday, October 13, 2024
12:45 PM–02:15 PM
Abstract
Introduction:
Guideline-changing trials support clinical decision-making worldwide. Focus on high disease prevalence regions for recruitment of clinical trial participants is common in an attempt to enroll an adequate number of individuals. With regards to clinical trials for cholesterol management, the relationship between geographic distribution of clinical trial sites and cardiovascular (CV) mortality rate is unknown.
Research Question or Hypothesis:
Is there a correlation between the global geographic distribution of clinical trials and CV mortality rate?
Study Design:
This is an observational, cross-sectional study that involves analyzing data from published clinical trials and their geographic location.
Methods:
Guideline-Influencing CV clinical trials were identified using The American College of Cardiology/American Heart Association Guideline on the Management of Blood Cholesterol. The locations of registered randomized controlled trials from ClinicalTrials.gov were matched with regional data from Global Burden of Cardiovascular Disease and Risks 1990-2022. The correlation between the number of sites and CV mortality reduction rates were tested utilizing the Spearman’s test.
Results:
A total of 659 trial sites from 71 clinical trials were identified and categorized into 21 geographic regions worldwide. Regions with 10 or more sites had a median CV mortality reduction of 47% from 1990-2022, while those with fewer than 10 sites had a median CV mortality reduction of 18.4%. High-Income North America and Western Europe had the highest number of trial sites (n=291, 123, respectively) and CV mortality rate reduction of 60% and 46%, respectively. A positive correlation (rs: 0.56332) was identified between CV mortality reduction from 1990-2022 and the number of regional trial sites.
Conclusion:
Regions with higher numbers of clinical trial sites had greater reductions in CV mortality from 1990-2022. Current research must prioritize and enhance patient representation from geographic areas where CV mortality rates remain high in order to overcome health disparities and improve health outcomes worldwide.
Presenting Author
Michelle Lam PharmD CandidateNortheastern University
Authors
Marwah Alnewais PharmD, BCACP
Boston Medical Center
Natalie Imamura PharmD Candidate
Northeastern University
Erin Weeda PharmD, BCPS
University of South Carolina