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. 2022 May;18(5):e780-e785.
doi: 10.1200/OP.22.00037.

Implementation Strategies to Increase Clinical Trial Enrollment in a Community-Academic Partnership and Impact on Hispanic Representation: An Interrupted Time Series Analysis

Nahomy Ledesma Vicioso  1 , Diana Lin  1 , Daniel R Gomez  1 , Jonathan T Yang  1 , Nancy Y Lee  1 , Andreas Rimner  1 , Yoshiya Yamada  1 , Michael J Zelefsky  1 , Noah S Kalman  2 , Charles E Rutter  3 , Rupesh R Kotecha  2 , Minesh P Mehta  2 , Joseph E Panoff  2 , Michael D Chuong  2 , Andrew L Salner  3 , Jamie S Ostroff  4 , Lisa C Diamond  5 , Noah J Mathis  1 , Oren Cahlon  1 , David G Pfister  6 , Zhigang Zhang  7 , Fumiko Chino  1 , Jillian Tsai  1 , Erin F Gillespie  1
Affiliations

Implementation Strategies to Increase Clinical Trial Enrollment in a Community-Academic Partnership and Impact on Hispanic Representation: An Interrupted Time Series Analysis

Nahomy Ledesma Vicioso et al. JCO Oncol Pract. 2022 May.

Abstract

Purpose: Community-academic partnerships have the potential to improve access to clinical trials for under-represented minority patients who more often receive cancer treatment in community settings. In 2017, the Memorial Sloan Kettering (MSK) Cancer Center began opening investigator-initiated clinical trials in radiation oncology in targeted community-based partner sites with a high potential to improve diverse population accrual. This study evaluates the effectiveness of a set of implementation strategies for increasing overall community-based enrollment and the resulting proportional enrollment of Hispanic patients on trials on the basis of availability in community-based partner sites.

Methods: An interrupted time series analysis evaluating implementation strategies was conducted from April 2018 to September 2021. Descriptive analysis ofHispanic enrollment on investigator-initiated randomized therapeutic radiation trials open at community-based sites was compared with those open only at themain academic center.

Results: Overall, 84 patients were enrolled in clinical trials in the MSK Alliance, of which 48 (56%) identified as Hispanic. The quarterly patient enrollment pre- vs postimplementation increased from 1.39 (95% CI, -3.67 to 6.46) to 9.42 (95% CI, 2.05 to 16.78; P5 .017). In the investigator-initiated randomized therapeutic radiation trials open in the MSK Alliance, Hispanic representation was 11.5% and 35.9% in twometastatic trials and 14.2% in a proton versus photon trial. Inmatched trials open only at the main academic center, Hispanic representation was 5.6%, 6.0%, and 4.0%, respectively.

Conclusion: A combination of practice-level and physician-level strategies implemented at community-based partner sites was associated with increased clinical trial enrollment, which translated to improved Hispanic representation. This supports the role Q:2 of strategic community-academic partnerships in addressing disparities in clinical trial enrollment.

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Conflict of interest statement

Daniel R. GomezHonoraria: Varian Medical Systems, Merck, Bristol Myers Squibb, AstraZeneca, RefleXion Medical, Vindico Medical Education, US Oncology, GRAILConsulting or Advisory Role: Olympus Medical Systems, Medtronic, Johnson & Johnson/JanssenResearch Funding: Merck, Varian Medical Systems, AstraZeneca, Bristol Myers SquibbTravel, Accommodations, Expenses: Varian Medical Systems, AstraZeneca, Merck, Vindico Medical Education, US Oncology, Driver Inc Jonathan T. YangStock and Other Ownership Interests: Nanocan TherapeuticsConsulting or Advisory Role: Debiopharm Group, Galera Therapeutics, AstraZeneca, Nanocan TherapeuticsResearch Funding: AstraZeneca, Kazia Therapeutics, X-RAD Therapeutics Nancy Y. LeeConsulting or Advisory Role: Merck, Pfizer, Merck Serono, Sanofi, Mirati Therapeutics, Roche/GenentechResearch Funding: AstraZeneca, Pfizer (Inst) Andreas RimnerHonoraria: More HealthConsulting or Advisory Role: AstraZeneca, Merck, Boehringer IngelheimResearch Funding: Varian Medical Systems (Inst), Boehringer Ingelheim (Inst), Pfizer (Inst), AstraZeneca (Inst), Merck (Inst) Yoshiya YamadaEmployment: Memorial Sloan-Kettering Cancer CenterLeadership: Chordoma FoundationHonoraria: Varian Medical Systems, BrainLAB, Vision RTSpeakers' Bureau: BrainLAB, Vision RT, Varian Medical SystemsResearch Funding: Varian Medical SystemsTravel, Accommodations, Expenses: Philips HealthcareOther Relationship: University of Wollongong Michael J. ZelefskyHonoraria: AccurayConsulting or Advisory Role: Alpha Tau, Boston ScientificPatents, Royalties, Other Intellectual Property: Ferring provided partial funding for a clinical trial (Inst)Other Relationship: Editor in Chief for Brachytherapy Noah S. KalmanConsulting or Advisory Role: Naveris Rupesh R. KotechaHonoraria: Accuray, Novocure, Elekta, BrainLAB, Elsevier, ViewRay, PeerViewConsulting or Advisory Role: ViewRay, NovocureSpeakers' Bureau: NovocureResearch Funding: Medtronic (Inst), Blue Earth Diagnostics (Inst), Novocure (Inst), GT Medical Technologies (Inst), AstraZeneca (Inst), Exelixis (Inst), ViewRay (Inst), BrainLAB (Inst)Travel, Accommodations, Expenses: PeerView Minesh P. MehtaLeadership: OncoceuticsStock and Other Ownership Interests: ChimerixConsulting or Advisory Role: Karyopharm Therapeutics, Mevion Medical Systems, ZappRx, Sapience Therapeutics, XoftPatents, Royalties, Other Intellectual Property: WARF patent 14/934,27, Topical vasoconstrictor preparations and methods for protecting cells during cancer chemotherapy and radiotherapyUncompensated Relationships: Xcision Medical Systems, ViewRay Michael D. ChuongEmployment: Fertility and IVF Center of MiamiHonoraria: ViewRay, Sirtex MedicalConsulting or Advisory Role: ViewRay, Advanced Accelerator ApplicationsSpeakers' Bureau: ViewRay, Sirtex MedicalResearch Funding: AstraZeneca/MedImmune, ViewRayTravel, Accommodations, Expenses: ViewRay Andrew L. SalnerConsulting or Advisory Role: Best Doctors Inc Jamie S. OstroffPatents, Royalties, Other Intellectual Property: UptoDate David G. PfisterConsulting or Advisory Role: Boehringer Ingelheim, IncyteResearch Funding: Boehringer Ingelheim (Inst), AstraZeneca (Inst), Exelixis (Inst), Novartis (Inst), MedImmune (Inst), Merck (Inst), Genentech/Roche (Inst), Lilly (Inst), Bayer (Inst), Eisai (Inst), Regeneron (Inst), Atara Biotherapeutics (Inst), MeiraGTx (Inst), Hookipa Pharma (Inst) Fumiko ChinoThis author is a Consultant Editor for JCO Oncology Practice. Journal policy recused the author from having any role in the peer review of this manuscript. Jillian TsaiHonoraria: Varian Medical IncConsulting or Advisory Role: Varian Medical Systems Erin F. GillespieOther Relationship: eContourNo other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Community-based clinical trial enrollment per quarter (A) before and (B) after implementation (orange line) of altered financial incentives, building a coalition (for metastatic disease) and practice facilitation from April 2018 (Q2) to September 2021 (Q3). Q, quarter.
FIG 2.
FIG 2.
Hispanic patient representation in randomized investigator-initiated radiation oncology clinical trials opened in the MSK Cancer Alliance (n = 3) compared with those open only at MSK (non-Alliance, n = 3). Proportions of Hispanic representation in the US population (on the basis of the 2018 US Census) and on all radiation trials (n = 71) are included for reference. MSK, Memorial Sloan Kettering; RT, radiation therapy.
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References

    1. National Institutes of Health . Policy and Compliance. National Institutes of Health; 2017. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research.https://grants.nih.gov/policy/inclusion/women-and-minorities/guidelines....
    1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials. JAMA. 2004;291:2720–2726. - PubMed
    1. Duma N, Vera Aguilera J, Paludo J, et al. Representation of minorities and women in oncology clinical trials: Review of the past 14 years. J Oncol Pract. 2018;14:e1–e10. - PubMed
    1. Bero EH, Rein LE, Banerjee A, et al. Characterization of underrepresented populations in modern era clinical trials involving radiation therapy. Pract Radiat Oncol. 2021;11:453–459. - PubMed
    1. Institute of Medicine Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care . In: Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Smedley BD, Stith AY, Nelson AR, editors. Washington, DC: National Academies Press (US); 2003. - PubMed

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