Document ByevqJm7ybx4KY2J1MvwOQJa4
From: Sent: To:
Cc:
Subject: Attach:
George Woodall <Woodallg@api.org>
Tuesday, December 18, 2001 7:03 PM (GMT)
'BenzConsort-OC@listserve.api.org' <B enzConsort-OC@api.org>; 'BenzConsortTC@listserve.api.org' <BenzConsort-TC@api.org>
Richard Irons (E-mail) <richard.irons@uchsc.edu>; Otto Wong (E-mail) <OttoWong@ao1.com>; Thomas Armstrong (E-mail)<twarmst@erenj.com>; Robert Schnatter Ph. D. (E-mail)<arschna@fpe.erenj.com>
IMPORTANT Call Reminder - (Revised Agenda and Meeting Materials)
Proj ectCostEstimate.xls; Epi StudyAdditionalBudget.xls; IronsPost-SRP-Budget.XLS; EMBSI-AddtionalExpense.xls
Oversight and Technical Committee Members;
The Agenda for the conference call for tomorrow has been revised and is shown below. This call will be a joint call of both the Oversight and Technical Committees due to the need for input from both sets of members on the important issue of authorizing the researchers to go forward with IRB review, and the path forward on authorizing the additional costs associated with the protocol review process. Details for the call are also shown below. Four spreadsheets are attached for the first main item on the agenda (Project Budget) which will involve both the Oversight and Technical Committees.
ProjectCostEstimate.xls - shows the overall revised budget estimate for the project. EpiStudyAdditionalCosts.xls - shows the additional costs that are specific to the Case-Control Study; refer
to the Consortium Web page for the original cost estimate for this work. The line item for the Case-Control Study costs in the overall budget (first spreadsheet) includes both the original estimate (adjusted for inflations) and the additional costs. IronsPost-SRP-Budget.xls - shows the additional costs associated with the Disease Progression (DP) and Molecular Epidemiology (ME) Studies, with details indicating which costs have increased and decreased. This has been added to the original estimates provided in the overall budget (1st spreadsheet). EMBSI-AdditionaICosts.xls - shows the exposure assessment work being done by EMBSI that is reflected in the estimates from Dr. Irons as a separate line item in his spreadsheet (3rd spreadsheet).
Conference Call Oversight and Technical Committees - Benzene Health Research Consortium
Date/Time: Wednesday, December 19, 2001, 11:00 AM - 1:00 PM EST Call-in Number: (703)736-7274 Moderator: George Woodall, API Confirmation Number: 5734738 Call Title: Mi lestones
Agenda
Discussion of protocol changes and budgetary impacts from the SRP review. o Need for approval of the Disease Progression and Molecular Epidemiology Protocols to go the University of Colorado IRB for review ASAP (Irons/Beatty) o Need for approval of increases in costs to be adopted by the Oversight Committee and definition of the path forward (Burnett/Twerdok) o Need for approval of funds based on increased costs prior to authorizing contracts for 2002 (Woodall/Wong)
SHELL-MCCLURG-051902
Establishment of Milestones for tracking progress on the research project and other Technical Committee
activities - please see the Gantt Chart of Project Timeline (http://www.api.org/benzene-
consortium/Project'1020Progress/TimelineBenzeneHealthResearchNov2001.pdf) on the Consortium Web Page
(Username =. J; Password = I
).
Discuss need for follow-on meeting or conference call (All).
George M. Woodall, Ph.D. Senior Toxicologist American Petroleum Institute 1220 L Street, NW Washington, DC 20005
Tel. (202)682-8067 Fax. (202)682-8031
*********************
Visit the New www.api.org.
SHELL-MCCLURG-051903
A
J.-
2 3 4 5 DP Study Design and Control Changes 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 ME Study Design Changes 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 Glycophorin A Mutation Assay Costs 47 48 Total All Changes 49 50 Notes: 51 52 53 54 55 56 57 58 59 60 61
B IC
Remove AML controls from DP Study
Addition of controls for AA and MDS Elimination of "mild cases"
Changes in testing protocol
Subject/history costs
Increase AA and MDS by 10% AA/MDS/AML
NHL
Subtotal SRP changes Exposure assessment
Subtotal exposure assessment Total DP Study
China personnel IH supplies EMBSI cost increases
Phase 1 Phase 2a
Phase 2b Exposure assessment Total ME Study
Increase subjects to 1,600
Increase subjects to 2,000
Cost of making/storing cell pellets Remove FISH and banded analysis
Increase subject compensation Flt3 Eliminate GST-T1 and CYP2E1
China personnel IH supplies
1 2 3
4
5
6 7
SHELL-MCCLURG-051904
D
J.- Incremental Changes in DP and ME Study Budgets
2 3 4 5 6 7 8 9 10 11 12 13 Flt3 14 Special stains 15 Presentation system 16 17 Eliminate HBV 18 HHV8 19 LDH 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Test costs 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 Provides for potential increased accrual of AA/MDS cases from 23 Central District Hospitals 52 SRP recommended removal of HBV assays and addition of HHV8 and HHV6. We haved added only HHV8. 53 Provides additional Shanghai staffing to a) cover 2:1 controls for DP and b) follow the 54 55 Expanded to cover AMLlNHL with the same sampling and assessment design, resulting in 56 57 Provides for additional field time for Shanghai staff development and oversight, inorder to follow same 58 59 Increases in study group size recommended by Chinese and SRP. 60 FISH and banded cytogenetic analysis of peripheral blood in Phase 2a eliminated as cost savings. 61
IE
same EA design for the AMLI NHL study. approximately 2 x the number of subjects to evaluate compared to the original DP study plan. exposure assessment design for the AMLlNHL study, and additional sites in ME study. DNA pellets will be prepared and stored for selective retrespective FISH analysis based on 2b results.
SHELL-MCCLURG-051905
FIG
J.-
2
H
3
4 Incremental cost
5 Total 5 years per year
6
7 $ (40,000) $
(8,000)
8 $ 44,000 $
8,800
9 $ (77,000) $ (15,400)
10 $ 56,000 $
11,200 Note 1.
11
12
13 $ 85,000 $
17,000
14 $ 67,000 $
13,400
15 $ 20,000 $
4,000
16
17 $ (10,000) $
(2,000)
18 $ 90,000 $
18,000 Note 2.
19 $ 10,000 $
2,000
20 $ 245,000 $
49,000
21
22 $ 342,000 $
68,400 Note 3.
23 $ 210,000 $
42,000 Note 4.
24 $ 556,000 $ 111,200 Note 5.
25 $ 1,108,000 $ 221,600
26
27 $ 1,353,000 $
49,000
28
29
30
31 $ 53,000 OvertwQ yrs Note 6.
32
33 $ 86,000 $
17,200
34 $ 25,000 $
5,000
35 $ 21,000 $
4,200 Note 7a.
36 $ (592,000) $ (118,400) Note 7b.
37
38 $ 40,000 $
8,000
39 $ 27,000 $
5,400
40 $ (19,000) $
(3,800)
41
42 $ 171,000 $
34,200 Note 8.
43 $ 51,000 $
10,200 Note 9.
44 $ (137,000) $ (27,400)
45
46 $ 377,000 $
75,400
47
48 $ 1,593,000 $ 318,600
49
50
51
52
53
54
55
56
57
58
59
60
61
SHELL-MCCLURG-051906
A Bc
62
63 8 64 65 9 66 67 * 68
SHELL-MCCLURG-051907
D
62
63 Revised to cover more facilities to provide the expanded numbers needed for power, and 64 65 Includes additional sites to meet size projections, and thus additional supplies for the additional survey work. 66 67 Dose-response analysis of banded cytogenetics and FISH to Phase 2a: Add $3,200,000 68 Dose-response analysis of clonal cytogenetic lesions only to Phase 2a: Add $1,500,000
E If these studies are performed they will be funded through independent sources.
additional logistics issues due to the probability of sites outside of Shanghai.
SHELL-MCCLURG-051908
ANLL and NHL Case-control Studies Additioanl Budget Estimate for Exposure Assessment
Applied Health Sciences, Inc.
11128/2001
A 1 Labor b~ categor~ 2 3 Category 4 Chief Epidemiologist (PI) 5 Statistical programmer 6 Research assistant 7 Consulting industrial hygienist 8 Total labor for regular activities (2001 $) 9 10 11 Meetings/working tri[!s (time & ex[!enses) 12 13 14 Meetings in China (8 days @) 15 Meetings in USA (3 days @) 16 Total for meetings/working trips (2001 $) 17 18 Total in 2001 $ (labor and trips) 19
20 21 22 Yearl~ budget estimates with a 5% annual adjustment 23 24 Budget by calendar year 25 Total (with 5% annual adjustment)
BC D E F G H I J K L
Hourly rate in 2001 $ $280 $120 $90 $200
Year 1
Hours
Amount
80 $22,400
20 $2,400
20 $1,800
120 $24,000
$50,600
Year 2
Hours
Amount
40 $11,200
20 $2,400
20 $1,800
120 $24,000
$39,400
Year 3
Hours
Amount
40 $11,200
20 $2,400
20 $1,800
100 $20,000
$35,400
Year 4
Hours
Amount
40 $11,200
20 $2,400
20 $1,800
100 $20,000
$35,400
Year 5
Hours
Amount
40 $11,200
20 $2,400
20 $1,800
100 $20,000
$35,400
Unit cost in 2001 $
$26,000 $12,000
Year 1 No. Amount
1 $26,000 1 $12,000
$38,000
$88,600
Year 2 No. Amount
2 $52,000 1 $12,000
$64,000
$103,400
Year 3 No. Amount
1 $26,000 1 $12,000
$38,000
$73,400
Year 4 No. Amount
1 $26,000 1 $12,000
$38,000
$73,400
Year 5 No. Amount
1 $12,000 $12,000
$47,400
Year 2002 $93,030
Year 2003 $113,999
Year 2004 $84,970
Year 2005 $89,218
Year 2006 $60,496
SHELL-MCCLURG-051909
MN
1
2 Total
3 Hours
Amount
4 240 $67,200
5 100 $12,000
6 100 $9,000
7 540 $108,000
8 $980 $196,200
9
10
11
12 Total
13 No. Amount
14 5 $130,000
15 5 $60,000
16 10 $190,000
17
18 $386,200
19
20
21
22
23
24 Total
25 $441,712
ANLL and NHL Case-control Studies Additioanl Budget Estimate for Exposure Assessment
Applied Health Sciences, Inc.
11128/2001
SHELL-MCCLURG-051910
Project Total Cost Estimate
A B CD
1 Updated: December 18, 2001
2
Original Cost Estimate Revised Cost Estimate
3 Item
(Jan. 2001)
(Dec. 2001)
4 Case-Control Study
$1,761,000
$2,283,094
5 DP & ME Studies
$15,109,000
$16,702,000
6
Total Research Costs
$16,870,000
$18,985,094
7 Scientific Review Panel
$648,000
8 Ethics Review Panel
$216,000
9 External Pathology Workgroup
$66,000
10
Total Panel Costs
$450,000
$930,000
11 API Seed Monies
$500,000
12 Outside Counsel
$500,000
13 Public Affairs
$1,000,000
14
Miscellaneous Costs
$500,000
$1,500,000
15 Subtotal
$17,820,000
$21,415,094
16
API Overhead (5%)
$891,000
$1,070,755
17 GRAND TOTAL
$18,711,000
$22,485,849
18
19 Notes/Assumptions:
20 - The total research costs have changed as a result of the protocol review
21 - Panel costs assume that there will be only one face-to-face meeting for each
22 - Miscellaneous costs for outside counsel and media relations are based solely
Date Printed: &[DATE]
SHELL-MCCLURG-051911