Document 2JDx9Obm2xqZRew19vjnEdzob
PROGRESS REPORT ON THE BUDGET July 2006
Shanghai Health Study I. DISEASE PROGRESSION FOR APLASTIC ANEMIA,
MYELODYSPLASTIC SYNDROME, ACUTE MYELOGENOUS LEUKEMIA AND BENZENE POISONING IN SHANGHAI, CHINA II. MOLECULAR EPIDEMIOLOGY OF BENZENE-EXPOSED WORKERS IN SHANGHAI, CHINA III. EXPOSURE ASSESSMENT
Richard D. Irons
1
SH ELL-MCCLU RG-058289
EXECUTIVE SUMMARY
A. Overall Status of Budget Attached is an official summary of the overall budget for the period ending June 30, 2006. Table 1 reflects actual expenditures for the period. For the first time these exceeded
budgeted projections in all categories except for personnel (Table 1).
Table 1. Budget Summary (Reporting Period)
Personnel
Budgeted! $236,350
Expenditures Variance
$227,105
$9,245
Operating Expenses $235,580
$265,524
($29,914)
Subcontracts
$1,454,051 $1,675,639 ($221,588)
Travel
$500
$0
$500
Equipment
$0
$0
$0
Indirect
$122,832
$127,042
($4210)
TOTALS
$2,049,313 $2,295,310 ($245,997)
!The budgeted amounts are the sum of each category from Jan-06 thru Jun-06.
Table 2. Budget Summary (Entire Project)
Budgeted2
Expenditures Variance
Personnel
$ 2,399,955 $2,406,356
($t:; 4011 '-'''J - /
Operating Expenses $ 1,961,966 $1,822,928 $139,038
Subcontracts
$ 8,652,639 $ 8,297,249 $355,390
Travel
$ 10,493 $9,098
$1,395
Equipment
$ 1,383,490 $1,383,490 $0
Indirect
$ 1,166,418 $1,129,385 $37,033
TOTALS
$ 15,574,962 $15,048,506 $526,455
2 The budgeted amounts are the sum of each category from Dec-Ol thru Jun-06.
2 SH ELL-MCCLU RG-058290
Subcontract Summary (Entire Project)
Subcontracts
Expenditures (Dec Ol-Jun 06)
Fudan University $
5,121,580
IPHS $
170,077
SMCDC $
153,004
EMBSI $
2,515,754
Children's Hospital Cincinnati $
336,834
Total $
8,297,249
B. Budget Analysis
The increased rate of expenditures experienced during this reporting period can be attributed to a combination of: 1) an increase in case load coinciding with increases in reagent costs; 2) the unexpected frequency of excluded cases which are approaching 30% in some categories (i.e. nutritional deficiencies); and 3) a large increase in efforts and expenditures in ME factory monitoring, exposure assessment and EA simulation exercises. However, as I discussed by telephone in April, the loss of critical personnel coupled with our inability to contract additional manpower has significantly slowed progress and has had a major impact on all of these initiatives by exacerbating inefficiencies and requiring "work-arounds" to complete tasks on the critical path. The increased rate of expenditures is not reflected in the overall budget summary (Table 2) because of the previous budgetary surplus. Projected costs for the remainder of the project are outlined in Table 3. Although projected expenditures are expected to stay within the overall budget through December 2006, we anticipate the possibility of a shortfall approaching as much as $450,000 by June 2006. These projections assume case accrual ends December 31, 2006 independent of study case accrual target goals.
Table 3. Projected Budget (Remainder of Project) based on current projections
Personnel Operating Expenses Subcontracts
Fudan EMBSI Cincinnati Children's Travel Equipment Indirect
TOTALS
July - Dec 2006 $ 278,515 $ 400,000 $ 1,311,864 $ 850,989 $ 402,075 $ 58,800 $ 500 $ $ 176,544
$ 2,167,423
Jan - Jun 2007 $ 278,515 $ 250,000 $ 894,935 $ 425,495 $ 407,700 $ 61,740 $ $ $ 137,414
$ 1,560,864
3
SHELL-MCCLURG-058291
Appendix A
Apr 05 Budget Actual Apr 05 Budget Actual Apr 05 Budget Actual Apr 05 Budget Actual Apr 05 Budget Actual Apr 05 Budget Actual
Apr 05 Budget Actual
(J)
I
m
r r
sI :
() ()
r
C
;a
G)
oI c..n ex>
I'V <D I'V
4
Case Accrual
In the 12-month period ending May 1, 2006, there were 977 cases diagnosed at JCML, bringing total case contact to date to 2,313 for which 2,231 diagnoses have been reviewed. Diagnoses have been reviewed and entries verified in the database and strategies are being devised, implemented and tested for the retrieval of study data.
This includes all diseases included in the original case definitions, the expanded disease list that was suggested and approved by the SRP in 2004, nutritional, infectious or reactive diseases as well as other excluded conditions. In addition, we have diagnosed or supported case management of approximately 45 patients for humanitarian reasons that are not included in the case accrual.
Original CC goals for AML and NHL case accrual were predicated on power estimates derived from the ICD-9 classification of diseases but were scaled downward in response to the delay in laboratory start-up and other funding limitations. Case accrual for MDS, AA and BP were originally estimated based on existing diagnostic standards in place in Shanghai at the time the study was designed. Current and projected case accrual numbers are summarized in Table 4. During the last year, case accrual of NHL has increased significantly, exceeding accrual for the first two years of the study combined. However, we will be short of study accrual goals by 13% as of 12/31106. The shortfall for AML case accrual is almost identical to that for NHL.
Table 4. Current and Projected Case Accrual
Study goalsa
Case Accrualb 511/2006
Case Accrualc
(12/31/2006)
Time to Study goalsC
AML: NHL: MDSb: AAb: BPb:
600(500) 600(500)
350 250
50
353 336 379 112
32
424 511/2007
433 511/2007
480 N/A 137 N/A 36 N/A
aOriginal and scaled down ( ) goals based on the ICD-9 classification of diseases.
bCurrent case accrual for AA, MDS and BP reflect the influence of JCML on the frequency of these diseases diagnosed in Shanghai (~. routine use of bone marrow biopsies, application of WHO criteria, discovery of BID). cProjected case accrual based on ICD-9 criteria and current case rate. Numbers for AML, NHL and MDS based on WHO criteria employed in the laboratory are higher, reflecting the expanded disease categories included in the WHO classification that are not included in ICD-9. For example, lymphoid malignancies, including lymphocytic
leukemias, total cases = 520. For AML, differences between ICD9 and WHO include MDS now diagnosed as
leukemias, monocytic leukemias and other subtypes as well as differences in the diagnostic criteria employed (Irons et al (2006) Leukemia Res. 30: 769-775).
5
SH ELL-MCCLU RG-058293
To: BenzConsort-OC@listserve.api.org <BenzConsort-OC@listserve.api.org>;
BenzConsort-TC@listserve.api.org <BenzConsort-TC@listserve.api.org>; BHRC Communications Committee
<benzconsort-cc@ listserve. api. org>
From:
Russell White <whiter@api.org>
Cc:
Bcc:
Received Date:
2006-08-21 11: 12:40 GMT
Subject:
Shanghai Health Study - Case accrual rates
I forgot to include this yesterday - sorry for the extra email.
Jerry Rice put together this table to document the rate of case accrual over the last three years using only WHO criteria. He is asking Dr. Irons to confirm the numbers.
Attachments: SHS Cumulative WHO Case Accrual Figures JR Rev 3.doc
SH ELL-MCCLU RG-058294