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. 2023 Feb;19(2):e248-e262.
doi: 10.1200/OP.22.00325. Epub 2022 Dec 6.

Cross-Sectional Analysis of Clinical Trial Availability and North Carolina Neighborhood Social Vulnerability

Shakira J Grant  1   2 , Matthew Jansen  3 , Tzy-Mey Kuo  2 , Samuel M Rubinstein  1   2 , Tanya M Wildes  4 , Sascha A Tuchman  1   2 , Hyman B Muss  2   5 , Eben I Lichtman  1   2 , Marjory Charlot  2   5
Affiliations

Cross-Sectional Analysis of Clinical Trial Availability and North Carolina Neighborhood Social Vulnerability

Shakira J Grant et al. JCO Oncol Pract. 2023 Feb.

Abstract

Purpose: Residents of communities facing social vulnerability (eg, poverty) have limited access to clinical trials, leaving them susceptible to experiencing poor health outcomes. We examined the association between North Carolina county-level social vulnerability and available multiple myeloma (MM) trials.

Methods: Using a novel data linkage between ClinicalTrials.gov, the 2019 American Community Survey, and the Centers for Disease Control and Prevention's Social Vulnerability Index, we investigated at the county level (1) availability of MM trial sites and (2) the relationship between Social Vulnerability Index and MM trial site availability using logistic regression.

Results: Between 2002 and 2021, 229 trials were registered across 462 nonunique trial sites in 34 counties. Nearly 50% of trial sites were in academic medical centers, 80% (n = 372) of all trials were industry-sponsored, 60% (n = 274) were early-phase, and 50% (n = 232) were for patients with relapsed or refractory MM. Counties with low as opposed to high poverty rates had six times greater odds of having ≥ 1 MM trial sites (odds ratio [OR], 5.60; 95% CI, 1.85 to 19.64; P = .004). Counties with the lowest percentage of Black Indigenous Persons of Color and non-native English speakers had 77% lower odds (OR, 0.23; 95% CI, 0.07 to 0.69; P = .011) of having ≥ 1 trial sites. The effect remained significant after accounting for the presence of five academic medical centers (n = 95; OR, 0.18; 95% CI, 0.05 to 0.6; P = .008) and adjustment for metropolitan, suburban, or rural status (OR, 0.25; 95% CI, 0.07 to 0.81; P = .025).

Conclusion: Counties with the lowest poverty rates had more MM trial sites, whereas those with the lowest percentage of Black Indigenous Persons of Color populations had fewer MM trial sites. Multilevel efforts are needed to improve the availability and access to trials for socially vulnerable populations.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Matthew Jansen

Other Relationship: American Cancer Society

Samuel M. Rubinstein

Honoraria: Sanofi

Consulting or Advisory Role: Roche, Janssen, EUSA Pharma

Tanya M. Wildes

Honoraria: Carevive Systems

Consulting or Advisory Role: Seattle Genetics, Carevive Systems, Sanofi

Research Funding: Janssen Oncology (Inst)

Sascha A. Tuchman

Honoraria: Shattuck Labs, Janssen

Speakers' Bureau: Celgene

Research Funding: Karyopharm Therapeutics (Inst), Janssen (Inst), Sanofi (Inst), Bristol Myers Squibb/Celgene (Inst), AbbVie (Inst)

Eben I. Lichtman

Consulting or Advisory Role: Lilly (I), ChemoCentryx (I)

Research Funding: Pfizer (I)

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Study flow diagram showing the selection of trials from ClinicalTrials.gov. AL, amyloid light-chain.
FIG 2.
FIG 2.
(A) Dot density map showing myeloma trial sites across North Carolina counties between 2002 and 2021, overall social vulnerability. (B) Availability map showing myeloma trial sites across North Carolina counties 2002-2021, minority status and language theme. (C) Availability map showing myeloma trial sites across North Carolina counties between 2002 and 2021, overall social vulnerability. (D) Context map showing the major cities and urban areas in North Carolina. MM, multiple myeloma; SVI, Social Vulnerability Index.
FIG A1.
FIG A1.
Flowchart of data linkage. We linked registered clinical trial sites from the ClincalTrials.gov database to county-level characteristics from the 2019 American Community Survey and the CDC ASTDR 2018 SVI data set. ASTDR, Agency for Toxic Substances and Disease Registry; CDC, Centers for Disease Control; HUD, US Department of Housing and Urban Development; SVI, Social Vulnerability Index.
See this image and copyright information in PMC

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