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Southeast Cancer Control Consortium Spring Meeting. The Proximity Hotel Greensboro, NC Friday, April 25, 2014 8:30 am James N. Atkins, MD Principal Investigator Judith O. Hopkins, MD Co-Principal Investigator. - PowerPoint PPT Presentation
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Southeast Cancer Control Consortium Spring Meeting
The Proximity HotelGreensboro, NC
Friday, April 25, 20148:30 am
James N. Atkins, MDPrincipal Investigator
Judith O. Hopkins, MD Co-Principal Investigator
A Community Clinical Oncology Program (CCOP) funded by the National Cancer Institute (NCI)
New SCCC Physicians • Asheville, NCAshley Case, MD - Gyn Onc Blair Harkness, MD - Gyn Onc David Hetzel, MD - Gyn Onc Timothy Vanderkwaak, MD - Gyn Onc
• Charlotte, NCIlan Avin, MD - SurgeonNusrat Chaundhary, MD – Med OncAdam Kuykendal, MD – Med OncPeter Turk, MD - Surgeon
• Danville, VA Ashantice Higgins, MD - Med Onc
• Gastonia, NCJohn Heinzerling II, MD - Rad Onc
• Goldsboro, NCDebra Miller, MD – Med Onc
• High Point, NCBernard Chinnasami, MD - Med OncGrace Kim, MD - Rad Onc
• Savannah, GA James Burke, II, MD - Gyn Onc James Garber, MD - Surgery Patrick Hammen, MD - Surgery Robert Jones, MD - Surgery Guy Petruzelli, MD - Surgery Scott Purinton, MD - Gyn Onc Raymond Rudolph, MD - Surgery Christopher Senkowski, MD - Surgery
New Community Leader
Greensboro, NC: Community Leader James Granfortuna, MD
6
SCCC Accrual Credits Year 27 (6/1/13 – 2/28/14)
Community AccrualsProjected/Actual
ActualCredits
NCI AssignedQuota Credits
CreditsNeeded
RX 183/135 97.1 200 102.9
CC 183/148 131.5 200
CC F/U 63 15.4 n/a
CC Total 146.9 53.1
7
Year 26 Accrual by Research Base 6/1/13 – 2/28/14
Research Base
RX CC Totals
Alliance (CALGB) 31 21 52CCCWFU N/A 13 13
CTSU 49 9 58NSABP 38 40 78RTOG 7 11 18SCUSF N/A 9 9 SWOG 10 88 98 URCC N/A 20 20
Totals 135 211 346* * does not include: 0 credit accruals or follow-up FRP accruals: 129
Accrual Requirements
Normally accrual projections for each component are based on the number of
current SCCC members within a component
Example: 2 x # MDs = projection
Revised Accrual Requirement
Due to the lack of available protocols for common diseases (breast, colon, and lung),
the component accrual requirement will not be enforced for the current grant year
(6/1/13 to 5/31/14).We continue to encourage investigator
participation in clinical trials for all cancer patients.
Baseli
ne
1st Q
uarter
2nd Q
uarter
3rd Q
uarter
4th Q
uarter
0
100
200
300
41.1
78.797.1
0
50
100
150
200
SCCC TREATMENT CREDIT ACCRUALACTUAL vs NCI QUOTA
06/01/13 - 02/28/14
ACTUALNCI QUOTA
TREA
TMEN
T C
RED
ITS
Treatment Credit Accrual
Baseli
ne
1st Q
uarte
r
2nd Q
uarte
r
3rd Q
uarte
r
4th Q
uarte
r0
100
200
300
66.2
120.4146.9
0
50
100
150
200
SCCC CANCER CONTROL CREDIT ACCRUALACTUAL vs NCI QUOTA
06/01/13 - 02/28/14
ACTUAL
NCI QUOTA
CAN
CER
CO
NTR
OL
CR
ED
ITS
Cancer Control Credit Accrual
SCCC 6 Month Accrual6/1/13-11/30/13
RX Accrual 108 = 78.7 CreditsCC Accrual 163 = 120.4 Credits
SCCC 9 Month Accrual6/1/13 – 2/28/14
RX Accrual 135 = 97.1 CreditsCC Accrual 211 = 146.9 Credits
SCCC Accruals per Component6/1/13 – 2/28/14
Community RX CC Industry Total ComponentAccrual Req
Asheville, NC 13 4 27 44 36
Cary, NC 5 7 0 12 4
Charleston, SC 9 4 2 15 30
Charlotte, NC 16 26 22 64 38
Danville, VA 1 0 0 1 4
Florence, SC 2 3 0 5 10
Gastonia, NC 5 5 0 10 16
Goldsboro, NC 14 10 0 24 16
Greensboro, NC 24 21 28 73 44
Hendersonville, NC 1 6 0 7 12
SCCC Accruals per Component6/1/13 – 2/28/14
Community RX CC Industry Total ComponentAccrual Req
High Point, NC 2 2 10 14 12
Kingsport, TN 16 1 30 47 30
Martinsville, VA 1 1 0 2 4
Pinehurst, NC 9 19 10 38 14
Richmond, VA 0* 0 0 0 8
Savannah, GA 4 4 0 8 20
Statesville, NC 3 0 0 3 8
Winston-Salem, NC 10 43 0 53 46
Total 135 156 129 420 352
* New Component - 1st registration March 2014 QOL registrations not included
Pharmaceutical Management Branch (PMB)Oral Drug Accountability Record Form (DARF)
New NCI Oral DARF available March 1, 2014
• SCCC has pre-populated NCI Oral DARFs and Regular IV DARFs• Available on SCCC member website – use following links to
obtain:View Community Clinical Trials →Disease →Protocol →Related Documents →Drug Listing = DARF (ability to complete DARF online and
save as document)
Pharmaceutical Management Branch Oral Drug Accountability Record Form (DARF)
NCI National Clinical Trials Network (NCTN)There will be a total of 7 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)2 Cancer Center Research Base Groups from the following:• CCCWFU, MD Anderson, SunCoast, and URCC
National Clinical Trials Network (NCTN)
• Became effective March 1, 2014• Transition process did not go as smoothly as NCI expected• CTSU and all research bases experienced difficulties• Many hours spent in SCCC Operations Office thru phone calls and emails to resolve issues – over 300 SCCC
members to input info into system• All components and their affiliates/clinics/etc. have performance site codes
NCTN Working Group
• Meeting held at NCI in Rockville, MD on Wednesday, March 26
• Composed of 2 Co-Chairs and 28 extramural members – Jim Atkins, MD is a member
• Conducted 4 face-to-face meetings to date• One more meeting may be conducted• Have reviewed all clinical trials within the NCI
portfolio
NCTN Working Group
Responsibilities:• Assess strength and balance of active NCTN
clinical trials portfolio• Recommend new strategic priorities and
directions• Review and assess the Clinical Trials Working
Group evaluation process and results• Provide strategic advice to enhance NCTN
clinical trial operations
NCTN Working Group
Meeting highlights:• One of the Steering Committees now
has new membership• All clinical trials accruing over 1000
patients are on hold
NCTN Working Group(Meeting Highlights cont.)• Total registrations for all 4 adult groups are
12,000 pts/year (3,000/group) – down from 25,000-30,000/year in the past (12,000 does not include accruals to Match or Alchemist)
• Steering Committees will rank Phase II and III trials (select protocols on hold) plus assess funding and # patients going on clinical trials
Performance Site Codes
• Also referred to as NCI CTEP institutional codes• Utilized for patient registrations• NCI wants the capability of identifying where
patients are cared for/treated/consented• 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.
CCOPSYSThe database system utilized to store/access CCOP information.
Provides:
• CCOP Description, Components (institutions), Persons (SCCC members - MDs, CRPs, RNs, etc.), Role Assignment within Operations Office, Research Base Rosters, History of SCCC, and required membership documents
• Quarterly Accrual Submission and Yearly Budget
• Historical Accrual Reports and Demographics of Accruals (male and female)
• Meeting presentations from CCOP PI/Administrators meetings
NCI Central Institutional Review Board (NCI-CIRB)
Sole IRB of record responsible for study review as well as review of local context considerations via study-specific worksheets
Local Institutional Key Responsibilities:• Report unanticipated problems or serious/continuing noncompliance• Merging local boilerplate text/language into
CIRB-approved consent form
NCI Central Institutional Review Board (NCI-CIRB)
SCCC Component NCI-CIRB Involvement/Progress• Six components are presently utilizing• Seven components have submitted applications
– pending approval• Five components are in the process of
completing the applicationApproximate #s since approval process changes
weekly/monthly
NCI-CIRB
Three current CIRBs and one more added in future:• Adult CIRB - Late Phase (16 members) – reviews all
Phase III studies (since 2001)• Adult CIRB - Early Phase (10 members) – reviews
early phase studies (since 2013)• Pediatric CIRB (16 members) – reviews all COG
studies (since 2004)• Cancer Control/Prevention CIRB – member
solicitation has begun to form CIRB during 2014
Components Involved in ACOSOG and GOG
ACOSOG: GOG:Asheville AshevilleCharlotte CharlotteSavannah Greensboro
KingsportPinehurstSavannahWinston-Salem
New Member: Hope Women’s Cancer Center - ACOSOG and GOGparticipating physicians located in Asheville, NC
ACCRU through Alliance
• Participation now available through SCCC for ACCRU studies since drug is distributed directly to components by Biologics for many studies
• One recurrent/metastatic breast cancer study available (RU011201I) with more to come
- One component approved to participate - Several components are applying for participation
Alliance Executive Committee RetreatMarch 28-29, 2014
Miami, FL
• Group Chair: Monica M. Bertagnolli, MD• All 4 NCTN group chairs composed a letter to
Harold Varmus, MD (NCI Director) that addressed poor protocol selection, decreased number of trials, and IOM recommendations.
• ASCO article received via Alliance membership– Letter addressed budget cuts, end of CCOP funding,
and lack of clinical trial research available
Summary
• NCTN Research Bases must be unified and work together
• Majority of clinical trials will be Phase II although the need for Phase III has been emphatically expressed
• Credit the majority of your registrations through CTSU to Alliance
Summary cont.
• Message conveyed: “clinical trial system is being dismantled in the US”
• Consider increased participation in industry trials
• NCTN Research Bases are planning to conduct large Phase III trials through foundation support if NCI does not support the trial
NCI Community Oncology Research Program (NCORP)
Timeline:• NCORP Application received at NCI on January 8, 2014• Peer Review scheduled for Community Sites is April 24-25,
2014 with scoring posted within a few days – the lower the score the better (ideal 20-30)
• Application scores along with summary statement including comments from reviewers will come later
• NCI Advisory Review (2nd level) scheduled for June 2014 ? determines funding
• NCORP anticipated start date around August 1, 2014
New Documents
Drafted documents:• ByLaws• Consortium Agreement• Governing Council Responsibilities• Executive Board Responsibilities• Component Responsible Investigator
Responsibilities• Study Coordinator Responsibilities
CCOP to NCORP Transition• CCOP funding ends May 31, 2014 – able to pay all
CCOP expenses up to that point (payment may occur in June for some expenses)
• SCCC will apply for “no-cost extension” of funds (leftover funds) remaining from CCOP award for 6/1/13-5/31/14
• All expenses from 6/1/14 until NCORP funding is awarded will come from leftover CCOP funds
• All accruals from 6/1/14 will be extended CCOP credits
CCOP to NCORP Transition
• SCCC Operations Office will continue to function as normal
• Registrations will still occur to protocols and will be considered accruals to NCORP from June 1, 2014 forward
• Official merge of SCCC with Upstate will occur when NCI awards NCORP funding – have legal matters to address with the merge
SCCC-Upstate NCORP Community Site
Introductions on Planned Infrastructure
PIs: James N. Atkins, MD James D. Bearden, III, MD, FACP
(Spartanburg, SC)
Co-PIs: Judith O. Hopkins, MD (Winston-Salem, NC)
Patricia C. Griffin, MD (Spartanburg, SC)
SCCC-Upstate NCORP Community Site
Young Investigators-in-Training: Franklin L. Chen, MD (Winston-Salem, NC) Amarinthia (Amy) E. Curtis, MD (Spartanburg, SC) Steven M. Duffy, MD (Richmond, VA) William (Billy) J. Irvin, Jr., MD (Midlothian,
VA) Sharmila P. Mehta, MD (Spartanburg, SC) Sarah I. Vidito, MD (Spartanburg, SC)
SCCC-Upstate NCORP Community Site
InfrastructureGoverning Council Composed of PIs, Co-PIs, Young Investigators-in-Training, Administrators, and CCDR Coordinator
Executive Board Composed of Governing Council, 23 “Community Responsible Investigators” (formerly known as “Community Leaders”), and select Administrative Office Staff
Representation at NCTN Research Base Meetings (Pending Funding)
Alliance: Jim Atkins, MD (med onc)Judith O. Hopkins, MD (med onc)Rick Orr, MD (surgeon) - UpstateSarah Vidito, MD (med onc) –
Upstate
Representation at NCTN Research Base Meetings Pending Funding
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 Pending Funding
SWOG: James D. Bearden, III, MD, FACP(med onc) - UpstateCharles Kuzma, MD (med onc)Amy Curtis, MD (med onc) –UpstateGary Spencer, MD (hem) - Upstate
Representation at NCTN Cancer Center Research Base (CCRB) Meetings Pending Funding
CCRB #1: James D. Bearden, III, MD, FACP (med onc) - Upstate
Drew Monitto, MD (rad onc) - Upstate
Steven Duffy, MD (med onc)
Representation at NCTN Cancer Center Research Base (CCRB) Meetings Pending Funding
CCRB #2: Judith O. Hopkins, MD (med onc) Sharm Mehta, MD (med onc) -
UpstateFrank Chen, MD (med onc)
Questions ? ? ?
SCCC Fall MeetingMarina Inn at Grand Dunes, Myrtle Beach, SC
October 23 – 25, 2014
Please make every effort to attend this vital meeting as final terms of the NCORP award and the merger with Upstate Carolina will be presented in detail. There will be Governing Council and Executive Board meetings.