Clinical Trial

. 2018 Jan;49(1):84-89.

doi: 10.1161/STROKEAHA.117.018063. Epub 2017 Nov 30.

Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Affiliations

¹ From the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
² From the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.). brott.thomas@mayo.edu.

PMID: 29191852
PMCID: PMC5823533
DOI: 10.1161/STROKEAHA.117.018063

Clinical Trial

Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Alice J Sheffet et al. Stroke. 2018 Jan.

. 2018 Jan;49(1):84-89.

doi: 10.1161/STROKEAHA.117.018063. Epub 2017 Nov 30.

Affiliations

¹ From the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.).
² From the Department of Surgery, Rutgers, the State University of New Jersey, Newark (A.J.S., S.E.H., L.F., T.G.B.); Departments of Biostatistics (G.H.) and Epidemiology, School of Public Health (V.J.H.), University of Alabama at Birmingham; Division of Vascular Surgery, Southern Connecticut Vascular Center, Middletown Hospital (A.S.); Section of Vascular Surgery, St. Michael's Medical Center, Newark, NJ (Z.J.); Division of Vascular Surgery and Endovascular Therapy, Keck Medical Center, University of Southern California, Los Angeles (F.W.); Department of Neurology, Houston Methodist Neurological Institute, TX (D.C); Department of Neurology, Medical University of South Carolina, Charleston (J.H.V.); and Mayo Clinic Florida, Jacksonville (M.E.L., T.G.B.). brott.thomas@mayo.edu.

PMID: 29191852
PMCID: PMC5823533
DOI: 10.1161/STROKEAHA.117.018063

Abstract

Background and purpose: We report patient enrollment and retention by race and ethnicity in the CREST (Carotid Revascularization Endarterectomy Versus Stent Trial) and assess potential effect modification by race/ethnicity. In addition, we discuss the challenge of detecting differences in study outcomes when subgroups are small and the event rate is low.

Methods: We compared 2502 patients by race, ethnicity, baseline characteristics, and primary outcome (any periprocedural stroke, death, or myocardial infarction and subsequent ipsilateral stroke up to 10 years).

Results: Two hundred forty (9.7%) patients were minority by race (6.1%) or ethnicity (3.6%); 109 patients (4.4%) were black, 32 (1.3%) Asian, 2332 (93.4%) white, 11 (0.4%) other, and 18 (0.7%) unknown. Ninety (3.6%) were Hispanic, 2377 (95%) non-Hispanic, and 35 (1.4%) unknown. The rate of the primary end point for all patients was 10.9%±0.9% at 10 years and did not differ by race or ethnicity (P_inter>0.24).

Conclusions: The proportion of minorities recruited to CREST was below their representation in the general population, and retention of minority patients was lower than for whites. Primary outcomes did not differ by race or ethnicity. However, in CREST (like other studies), the lack of evidence of a racial/ethnic difference in the treatment effect should be interpreted with caution because of low statistical power to detect such a difference.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Keywords: carotid arteries; diversity; endarterectomy; myocardial infarction; stents; stroke.

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Figures

**Figure 1**
Primary endpoint through 10 Years by Race x-axis: Follow-up Time (years) y-axis: % Event Free Race (Non-White): Race (White)

formula image — **Figure 1**
Primary endpoint through 10 Years by Race x-axis: Follow-up Time (years) y-axis: % Event Free Race (Non-White): Race (White)

**Figure 2**
Primary endpoint through 10 years by ethnicity x-axis: Follow-up Time (years) y-axis: % Event Free Ethnicity (Hispanic): Ethnicity (Non-Hispanic):

See this image and copyright information in PMC

References

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Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Affiliations

Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Authors

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Abstract

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References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

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Medical