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Expanding access to early phase trials: the CATCH-UP.2020 experience
Joaquina C Baranda1, Francisco J Diaz2, Larry Rubinstein3
1Department of Medical Oncology, University of Kansas Cancer Center, Kansas City, KS, USA.
Background:
Disparities in cancer outcomes persist for underserved populations; one important aspect of this is limited access to promising early phase clinical trials. To address this, the National Cancer Institute-funded Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) was created. We report the tools developed and accrual metrics of the initial year of CATCH-UP.2020 with a focus on racial, ethnic, geographic, and socioeconomically underserved populations.
Methods:
CATCH-UP.2020 is a P30 supplement awarded to 8 National Cancer Institute-designated cancer centers with existing resources to rapidly open and accrue to Experimental Therapeutics Clinical Trials Network (ETCTN) trials with emphasis on engaging patients from underserved populations. Sites used patient-based, community-based, investigator-based, and program-based tools to meet specific program goals.
Results:
From September 2020 to August 2021, CATCH-UP.2020 sites opened 45 ETCTN trials. Weighted average trial activation time for the 7 sites reporting this was 107 days. In the initial year, sites enrolled 145 patients in CATCH-UP.2020 with 68 (46.9%) representing racial, ethnic, rural, and socioeconomically underserved populations using the broader definition of underserved encompassed in the grant charge. During the initial year of CATCH-UP.2020, a time impacted by the COVID-19 pandemic, 15.8% (66 of 417) and 21.4% (31 of 145) of patients enrolled to ETCTN trials at network and at CATCH-UP sites, respectively, were from racial and ethnic minority groups, a more limited definition of underserved for which comparable data are available.
Conclusion:
Targeted funding accelerated activation and accrual of early phase trials and expanded access to this therapeutic option for underserved populations.
Insights
The Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) initiative successfully accelerated early phase clinical trial activation and patient accrual. This program expanded access to novel cancer therapies for underserved populations, addressing critical disparities in cancer outcomes.
Area of Science:
- Clinical trial management
- Cancer therapeutics
- Health equity
Background:
- Persistent disparities in cancer outcomes disproportionately affect underserved populations.
- Limited access to early-phase clinical trials is a significant barrier for these groups.
- The National Cancer Institute-funded Create Access to Targeted Cancer Therapy for Underserved Populations (CATCH-UP.2020) program was established to address these issues.
Purpose of the Study:
- To report on the tools developed and accrual metrics from the initial year of the CATCH-UP.2020 program.
- To focus on the engagement and enrollment of racial, ethnic, geographic, and socioeconomically underserved populations.
- To evaluate the program's effectiveness in improving access to targeted cancer therapies.
Main Methods:
- CATCH-UP.2020 is a supplement to P30 grants awarded to 8 National Cancer Institute-designated cancer centers.
- Sites utilized a combination of patient-based, community-based, investigator-based, and program-based tools.
- Emphasis was placed on rapidly opening and accruing patients to Experimental Therapeutics Clinical Trials Network (ETCTN) trials.
Main Results:
- During the initial year (September 2020-August 2021), 45 ETCTN trials were opened by CATCH-UP.2020 sites.
- The weighted average trial activation time was 107 days.
- 145 patients were enrolled, with 68 (46.9%) from underserved populations (racial, ethnic, rural, socioeconomic).
- Patients from racial and ethnic minority groups represented 15.8% of ETCTN network accruals and 21.4% of CATCH-UP site accruals.
Conclusions:
- Targeted funding accelerated the activation and accrual of early-phase clinical trials.
- The CATCH-UP.2020 program successfully expanded access to therapeutic options for underserved populations.
- The initiative demonstrated a positive impact on cancer care equity.
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