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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Related Experiment Video

Updated: May 27, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Dedicated research navigators: a tool to decrease disparities in clinical trial enrollment?

Teresa K L Boitano1, Jaclyn A Wall1, Lia Bos1

  • 1University of Alabama at Birmingham, Division of Gynecologic Oncology, Birmingham, AL, USA.

International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society
|February 19, 2025
PubMed
Summary

A dedicated research navigator team improved clinical trial enrollment and reduced racial disparities in gynecologic oncology. Key barriers to enrollment included local treatment preference and trial concerns.

Keywords:
CancerClinical TrialsDisparitiesHealth EquitySurvival Outcomes

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Equity

Background:

  • Racial disparities exist in clinical trial enrollment, potentially impacting treatment outcomes.
  • Tertiary academic centers face challenges in ensuring equitable access to clinical trials for diverse patient populations.

Purpose of the Study:

  • To assess the impact of a formalized research team and screening process on racial disparities in clinical trial enrollment.
  • To evaluate the effectiveness of a dedicated research navigator team in a gynecologic oncology setting.

Main Methods:

  • Retrospective cohort study of patients with gynecologic malignancies approached for clinical trial enrollment (March 2018-February 2022).
  • Implementation of a dedicated research navigator team and protocol for patient screening and approach.
  • Comparison of enrollment rates and demographic data between a control group (pre-navigator) and the research navigator team group.

Main Results:

  • The research navigator team increased clinical trial enrollment from 15.0% to 36.9%.
  • Minority inclusion was high, with 27.3% of patients being Black.
  • Patients with recurrent disease were more likely to enroll than those with primary disease (p < .001).
  • Top reasons for declining trials included preference for local treatment (25.0%) and concerns about the trial (21.7%).

Conclusions:

  • A dedicated research navigator team effectively increased eligible patient identification and reduced racial disparities in clinical trial enrollment.
  • Addressing patient preferences for local treatment is crucial for improving trial participation.
  • Continued efforts to identify and overcome barriers are essential for enhancing outcomes in gynecologic oncology clinical trials.