1 southeast clinical oncology research consortium, inc. (scor) fall meeting marina inn at grande...

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Southeast Clinical Oncology Research Consortium, Inc. (SCOR)

Fall Meeting

Marina Inn at Grande DunesMyrtle Beach, SC

Friday, October 24, 20147:00 am

James N. Atkins, MDJames D. Bearden, III, MD, FACP

Principal Investigators

Funded as an NCI Community Oncology Research Program (NCORP)

SCOR Administrative Office Staff

Susan Tuttle, RN, CCRP Administrator

Robin Burgess, RN, CCRP Program Coordinator Debbie Eaton Fiscal Coordinator Belenda Slate, BAS, CCRP Protocol Specialist Kim Fulton Administrative Assistant

SCOR Community Sites• Anderson, SC• Asheville, NC• Cary, NC• Charleston, SC• Charlotte, NC• Danville, VA• Florence, SC• Gastonia, NC• Goldsboro, NC• Greensboro, NC• Greenville, SC• Hendersonville, NC/Pardee

• Hendersonville, NC/Park Ridge

• High Point, NC• Kingsport, TN• Martinsville, VA• Midlothian, VA• Pinehurst, NC• Rock Hill, SC• Savannah, GA• Spartanburg, SC• Statesville, NC• Winston-Salem, NC

SCOR Community Responsible Investigators (CRIs)

Anderson: David Griffin, MD William Tomlinson, MD

Asheville: Christopher H. Chay, MDCary: Mark L. Graham, II, MDCharleston: James Orcutt, MDCharlotte: Justin Favaro, MDDanville: Qiwei Gai, MDFlorence: Rajesh Bajaj, MDGastonia: Steven Yates, MDGoldsboro: James N. Atkins, MDGreensboro: James Granfortuna, MD Janak Choksi, MDGreenville: Robert Siegel, MD

Hendersonville/Pardee: James Radford, Jr., MDHendersonville/Park Ridge: Raymond Thertulien, MDHigh Point: Mohit Kasibhatla, MDKingsport: Asheesh Shipstone, MDMartinsville: Sreedhar Katragadda, MDMidlothian: William Irvin, Jr., MDPinehurst: Charles S. Kuzma, MDRock Hill: Sashi Naidu, MDSavannah: Harvey Lebos, MDSpartanburg: James D. Bearden, III, MD, FACPStatesville: Ruby Grimm, MDWinston-Salem: Judith O. Hopkins, MD

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SCCC Accrual Credits Year 27 (6/1/13 – 7/31/14)

 Community Accruals

ActualCredits

NCI AssignedQuota Credits

RX 233 172.2 200

CC 289 205 200

CC F/U 108 25.9 n/a

CC Total 230.9

Grand Total 403.1 400

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SCCC Accruals by Research Base 6/1/13 – 7/31/14

Research Base

RX CC Totals

Alliance 57 31 88

CTSU 86 17 155

NRG 65 90 155

SCUSF N/A 87 87

SWOG 10 113 138

 URCC N/A 39 39

WF N/A 20 20

Totals 233 397 630* * does not include: 0 credit accruals and FRP accruals

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Upstate Accrual Credits Year 27 (6/1/13 – 7/31/14)

 Community Accruals

ActualCredits

NCI AssignedQuota Credits

RX 130 122.2 90

CC 165 145 135

Total 267.2 225

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Upstate Accruals by Research Base 6/1/13 – 7/31/14

Research Base

RX CC Totals

Alliance 25 65 90

CTSU 5 3 8

NRG 83 38 121

SCUSF N/A 6 6

SWOG 17 37 54

 URCC N/A 11 11

WF N/A 5 5

Totals 130 165 295* * does not include: 0 credit accruals and FRP accruals

Accruals per Component6/1/13 – 7/31/14

Community RX CC Total

Anderson, SC 5 28 33

Asheville, NC 55 2 57

Cary, NC 15 6 21

Charleston, SC 19 1 20

Charlotte, NC 72 10 82

Danville, VA 1 0 1

Florence, SC 7 3 10

Gastonia, NC 12 22 34

Goldsboro, NC 40 13 53

Greensboro, NC 98 2 100

Greenville, SC 25 3 28

Community RX CC Total

Hendersonville/Pardee, NC 9 3 12

Hendersonville/Park Ridge, NC 2 1 3

High Point, NC 14 0 14

Kingsport, TN 62 1 63

Martinsville, VA 1 9 10

Midlothian, VA 1 1 2

Pinehurst, NC 46 60 106

Rock Hill, SC 0 7 7

Savannah, GA 21 3 24

Spartanburg, SC 88 126 214

Statesville, NC 5 1 6

Winston-Salem, NC 23 46 69

TOTAL 621 348 969

Physician Accrual Awards

June 1, 2013- July 31, 2014

Gold Awards>16 accruals

• James D. Bearden, MD/Spartanburg 67• Drew Monitto, MD/Spartanburg 37• G. Brad Sherrill, MD /Greensboro 31• Charles S. Kuzma, MD/Pinehurst 22• DeQuincy A. Lewis, MD/Greensboro 22• Mark L. Graham, II, MD/Cary 21• Paula A. Lundgren, MD/Gastonia 21

• William R. Mitchell, MD/Charlotte 20• John Doster, MD/Anderson 19• Steven Corso, MD/Spartanburg 18• Samer S. Kasbari, MD/Goldsboro 18• Todd A. Moore, MD/Pinehurst 17• I-Wen Chang, MD/Goldsboro 16• Amy E. Curtis, MD/Spartanburg 16

Gold Awards cont.

Silver Awards10-14 Accruals

• Daniel Fried, MD/Spartanburg 14• Judith O. Hopkins, MD/Winston-Salem 14• Sharmila Mehta, MD/Spartanburg 14• Stephen Dyar, MD/Greenville 12• Patricia C. Griffin, MD/Spartanburg 12• Stephen C. King, MD/Pinehurst 12• Gustav C. Magrinat, MD/Greensboro 12

• Ellen M. Willard, MD/Pinehurst 12• Lance K. Lassiter, MD/Charlotte 11• Dipika Misra, MD/Charlotte 11• Harsha G. Vardhana, MD/Kingsport

11• John W. Byron, MD/Pinehurst

10• Nick G. Chrysson, MD/Winston-Salem 10• Sreedhar Katragadda, MD/Martinsville 10

Silver Awards cont.

Bronze Awards8-9 Accruals

• Jeffery C. Acker, MD/Pinehurst 9• Heather Allen, MD/Spartanburg 9• Jason K. Boyd, MD/Goldsboro 9• Christopher H. Chay, MD/Asheville 8• Susan J. Hines, MD/Winston-Salem 8• James E. Hunter, IV, MD/Spartanburg 8• Michael J. Messino, MD/Asheville 8

• Sushma M. Patel, MD/Pinehurst 8• Daryl W. Pierce, MD/Kingsport 8• Robert A. Pohlmeyer, MD/Pinehurst 8• Michael J. Sundborg, MD/Pinehurst 8• Lia M. Spina, MD/Gastonia 8

Bronze Awards cont.

Accruals per Component8/1/14 – 10/10/14

Community Total

Anderson, SC 0

Asheville, NC 12

Cary, NC 2

Charleston, SC 3

Charlotte, NC 7

Danville, VA 0

Florence, SC 0

Gastonia, NC 7

Goldsboro, NC 12

Greensboro, NC 11

Greenville, SC 5

Community Total

Hendersonville/Pardee, NC 0

Hendersonville/Park Ridge, NC 0

High Point, NC 1

Kingsport, TN 1

Martinsville, VA 1

Midlothian, VA 4

Pinehurst, NC 12

Rock Hill, SC 0

Savannah, GA 3

Spartanburg, SC 10

Statesville, NC 1

Winston-Salem, NC 5

TOTAL 97

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SCOR Accrual Credits Year 01 (8/1/14 – 10/10/14)

Community Accruals NCI AssignedQuota Credits

RX/CC 97 615

Supplemental funding of $150K for 50 extra credits when exceed assigned quota.

SCOR Registrations

NCTN registrations are thru OPEN

Credits for protocols should be given to the research base coordinating the

studies

Examples

• Alliance (composed of CALGB, NCCTG, and ACOSOG legacy studies) registrations must be credited to Alliance

• NRG (composed of NSABP, RTOG, and GOG legacy studies) registrations must be credited to NRG

• SWOG registrations must be credited to SWOG

Other Registrations

Registrations done through OPEN for ECOG-ACRIN or NCIC-CTG studies may be credited to

one of the following research bases:Alliance

NRGSWOG

NCORP Funding Application

• 34 Community Sites– 11 were designated as “Enhanced” CCDR sites– SCOR was honored to be one of the Enhanced

Sites with 2 communities participating initially • Spartanburg, SC – Jay Bearden, MD and Lucy Gansauer• Winston-Salem, NC- Judy Hopkins, MD and Dena Webb

• 12 Minority/Underserved Community Sites– 2 were designated as Enhanced CCDR sites

NCORP Funding

• Received – $2.68 million for clinical trials

44% decrease of proposed budget– $300,000 for Cancer Care Delivery Research

This is a fully funded amount since we are a designated “Enhanced” Community Site

– Supplemental funding of $150,000 (equal to 50 credits) will be released when exceed 615 quota

Effective August 1, 2014New Credit System will apply to

reimbursements

1st Quarter: August 1, 2014 – October 31, 2014

SCOR Funding and Credits

NCTN Per Case Management Funding and NCORP

Crediting Information for Sites

Funding in the NCTN• NCI per case management funds are provided to all

NCTN sites enrolling patients onto NCTN trials via NCI funding mechanism:

DCP NCORP Grant (reflected as credits)

• Non-NCI funding (e.g. industry funding or Foundation) obtained by the Network Groups to supplement trial support is dispersed to sites by the Lead Protocol Organization (LPO). No CTSU or OPEN steps are needed to trigger these funds.

Accrual Requirement

Due to increased credit assignment of 1.6 for the majority of clinical trials, there will be no

individual MD accrual requirement. Community accrual will be assessed on a

quarterly basis. Leadership will communicate with communities having no accruals to

determine issues being faced and ways to increase accruals.

NCI National Clinical Trials Network (NCTN)There is a total of 5 NCTN groups:

4 Adult Groups (legacy cooperative groups - some merged)• Alliance (ACOSOG, CALGB, and NCCTG)• EGOG - ACRIN (ECOG and ACRIN)• NRG (NSABP, RTOG, and GOG)• SWOG (remained solo)1 Pediatric Group• Children’s Oncology Group (COG)

NCI Community Oncology Research Program (NCORP)

Total of 7 NCORP Research Bases• Alliance• ECOG-ACRIN• NRG• SWOG• COG• WF• URCC

Performance Site Codes

• Also referred to as NCI CTEP institutional codes• Site code designated at registration is the location

where the majority of patient assessment (MD visits) for the research study is done. Treatment and/or consenting may be done at another location.

• SCOR has44 Components44 Sub-components

NCI Central Institutional Review Board (NCI-CIRB)

SCOR sites still pending NCI CIRB approvalCharlestonCharlotteHigh PointKingsport

Winston-SalemSites utilizing Spartanburg’s CIRB until approved:

AndersonGreenville

Hendersonville/Park RidgeRock Hill

SCOR NCORP Community Site

Leadership PIs: James N. Atkins, MD James D. Bearden, III, MD, FACP

Co-PIs: Judith O. Hopkins, MD Patricia C. Griffin, MD

SCOR NCORP Community Site

Young Investigators-in-Training: Franklin L. Chen, MD

Amarinthia (Amy) E. Curtis, MD Steven M. Duffy, MD

William (Billy) J. Irvin, Jr., MD Jeremy Kilburn, MD Caio Rocha-Lima, MD

SCCC-Upstate NCORP Community Site

InfrastructureGoverning Council Composed of PIs, Co-PIs, Young Investigators-in-Training, Administrator, and CCDR Coordinator

Executive Board Composed of Governing Council, 25 “Community Responsible Investigators”, and select Administrative Office Staff

Representation at NCTN Research Base Meetings

Alliance: Jim Atkins, MD (med onc)Judith O. Hopkins, MD (med onc)Rick Orr, MD (surgeon) Jeremy Kilburn, MD (rad onc)Amy Curtis, MD (rad onc)Caio Rocha-Lima, MD (med onc)

Representation at NCTN Research Base Meetings

NRG: Jim Atkins, MD (med onc)William J. Irvin, Jr., MD (med onc)Kevin Roof, MD (rad onc)James Burke, II, MD (gyn onc)Volker Stieber, MD (rad onc)

Representation at NCTN Research Base Meetings

SWOG: James D. Bearden, III, MD, FACP (med onc) Charles Kuzma, MD (med onc)

Representation at NCORP Research Base Meetings

Wake Forest: James D. Bearden, III, MD, FACP (med onc) Drew Monitto, MD (rad onc) Steven Duffy, MD (med onc)

Representation at NCORP Research Base Meetings

URCC: Judith O. Hopkins, MD (med onc) Caio Rocha-Lima, MD (med onc) Frank Chen, MD (med onc)

Questions ? ? ?

SCOR Spring Meeting

to be announced

There will be Governing Council and Executive Board meetings.