Features associated with successful recruitment of diverse patients onto cancer clinical trials: Report from the american college of surgeons oncology group

Kathleen M. Diehl, Erin M. Green, Armin Weinberg, Wayne A. Frederick, Dennis R. Holmes, Bettye Green, Arden Morris, Henry M. Kuerer, Robert A. Beltran, Jane Mendez, Venus Gines, David M. Ota, Heidi Nelson, Lisa A. Newman

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background: The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design: We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999-2009, and analyzed results by race/ethnicity as well as by study design. Results: Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols). Discussion: AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

Original languageEnglish (US)
Pages (from-to)3544-3550
Number of pages7
JournalAnnals of Surgical Oncology
Volume18
Issue number13
DOIs
StatePublished - Dec 2011

Fingerprint

Hispanic Americans
Patient Selection
Clinical Trials
African Americans
Neoplasms
Investigational Therapies
Early Detection of Cancer
Social Class
Surgeons
Randomized Controlled Trials
Therapeutics

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

Features associated with successful recruitment of diverse patients onto cancer clinical trials : Report from the american college of surgeons oncology group. / Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

In: Annals of Surgical Oncology, Vol. 18, No. 13, 12.2011, p. 3544-3550.

Research output: Contribution to journalArticle

Diehl, KM, Green, EM, Weinberg, A, Frederick, WA, Holmes, DR, Green, B, Morris, A, Kuerer, HM, Beltran, RA, Mendez, J, Gines, V, Ota, DM, Nelson, H & Newman, LA 2011, 'Features associated with successful recruitment of diverse patients onto cancer clinical trials: Report from the american college of surgeons oncology group', Annals of Surgical Oncology, vol. 18, no. 13, pp. 3544-3550. https://doi.org/10.1245/s10434-011-1818-9
Diehl, Kathleen M. ; Green, Erin M. ; Weinberg, Armin ; Frederick, Wayne A. ; Holmes, Dennis R. ; Green, Bettye ; Morris, Arden ; Kuerer, Henry M. ; Beltran, Robert A. ; Mendez, Jane ; Gines, Venus ; Ota, David M. ; Nelson, Heidi ; Newman, Lisa A. / Features associated with successful recruitment of diverse patients onto cancer clinical trials : Report from the american college of surgeons oncology group. In: Annals of Surgical Oncology. 2011 ; Vol. 18, No. 13. pp. 3544-3550.
@article{df393581ea9741fa8e6e5a3885d12469,
title = "Features associated with successful recruitment of diverse patients onto cancer clinical trials: Report from the american college of surgeons oncology group",
abstract = "Background: The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design: We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999-2009, and analyzed results by race/ethnicity as well as by study design. Results: Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols). Discussion: AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.",
author = "Diehl, {Kathleen M.} and Green, {Erin M.} and Armin Weinberg and Frederick, {Wayne A.} and Holmes, {Dennis R.} and Bettye Green and Arden Morris and Kuerer, {Henry M.} and Beltran, {Robert A.} and Jane Mendez and Venus Gines and Ota, {David M.} and Heidi Nelson and Newman, {Lisa A.}",
year = "2011",
month = "12",
doi = "10.1245/s10434-011-1818-9",
language = "English (US)",
volume = "18",
pages = "3544--3550",
journal = "Annals of Surgical Oncology",
issn = "1068-9265",
publisher = "Springer New York",
number = "13",

}

TY - JOUR

T1 - Features associated with successful recruitment of diverse patients onto cancer clinical trials

T2 - Report from the american college of surgeons oncology group

AU - Diehl, Kathleen M.

AU - Green, Erin M.

AU - Weinberg, Armin

AU - Frederick, Wayne A.

AU - Holmes, Dennis R.

AU - Green, Bettye

AU - Morris, Arden

AU - Kuerer, Henry M.

AU - Beltran, Robert A.

AU - Mendez, Jane

AU - Gines, Venus

AU - Ota, David M.

AU - Nelson, Heidi

AU - Newman, Lisa A.

PY - 2011/12

Y1 - 2011/12

N2 - Background: The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design: We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999-2009, and analyzed results by race/ethnicity as well as by study design. Results: Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols). Discussion: AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

AB - Background: The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design: We evaluated the accrual patterns for 10 clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999-2009, and analyzed results by race/ethnicity as well as by study design. Results: Eight of 10 protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully recruiting protocols were: (1) studies designed to recruit patients with regional or advanced-stage disease (2 of 2 protocols); and (2) studies that involved some investigational systemic therapy (3 of 3 protocols). Discussion: AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients.

UR - http://www.scopus.com/inward/record.url?scp=82955163224&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=82955163224&partnerID=8YFLogxK

U2 - 10.1245/s10434-011-1818-9

DO - 10.1245/s10434-011-1818-9

M3 - Article

C2 - 21681382

AN - SCOPUS:82955163224

VL - 18

SP - 3544

EP - 3550

JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

SN - 1068-9265

IS - 13

ER -