Document zJrOD5vEdLKXX763gJ0obz7

From: Sent: To: Cc: Subject: Attach: Bruce Jarnot <jarnotb@api.org> Thursday, April 12,20073:21 PM (GMT) Jmricewas@aol.com; BenzConsort-TC@listserve.api.org Russell White <whiter@api.org>; OttoWong@ao1.com; Howard Feldman <Feldman@api.org>; Fitzsimmons, Mark <MFitzsimmons@steptoe.com> SHS ... Rev Timeline & Conf Call reminder wi Dr. Wong - Thurs 12 April, 1:30pm EDT CC study timeline 2007-02-1S.pdf A reminder about today's PI conference call with Dr. Wong, along with a revised timeline (attached file) for discussion on the call: AGENDA Antitrust review (M. Fitzsimmons) Case Control study update (0. Wong) o revised timeline DIAL-IN INFORMATION Day/date: Thursday, April 12 Start time: 1:30PM Eastern / 12:30PM Central / 10:30AM Pacific Phone #: toll-free (866) 443-0059 PIN Code: 202-682-8473-# Best Regards - Bruce. From: OttoWong@aol.com [mailto:OttoWong@aol.com] Sent: Thursday, April 12,2007 11:05 AM To: Bruce Jarnot Cc: Russell White; Jmricewas@aol.com Subject: Re: SHS ... Conf Call wi Dr. Wong - Thurs 12 April, 1:30pm EDT Dear Bruce: Good morning. I would like to discuss the revised timeline for the case-control study later today during our conference call. The revised timeline was attached to our last progress report dated 15 February 2007. For convenience, I have attached it to this email. I would appreciate it very much if you could send it out to all conference call participants before the call. Many thanks, Otto ******** Otto Wong, ScD., 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, USA Adjunct Professor of Community Medicine, Chinese University of Hong Kong Honorary Professor of Community Medicine, University of Hong Kong SHELL-MCCLURG-053714 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 ************************************** See what's free at http://www.aal.eam. SHELL-MCCLURG-053715 Timeline for the Case-control Study (from Applied Health Sciences progress report dated 15 February 2007) The current understanding is that patient accrual will be extended to the end of 2007. Given the new end date for case accrual, final diagnoses, control selection, and interviews will most likely be completed around the end of the first quarter of 2008. Exposure assessment of newly enrolled patients (cases and controls) will be conducted in the first and second quarters of 2008. Assuming that both diagnostic and exposure data for all patients will be finalized and available by June 2008, Applied Health Sciences (AHS) will be performing epidemiologic analyses of the final data in the third quarter of 2008. To facilitate data transfer/linkage and to develop plans for statistical analyses, however, AHS needs large and representative samples of study subjects with all questionnaire information, exposure estimates, and final diagnoses by mid-2007 (see the timeline table below). These samples will have sufficient details to allow AHS to develop plans for data QNQC, data transfer/linkage and to test-run analysis programs. 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 AHS. 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 the current understanding and assumptions above. RceV.lsedt'ImerIne 0fthe case-controi ts udlY Tasks Date Test data sets to AHS* June 2007 QNQC of test data sets July-September 2007 Development of analytical programs/plans October 2007-March 2008 End of patient accrual* December 2007 Final diagnoses of all patients completed* March 2008 Interviews of all patients completed* March/April 2008 Questionnaire data entry completed* May 2008 Exposure assessment completed* June 2008 Final QNQC and data editing July-August 2008 Complete final data to AHS* End of June 2008 Statistical/epidemiological analysis August-September 2008 Preparation of draft report September-October 2008 Presentation of study results October 2008 Discussion with SRP October-November 2008 Preparation of final report October-December 2008 * Activities not under the control of AHS. SHELL-MCCLURG-053716