To: Sent by: Subject: Basug Quarterly Meeting and Training Sent by: basugwm@basug.org 05/12/2004 10:11 AM PLEASE NOTE: This announcement contains information on TWO separate events happening on the same day. In the morning we will have a BASUG Quarterly Meeting. In the afternoon, we are holding a half-day training session (additional fee required). Come to just one, or both. Separate registration is required for the 2 events. *==================================================================== OVERVIEW *==================================================================== WHAT: Quarterly BASUG Meeting AND Cleaning Clinical Data Training Session THEME: Statistics and Clinical Data WHEN: Tuesday, June 29, 2004 Quarterly Meeting: 8:00AM - 12:00PM Training Session: 1:15PM - 5:00PM WHERE: Holiday Inn Newton (Directions are included below.) 399 Grove Street Newton, MA 02462 (617-969-5300) INDIVIDUAL, ON-LINE REGISTRATION REQUIRED for both events. NO EMAIL. Please do not reply to this message. To register for the morning meeting, visit http://www.basug.org/register.php3 CONTACT for the morning meeting: Peter Gaccione: gaccione@hcp.med.harvard.edu To register for the afternoon training session, visit http://www.basug.org/register.php3 CONTACTS for the afternoon training: Bridget Neville: bridget_neville@dfci.harvard.edu or Karen Olson: karen.olson@childrens.harvard.edu An email will be sent to confirm all online registrations. If you are also registering for the afternoon Training Session, the confirmation will include additional information about how to pay. *====================================================================* BASUG QUARTERLY MEETING (MORNING EVENT) *====================================================================* LEVEL: This meeting is appropriate for beginning to advanced programmers A basic to intermediate statistical background would be helpful but is not required. Note that there is a focus on power and sample size calculations. There is no fee for this meeting but you are encouraged to have your membership dues paid. Check the BASUG webpage, www.basug.org, for details. AGENDA: 8:00 - 8:30 Sign in and Coffee Break 8:30 - 8:45 Meeting Announcements and Introductions 8:45 ? 12:00 Speakers /******************************************************************/ 8:45 to 9:15 "SAMPLE SIZE RE-ESTIMATION WITHOUT UNBLINDING THE STUDY" Fanny O'Brien, PhD Abstract: Sometimes an interim analyses is planned for a clinical trial in order to re-estimate the sample size using information gathered at the beginning of the study. In particular, a more accurate idea of the standard deviation of the outcome variable would be available. This talk discusses re-estimation of the sample size without unblinding the study. It is an adaptation of an EM algorithm method based on a paper by Gould and Shih (1992). Gould's and Shih's methodology for normally distributed outcomes with unknown variance is based on two treatment groups. This talk is a modification of their original paper to revise the algorithm for three treatment groups and its subsequent application to a recently completed clinical trial. Bio: Fanny O'Brien is Associate Director of Biometrics for Serono, Inc., in Rockland, MA. /******************************************************************/ 9:15 to 9:45 "ESTIMATION OF INCIDENCE RATE" Peter Chang, PhD Abstract: Exact and approximation method for estimation of one population will be presented. In addition, the point and interval estimate of the ratio of the two populations will be presented. The corresponding SAS procedure will be demonstrated. Bio: Peter Chang is Associate Director of Biometrics for Serono, Inc., in Rockland, MA. /******************************************************************/ 10:00 to 12:00 3. "Power and Sample Size Computations Using SAS Software" Instructor: John Castelloe, SAS Institute Power determination and sample size computations are an important aspect of study planning and help produce studies with useful results for minimum resources. This statistical seminar reviews basic methodology for power and sample size computations for a number of analyses including proportion tests, t tests, confidence intervals, equivalence tests, survival analyses, correlation, regression, ANOVA, and more complex linear models. The seminar illustrates these methods with numerous examples using new SAS software: the POWER and GLMPOWER procedures and the PSS web interface. The seminar details how to use the software to compute power and sample size, perform sensitivity analyses for other factors such as variability and type I error rate, and produce customized tables, graphs, and narratives. This tutorial was given at SUGI 29 in Montreal. Some basic understanding of power and sample size computations is assumed. *====================================================================* CLEANING CLINICAL DATA TRAINING SESSION (AFTERNOON EVENT) *====================================================================* COURSE: Cleaning Clinical Data INSTRUCTOR: Bob Virgile PRICE: $ 75 early registration by June 15th $100 late/on-site registration (available to BASUG members with paid dues for 2004) PRE-REQUISITES: This is an intermediate level SAS course. It begins with simpler concepts (what is an edit check, how do edit checks relate to the larger process of submitting a new drug application), and progresses to cover the programming techniques needed to clean clinical data. To fully comprehend a couple of more advanced topics, it would be helpful to be familiar with proc format (including cntlin= and cntlout= data sets), the basics of macro language, and the out= option of proc contents. INTENDED AUDIENCE: SAS programmers who work with clinical data. COURSE OUTLINE: Cleaning clinical data goes a lot further than running Proc Freq. For example, programs can check ranges of valid values, consistency over time, and proper sequencing of dates. Programs can compare one data set to another to verify such items as completeness of the data and assignment of medical events to the proper patient. This course examines various types of data checks and the programming techniques needed to perform those checks on clinical data. BIO: Bob Virgile is a SAS veteran, with over 20 years of experience developing and teaching SAS classes, including 6 years in the pharmaceutical industry. He is a regular presenter at SUGI, BASUG, and regional conferences, and formerly composed the problem-solving contests for SUGI and NESUG. He has written two books for SAS Institute, and is currently barred from participating in the NESUG SAS Bowl due to superior SAS knowledge. DIRECTIONS FOR BOTH EVENTS Holiday Inn Newton 399 Grove Street Newton, MA 02462 (617-969-5300) DRIVING: FROM BOSTON: Take I-90 West to Exit 15, then take Route 128 South (I-95)1/4 mile to Exit 22. When you exit, stay right and bear right at the fork onto Grove Street. The hotel is on your left. FROM SOUTH OF BOSTON: Take Route 128 North (I-95) to Exit 22. When you exit, stay right and bear right at the fork onto Grove Street. The hotel is on your left. FROM WESTERN MASS: Take I-90 East to Exit 14, then take Route 128 South (I-95) 1/4 mile to Exit 22. When you exit, stay right and bear right at the fork onto Grove Street. The hotel is on your left. FROM NEW HAMPSHIRE: Take I-93 South to Route 128 South (I-95), follow for approximately 15 miles to Exit 22. When you exit, stay right and bear right at the fork onto Grove Street. The hotel is on your left. FROM RHODE ISLAND: Take I-95 North to Route 128 North (I-95). Follow to Exit 22. When you exit, stay right and bear right at the fork onto Grove Street. The hotel is on your left. PUBLIC TRANSPORTATION: The hotel is adjacent to the Riverside T Station. From Kenmore Square take the Green Line - D (Riverside) to the Riverside stop. The hotel is adjacent to the T Station. The hotel is also accessible from downtown Boston via Express Bus #500 (EXPRESS BUS Riverside - Downtown via Mass. Turnpike). The bus drops off at Riverside T Station, which is adjacent to the hotel. For a detailed bus route and schedule, go to http://www.mbta.com/schedmaps/bus/index.cfm *==================================================================== BASUG INFORMATION *==================================================================== MAILING ADDRESS: BASUG PO Box 253 Boston, MA 02117 WEBMASTER: webmaster@basug.org MEMBERSHIP: If would would like to join BASUG or need to pay dues for the 2004 calendar year, please print this membership form and follow the instructions on the form: http://www.basug.org/MemForm2004.doc (If you are registering for the training AND need to pay dues, the payments can be combined. Please register for the training, then see your confirmation letter for payment mailing instructions.) If you are unsure if you are a member or you do not know if your company has paid its 2004 calendar year corporate dues, please contact Vanessa Hayden: vchayden@yahoo.com -- or -- Robert Rosofsky: robert.rosofsky@verizon.net SUBSCRIBE TO OUR EMAIL LIST: Subscribers receive automatic e-mail notification of upcoming meetings, courses, and conferences of interest to local SAS users. To subscribe to the BASUG message list, send a message to majordomo@basug.org, and in the BODY of the message specify: subscribe basugnews To unsubscribe to the BASUG message list, send a message to majordomo@basug.org, and in the BODY of the message specify: unsubscribe basugnews