Early-phase clinical trials in the community

Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group baseline assessment

Howard A. Zaren, Suresh Nair, Ronald S. Go, Rebecca A. Enos, Keith S. Lanier, Michael A. Thompson, Jinxiu Zhao, Deborah L. Fleming, John C. Leighton, Thomas E. Gribbin, Donna M. Bryant, Angela Carrigan, Jennifer C. Corpening, Kimberly A. Csapo, Eileen P. Dimond, Christie Ellison, Maria M. Gonzalez, Jodi L. Harr, Kathy Wilkinson, Andrea M. Denicoff

Research output: Contribution to journalArticle

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Abstract

Purpose: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. Methods: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. Results: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. Conclusion: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

Original languageEnglish (US)
JournalJournal of oncology practice
Volume9
Issue number2
DOIs
StatePublished - Mar 1 2013

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National Cancer Institute (U.S.)
Clinical Trials
Neoplasms
Medical Oncology
Research Ethics Committees
Sample Size

ASJC Scopus subject areas

  • Oncology
  • Oncology(nursing)
  • Health Policy

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Early-phase clinical trials in the community : Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group baseline assessment. / Zaren, Howard A.; Nair, Suresh; Go, Ronald S.; Enos, Rebecca A.; Lanier, Keith S.; Thompson, Michael A.; Zhao, Jinxiu; Fleming, Deborah L.; Leighton, John C.; Gribbin, Thomas E.; Bryant, Donna M.; Carrigan, Angela; Corpening, Jennifer C.; Csapo, Kimberly A.; Dimond, Eileen P.; Ellison, Christie; Gonzalez, Maria M.; Harr, Jodi L.; Wilkinson, Kathy; Denicoff, Andrea M.

In: Journal of oncology practice, Vol. 9, No. 2, 01.03.2013.

Research output: Contribution to journalArticle

Zaren, HA, Nair, S, Go, RS, Enos, RA, Lanier, KS, Thompson, MA, Zhao, J, Fleming, DL, Leighton, JC, Gribbin, TE, Bryant, DM, Carrigan, A, Corpening, JC, Csapo, KA, Dimond, EP, Ellison, C, Gonzalez, MM, Harr, JL, Wilkinson, K & Denicoff, AM 2013, 'Early-phase clinical trials in the community: Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group baseline assessment', Journal of oncology practice, vol. 9, no. 2. https://doi.org/10.1200/JOP.2012.000695
Zaren, Howard A. ; Nair, Suresh ; Go, Ronald S. ; Enos, Rebecca A. ; Lanier, Keith S. ; Thompson, Michael A. ; Zhao, Jinxiu ; Fleming, Deborah L. ; Leighton, John C. ; Gribbin, Thomas E. ; Bryant, Donna M. ; Carrigan, Angela ; Corpening, Jennifer C. ; Csapo, Kimberly A. ; Dimond, Eileen P. ; Ellison, Christie ; Gonzalez, Maria M. ; Harr, Jodi L. ; Wilkinson, Kathy ; Denicoff, Andrea M. / Early-phase clinical trials in the community : Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group baseline assessment. In: Journal of oncology practice. 2013 ; Vol. 9, No. 2.
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abstract = "Purpose: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. Methods: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. Results: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. Conclusion: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.",
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AU - Nair, Suresh

AU - Go, Ronald S.

AU - Enos, Rebecca A.

AU - Lanier, Keith S.

AU - Thompson, Michael A.

AU - Zhao, Jinxiu

AU - Fleming, Deborah L.

AU - Leighton, John C.

AU - Gribbin, Thomas E.

AU - Bryant, Donna M.

AU - Carrigan, Angela

AU - Corpening, Jennifer C.

AU - Csapo, Kimberly A.

AU - Dimond, Eileen P.

AU - Ellison, Christie

AU - Gonzalez, Maria M.

AU - Harr, Jodi L.

AU - Wilkinson, Kathy

AU - Denicoff, Andrea M.

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N2 - Purpose: The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) formed an Early-Phase Working Group to facilitate site participation in early-phase (EP) trials. The Working Group conducted a baseline assessment (BA) to describe the sites' EP trial infrastructure and its association with accrual. Methods: EP accrual and infrastructure data for the sites were obtained for July 2010-June 2011 and 2010, respectively. Sites with EP accrual rates at or above the median were considered high-accruing sites. Analyses were performed to identify site characteristics associated with higher accrual onto EP trials. Results: Twenty-seven of the 30 NCCCP sites participated. The median number of EP trials open per site over the course of July 2010-June 2011 was 19. Median EP accrual per site was 14 patients in 1 year. Approximately half of the EP trials were Cooperative Group; most were phase II. Except for having a higher number of EP trials open (P = .04), high-accruing sites (n = 14) did not differ significantly from low-accruing sites (n = 13) in terms of any single site characteristic. High-accruing sites did have shorter institutional review board (IRB) turnaround time by 20 days, and were almost three times as likely to be a lead Community Clinical Oncology Program site (small sample size may have prevented statistical significance). Most sites had at least basic EP trial infrastructure. Conclusion: Community cancer centers are capable of conducting EP trials. Infrastructure and collaborations are critical components of success. This assessment provides useful information for implementing EP trials in the community.

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