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Updated: Feb 1, 2026

In Silico Clinical Trials for Cardiovascular Disease
Published on: May 27, 2022
Increasing Diversity in Clinical Trials: Overcoming Critical Barriers
Abstract:
Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients' willingness to participate in trials and-based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators-formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.
Insights
Racial and ethnic minorities face barriers to clinical trial participation. This study identified solutions and developed a communication strategy to improve diversity in clinical trials.
Area of Science:
- Clinical trial research
- Health equity
- Participant diversity
Background:
- Clinical trial data are essential for drug safety and efficacy evaluation.
- Population subgroups may exhibit differential responses to treatments based on various factors.
- Underrepresentation of racial and ethnic minorities in clinical trials persists, hindering generalizability of findings.
Purpose of the Study:
- To investigate barriers affecting minority patient participation in clinical trials.
- To develop and test potential solutions for enhancing trial diversity through stakeholder input.
Main Methods:
- Literature review and evaluation of existing data.
- Input gathered from diverse stakeholders: minority patients, referring physicians, minority-serving physicians, and trial coordinators.
- Application of the transtheoretical model of behavior change to identify resonant solutions.
- Development of a communications message map for a multistakeholder approach.
Main Results:
- Identified key themes and barriers impacting minority patient willingness to participate.
- Validated potential solutions across different stakeholder groups.
- Developed a communication strategy to address identified barriers.
Conclusions:
- Addressing underrepresentation requires understanding patient and provider perspectives.
- A multistakeholder communication approach is crucial for overcoming participation barriers.
- Improving clinical trial diversity is essential for equitable healthcare outcomes.
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