Document mmjyLKyMwY5enONXkyBYoqObQ

To: From: Cc: Bcc: Received Date: Subject: Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> ottowong@aol.com <ottowong@aol.com> whiter@api.org <whiter@api.org> 2007-04-2806:40:36 GMT Fwd: Shanghai Health Study - DRAFT deliverables Dear Stuart: I got your email to Rich Irons and me. As we discussed on the phone the other day, I need to know whether Rich Irons has been been sent the "deliverables" by Russ White. Russ White sent me the draft deliverables several weeks ago and asked me to go over them. I did and made some suggested changes (attached). Russ has not sent me the final version. I don't what has been sent to Rich Irons and I would like to know the final version sent to him. I would like to use the deliverables as the basis for discussion with Rich Irons. Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: ottowong@aol.com To: whiter@api.org; jarnotb@api.org Cc: Jmricewas@aol.com Sent: Mon, 16 Apr 2007 9:03 AM Subject: Re: Shanghai Health Study - DRAFT deliverables Dear Russ and Bruce: I have made some suggested changes to the "deliverables" that are specific to the case-control study (attached). I would be very grateful if you could incorporate them into the final version. If you would like to discuss these changes, please let me know. I am in town all week. As I emphasized during our conference call last week, I still need the local support from the research assistants who work under Professor Fu at the Fudan School of Public Health. Fu has a very small independent contract with API for that. I would like to see his contract renewed (at the same level) so that there will be no disruption in my work. If API does not intend to renew his contract, please let me know and I need to look for another independent group in Shanghai to help me (I do not prefer this because there will be a learning curve.). SH ELL-MCCLU RG-054935 Regards. Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: OttoWong@aol.com ; Jmricewas@aol.com ; BenzConsort-TC@listserve.api.org Sent: Thu, 12 Apr 2007 1:54 PM Subject: Shanghai Health Study - DRAFT deliverables Based on the call today, I have modified the potential deliverables from Cinpathogen. Please send me any comments you have. Otto - I have also attached the enrollment criteria for the case-control study, both the original text and the recent version from Cinpathogen. Let me know if you have any suggested changes in the Cinpathogen protocol. (FYI Figure 8.1 was not included in the document we received from Cinpathogen. While Dr. Iron's said it was in the original version, I could not find it.) >> Russell White Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070 Tel: 202-682-8344 Fax: 202-682-8270 AOL now offers free email to everyone. Find out more about what's free from AOLat AOL.com. Attachments: DRAFTModifiedDeliverables from WONG 2007-04-16.doc SH ELL-MCCLU RG-OS4936 DRAFT Modified Deliverables (with suggested changes from Otto Wong, 2007~04~16) Case Control Study Cases diagnosed prior to December 31,2007 of hematopoietic and lymphoid neoplasms (WHO, 2001) and a individually matched (2x) sets of controls selected randomly from the entire patient populations at the participating hospitals in Shanghai that will include: Case selection following criteria ("eligibility") in Cinpathogen's March 18, 2007 DPME proposal, Section 8.1 Documented informed consents and work history questionnaire administration for all cases and controls Verified diagnoses of approximately 500 - 600 cases of AML Cases of NHL (i,e" lymphoid neoplasms) will be accrued until December 31,2007 ~ An account of all eligible AML and NHL patients at all participating hospitals, who did not agree to participate or who were not interviewed, includin~J their basic demographic information and reasons for non~participation!non~interview (if available) will be provided, [Note: This information is vital in assessing whether there is any selection bias bet\,",,'een participating and non-paliicipating, but otherwise eligible, AML and NHL patients.] A benzene job-exposure assessment matrix (JEM) for all study cases and controls for use in the case-control protocol. The matrix will consider task, job, industry and time period in developing exposure estimates to benzene. Data sources for exposure assessment including the IPHS data set, Yang Pu database, the Chinese literature, real-time monitoring in selected factories and simulations will be used to arrive at credible benzene exposure estimates. SUPPcl!iing and other relevant documents of the JEM will also be provided, A suDstanti-al..pr-eliminar-y test data set (tnefl:lding consisting of all available AMLs and NHLs diagnosed by WHO and ICD-9 criteria and their matched controls), including detailed subtype diagnostic classifications, confounders and job~ exposure assessment matrix, and all questionnaire information (such as medical histories, family histories, lifestyle information, etc,) for testing the case-control protocol and for developing analytical programs to Applied Health Sciences by mid-September 2007*. A final data set (inoluding consisting of all AMLs and NHLs diagnosed by WHO and ICD-9 criteria and their matched controls), including detailed subtype diagnostic classifications, confounders and job-exposure assessment matrix, and all questionnaire information (such as medical histories, family histories, lifestyle information, etc,) for completion of the case-control protocol to Applied Health Sciences by July 1, 2008*. SH ELL-MCCLU RG-OS4937 *8ased on a timeline agreed upon in cooperation with the independent QA/QC team and Dr. Otto Wong of Applied Health Sciences SH ELL-MCCLU RG-OS4938 To: From: Cc: Bcc: Received Date: Subject: whiter@api.org <whiter@api.org> ottowong@aol.com <ottowong@aol.com> Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> 2007-04-2814:43:33 GMT Re: Shanghai Health Study - DRAFT deliverables Dear Russ: Thank you for the quick response (working on Saturday morning!). I think we should wait and see how Rich Irons reacts to the final deliverables. Hopefully, he will be able to meet most of them and there will be no major issues going forward with the new scheduleitimeline. When I talked with Rob Schnatter on Thursday, he did not think the deliverables were unreasonable. I also talked with Tom Arstrong last week as well, and he is willing to give me at least some preliminary exposure estimates in the test data sets as soon as possible. All it takes is Rich Irons' approval. Certainly I will not insist on something that's unreasonable or infeasible. I simply want to know what will be available to me by when, so that I can realistically plan the timeline of completing the case-controls study. Thanks your help. Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: ottowong@aol.com; stuart.cagen@shell.com Sent: Sat, 28 Apr 20074:34 AM Subject: RE: Shanghai Health Study - DRAFT deliverables Otto, While Rich Irons has seen the "draft" deliverables, the final version should be available this Tuesday. I'll make sure you and Rich get a copy. From: ottowong@aol.com [ mailto:ottowong@aol.com] Sent: Saturday, April 28, 2007 2:40 AM SH ELL-MCCLU RG-OS4939 To: stuart.cagen@shell.com Cc: Russell White Subject: Fwd: Shanghai Health Study - DRAFT deliverables Dear Stuart: I got your email to Rich Irons and me. As we discussed on the phone the other day, I need to know whether Rich Irons has been been sent the "deliverables" by Russ White. Russ White sent me the draft deliverables several weeks ago and asked me to go over them. I did and made some suggested changes (attached). Russ has not sent me the final version. I don't what has been sent to Rich Irons and I would like to know the final version sent to him. I would like to use the deliverables as the basis for discussion with Rich Irons. Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: ottowong@aol.com To: whiter@api.org ; jarnotb@api.org Cc: Jmricewas@aol.com Sent: Mon, 16 Apr 2007 9:03 AM Subject: Re: Shanghai Health Study - DRAFT deliverables Dear Russ and Bruce: I have made some suggested changes to the "deliverables" that are specific to the case-control study (attached). I would be very grateful if you could incorporate them into the final version. If you would like to discuss these changes, please let me know. I am in town all week. As I emphasized during our conference call last week, I still need the local support from the research assistants who work under Professor Fu at the Fudan School of Public Health. Fu has a very small independent contract with API for that. I would like to see his contract renewed (at the same level) so that there will be no disruption in my work. If API does not intend to renew his contract, please let me know and I need to look for another independent group in Shanghai to help me (I do not prefer this because there will be a learning curve.). Regards, Otto SH ELL-MCCLU RG-054940 ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: OttoWong@aol.com; Jmricewas@aol.com; BenzConsort-TC@listserve.api.org Sent: Thu, 12 Apr 2007 1:54 PM Subject: Shanghai Health Study - DRAFT deliverables Based on the call today, I have modified the potential deliverables from Cinpathogen. Please send me any comments you have. Otto - I have also attached the enrollment criteria for the case-control study, both the original text and the recent version from Cinpathogen. Let me know if you have any suggested changes in the Cinpathogen protocol. (FYI Figure 8.1 was not included in the document we received from Cinpathogen. While Dr. Iron's said it was in the original version, I could not find it.) >> Russell White Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070 Tel: 202-682-8344 Fax: 202-682-8270 AOL now offers free email to everyone. Find out more about what's free from AOLat AOL.com. SH ELL-MCCLU RG-OS4941 To: From: Cc: Bcc: Received Date: Subject: whiter@api.org <whiter@api.org> ottowong@aol.com <ottowong@aol.com> Cagen, Stuart Z SHLOIL-SHOIL-SHS <stuart.cagen@shell.com> 2007-05-0414:47:14 GMT Re: Shanghai Health Study - DRAFT deliverables Russ: Thank you for the update. I will contact Rich Irons regarding the deliverables for the case-control study after he has looked at them. Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: ottowong@aol.com Cc: stuart.cagen@shell.com Sent: Fri, 4 May 2007 6:21 AM Subject: RE: Shanghai Health Study - DRAFT deliverables Otto, Sorry for the delay. There were comments from company members that forced a second draft to be circulated. The final document should be done on Monday (May 7). From: ottowong@aol.com [mailto:ottowong@aol.com Sent: Thursday, May 03, 2007 10:58 AM To: Russell White Cc: stuart.cagen@shell.com Subject: Re: Shanghai Health Study - DRAFT deliverables Dear Russ: Just to follow up your email last week, have you sent out the revised version of the deliverables to Rich Irons? I would like to see a copy as well. SH ELL-MCCLU RG-OS4942 Many thanks, Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: ottowong@aol.com ; stuart.cagen@shell.com Sent: Sat, 28 Apr 20074:34 AM Subject: RE: Shanghai Health Study - DRAFT deliverables Otto, While Rich Irons has seen the "draft" deliverables, the final version should be available this Tuesday. I'll make sure you and Rich get a copy. From: ottowong@aol.com [mailto:ottowong@aol.com] Sent: Saturday, April 28, 2007 2:40 AM To: stuart.cagen@shell.com Cc: Russell White Subject: Fwd: Shanghai Health Study - DRAFT deliverables Dear Stuart: I got your email to Rich Irons and me. As we discussed on the phone the other day, I need to know whether Rich Irons has been been sent the "deliverables" by Russ White. Russ White sent me the draft deliverables several weeks ago and asked me to go over them. I did and made some suggested changes (attached). Russ has not sent me the final version. I don't what has been sent to Rich Irons and I would like to know the final version sent to him. I would like to use the deliverables as the basis for discussion with Rich Irons. Otto ******** Otto Wong, Sc.D., FAC.E. SH ELL-MCCLU RG-054943 Fellow. American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: ottowong@aol.com To: whiter@api.org; jarnotb@api.org Cc: Jmricewas@aol.com Sent: Mon, 16 Apr 2007 9:03 AM Subject: Re: Shanghai Health Study - DRAFT deliverables Dear Russ and Bruce: I have made some suggested changes to the "deliverables" that are specific to the case-control study (attached). I would be very grateful if you could incorporate them into the final version. If you would like to discuss these changes, please let me know. I am in town all week. As I emphasized during our conference call last week, I still need the local support from the research assistants who work under Professor Fu at the Fudan School of Public Health. Fu has a very small independent contract with API for that. I would like to see his contract renewed (at the same level) so that there will be no disruption in my work. If API does not intend to renew his contract, please let me know and I need to look for another independent group in Shanghai to help me (I do not prefer this because there will be a learning curve.). Regards, Otto ******** Otto Wong, Sc.D., FAC.E. Fellow, American College of Epidemiology Chief Epidemiologist, Applied Health Sciences, San Mateo, California, USA Adjunct Professor of Epidemiology, University of North Texas, Fort Worth, Texas, 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----From: whiter@api.org To: OttoWong@aol.com; Jmricewas@aol.com; BenzConsort-TC@listserve.api.org SH ELL-MCCLU RG-OS4944 Sent: Thu, 12 Apr 2007 1:54 PM Subject: Shanghai Health Study - DRAFT deliverables Based on the call today, I have modified the potential deliverables from Cinpathogen. Please send me any comments you have. Otto - I have also attached the enrollment criteria for the case-control study, both the original text and the recent version from Cinpathogen. Let me know if you have any suggested changes in the Cinpathogen protocol. (FYI Figure 8.1 was not included in the document we received from Cinpathogen. While Dr. Iron's said it was in the original version, I could not find it.) >> Russell White Regulatory and Scientific Affairs American Petroleum Institute 1220 L Street NW Washington, DC 20005-4070 Tel: 202-682-8344 Fax: 202-682-8270 AOL now offers free email to everyone. Find out more about what's free from AOLat AOL.com. SH ELL-MCCLU RG-054945