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.

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OVERVIEW

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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.

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BASUG QUARTERLY MEETING (MORNING EVENT)

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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

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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.

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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.

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CLEANING CLINICAL DATA TRAINING SESSION (AFTERNOON EVENT)

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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

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BASUG INFORMATION

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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

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