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Published on: January 12, 2018
Improving clinical trial enrollment in minority racial and ethnic patients with gynecologic malignancy
Olivia D Lara1, Kathryn Allen2, Amin Yakubov2
1Division of Gynecologic Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Purpose:
Racial and ethnic minorities remain underrepresented in clinical trials . Underrepresentation of racial groups leads to the selection of therapeutic interventions that may not be representative of the population expected to use the medicine. This study evaluates the effectiveness of a set of implementation strategies to increase underrepresented patients in gynecologic cancer clinical trials.
Methods:
An interrupted time series analysis evaluating implementation strategies (pre-screening and fast-track referral) was conducted from January 2021 to May 2022. Descriptive analysis of gynecologic oncology patient screening and accrual was compared before and after intervention implementation.
Results:
During the study period (pre- and post-intervention), 26 patients were screened, and 9 patients enrolled in therapeutic gynecologic cancer clinical trials. Prior to the intervention, 7 patients were screened and 2 patients enrolled onto a clinical trial. Following the intervention, 19 patients were screened and 7 patients enrolled in a cancer clinical trial. Black patients comprised 13 of 19 (68.4%) of patients post-intervention compared to 1 of 7 (14.3 %) of patients screened pre-intervention (p < 0.05). All 7 patients enrolled post intervention were racial and ethnic minorities (non-Hispanic Black [4 of 7] and Hispanic White [3 of 7]) compared to no minority patients enrolled pre-intervention (p < 0.05). Screening increased 2.5-fold for all patients, and 5- fold for minority patients. Clinical trial enrollment increased 3.5-fold following intervention.
Conclusions:
A combination of pre-screening and fast-track referral intervention in a racial and ethnically diverse urban academic hospital was associated with a significant increase in minority screening and enrollment. Structured strategies to overcome barriers to underrepresented racial and ethnic patient accrual in academic hospitals are urgently warranted.
Insights
Implementing pre-screening and fast-track referrals significantly increased minority participation in gynecologic cancer clinical trials. These strategies are crucial for improving diversity in cancer research.
Area of Science:
- Oncology
- Clinical Trials
- Health Equity
Background:
- Racial and ethnic minorities are underrepresented in clinical trials.
- This disparity can lead to therapeutic interventions not being representative of the general population.
- Ensuring diverse trial participation is critical for equitable healthcare outcomes.
Purpose of the Study:
- To evaluate the effectiveness of implementation strategies in increasing the enrollment of underrepresented patients in gynecologic cancer clinical trials.
- To assess the impact of pre-screening and fast-track referral on minority participation.
Main Methods:
- An interrupted time series analysis was conducted from January 2021 to May 2022.
- Implementation strategies included pre-screening and fast-track referral.
- Descriptive analysis compared patient screening and accrual rates before and after the intervention.
Main Results:
- Clinical trial screening increased 2.5-fold overall and 5-fold for minority patients.
- Enrollment in gynecologic cancer clinical trials increased 3.5-fold post-intervention.
- Minority enrollment increased significantly, with all 7 post-intervention enrollees being from underrepresented racial and ethnic groups.
Conclusions:
- A combination of pre-screening and fast-track referral significantly improved minority screening and enrollment in gynecologic cancer clinical trials.
- Structured strategies are urgently needed to overcome barriers to patient accrual in academic hospitals.
- These findings highlight the importance of targeted interventions for enhancing diversity in clinical research.
