Document jJnQn5gqnEQ6rpmqqexMDBZQ

To: Clegg, Patsy M SCC-DCS/22 <patsy.clegg@shell.com>; Tsai, Shan P SHLOIL-SHS <Shan.Tsai@shell.com> From: Cagen, Stuart Z SHLOIL-SHOIL-SHS </O=SHE LUOU=MSXSCC/CN=RE CI PI ENTS/CN=SC724012> Cc: Bcc: Received Date: 2006-12-0814:28:20 GMT Subject: FW: SHS. please revise I resubmit the newest AHS budget Stuart Cagen, Ph.D. Senior Toxicologist Shell Health Services One Shell Plaza 910 Louisiana Street Houston, Texas 77002 Telephone: 1-713-241-1407 Fax: 1-713-241-3325 Mobile: 1-832-646-3987 email: stuart.cagen@shell.com -----Original Message----From: OttoWong@aol.com [mailto:OttoWong@aol.com] Sent: Friday, December 08, 20062:07 AM To: jarnotb@api.org Cc: whiter@api.org; Cagen, Stuart Z SHLOIL-SHOIL-SHS Subject: Re: SHS. please revise I resubmit the newest AHS budget Dear Bruce: After talking to you about the increased airfares to Shanghai, I looked up the airfares on United Airline's website again. On the average, I underestimated my estimate for airfares in my previous budget proposal by about $1,500 per trip. I have revised my budget proposal accordingly (attached, dated 2006-12-8). Although the total increase ($11 ,418) over the previously estimated budget is relatively minor, I agree with your advice that it is far better to request an adequate budget upfront than to ask for supplemental funds later. In my revised cover letter (attached, dated 2006-12-8), I have added a couple of sentences (in the second paragraph) emphasizing the importance of an adequate study sample size. Specifically, I added the following sentences. "An adequate sample size of both AML and NHL cases is important for analyses stratified by exposure level, occupation/industry, diagnostic subtype, etc. Recent studies suggest that different subtypes of AML and NHL are associated with different risk factors." Please make sure that the sponsors understand this point. If you have any questions or need additional information, please let me know. Regards, Otto ******** Otto Wong, Sc.D., FAC.E. SHELL-MCCLURG-062818 Fellow. American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of Northern Texas, Fort Worth, USA Adjunct Professor of Epidemiology, Tulane University, New Orleans, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong Visiting Professor of Occupational Epidemiology, Fudan University, Shanghai Associate Editor, Annals of Epidemiology Editorial Board, Regulatory Toxicology and Pharmacology Tel: 1 (650) 347-7898 Fax: 1 (650) 344-6887 Email: OttoWong@aol.com --- Original message --Subj: Shanghai Health Study... please revise 1 resubmit the newest AHS budget Date: 12/4/20069:27: 11 AM Pacific Standard Time From: jarnotb@api.org To: OttoWong@aol.com CC: whiter@api.org Sent from the Internet (Details) Dear OttoRepeating my rambling voicemail message... 1) At your earliest convenience, please revise and resubmit the most recent AHS budget, which you developed in response to the revised NHL case collection timeline; 2) Also, I would like to pick your brain for potential metrics of study progress that can be easily checked on a regular (monthly?) basis, and that will - in total - provide reasonable assurance that "all systems are go" Best Regards - Bruce (202/682-8473) Attachments: Letter to Bruce Jarnot 2006-12-8.ZIP SHELL-MCCLURG-062819 Applied Health Sciences, Inc. 181 Second Avenue, Suite 628 Post Office Box 2078 San Mateo, California 94401 USA Otto Wong, SeD. Fellow of American College of Epidemiology Associate Editor ofAnnals ofEpidemiology Adjunct Professor of Epidemiology University of Northern Texas, Fort Worth, USA Adjunct Professor of Epidemiology Tulane University Medical Center, New Orleans, USA Adjunct Professor of Community & Family Medicine Chinese University of Hong Kong, Hong Kong, China Honorary Professor of Community Medicine University of Hong Kong, Hong Kong, China Visiting Professor of Occupational Epidemiology Fudan University Medical Center, Shanghai, China Editorial Board, Regulatory Toxicology & Pharmacology Telephone: 1 (650) 347-7898 Facsimile: 1 (650) 344-6887 Email: OttoWong@aol.com December 8, 2006 Bruce M. Jarnot, Ph.D., DABT Senior Toxicologist Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street, NW Washington, DC 20005 Re: Revised timeline and additional budget for case-control study for 2007 & 2008 Dear Bruce: I am writing to follow-up my recent discussions with both you and Dr. Stuart Cagen regarding our request for revising both the timeline and budget estimate for the case-control study of AML and NHL. As reported at the August meeting in Houston, the number of patients in the case-control study will not reach the target sample of 500 by December 2006, the original end date for case accrual. An adequate sample size of both AML and NHL cases is important for analyses stratified by exposure level, occupation/industry, diagnostic subtype, etc. Recent studies suggest that different subtypes of AML or NHL are associated with different risk factors. To reach the target sample size, it becomes necessary to extend case accrual into 2007. As a result, both the timeline and the budget for the case-control study will be significantly affected, and both need to be revised. I have been asked, for the purpose of projecting a new timeline and estimating additional budget for the case-control study, to assume that case accrual will end by December 2007. As you well know, the timeline of the case-control study depends heavily on the timing when diagnostic and exposure data (both test data samples and final complete data sets) are provided to us. The delay of anyone event in the timeline will likely affect the others. The revised timeline below for the case-control study is based on our current understanding and assumptions. SH ELL-MCCLU RG-062820 Tasks Test data sets to AHS* QA/QC of test data sets Development of analytical programs/plans End of patient accrual* Final diagnoses of all patients completed* Interviews of all patients completed* Questionnaire data entry completed* Exposure assessment completed* Final QA/QC and data editing Statistical!epidemiological analysis Preparation of draft report Presentation of study results Discussion with SRP Preparation of final report *activities not under our control. Date June 2007 July-September 2007 October 2007-March 2008 December 2007 March 2008 March/April 2008 May 2008 June 2008 July-August 2008 August-September 2008 September-October 2008 October 2008 October-November 2008 October-December 2008 As indicated in the timeline above, some of our most important tasks can be carried out in 2008 only after patient accrual has been completed, diagnoses have been finalized and exposure classifications have been assigned. We will begin analysis and draft report preparation in the third quarter of 2008. At this moment, there is no budget for the case-control study at all for 2008. (Please refer to the contract amendment signed between American Petroleum Institute and Applied Health Sciences in November 2006, Contract No. 2004-101153, Amendment No. 1.) Obviously, we need additional funds to complete the case-control study. Based on the newly estimated timeline above, I have prepared an additional budget that will allow us to complete the case-control study by the end of 2008. The additional budget (dated 2006/12-8) is attached. Additional amounts by year (2007 and 2008) are itemized and justified in the attached budget. We are requesting the following additional amounts by year: Year 2007 Year 2008 Total $157,395 $640,883 $798,278 These amounts are needed in addition to those already approved in the November 2006 amendment (Contract No. 2004-101153, Amendment No. 1.). If you have questions, please let me know. Otto Wong, Sc.D. Chief Epidemiologist Enclosure: AHS additional budget for 2007 & 2008 cc: Dr. Stuart Cagen 2 SHELL-MCCLURG-062821