Shanghai Biostatistics Forum (SBF) 2nd Event 2013 | May 17, 2013|SMMU

Shanghai Biostatistics Forum (SBF) 2nd Event 2013 | May 17, 2013 Friday, 9:30-5:30pm | Second Military Medical University (SMMU)

- T# S: T9 Y! y! b, EDate and Time:  Friday, May 17, 2013, 9:30am-12:00pm, 13:30pm-5:30pm

% ]9 n2 U7 I4 C! W: Q4 J: `" z/ JLocation:  Conference Room No.3, Jin Xue Yuan Hotel, 631 Xiangyin Rd. Shanghai
( Y0 ~& g# }, z+ V0 l锦雪苑第三会议室，翔殷路631号，上海（详细地址见下）

Attendee:Open to everyone who is interested.

Theme: Full-day short course on non-inferiority, equivalence and similarity clinical trials. (See    below for details)
, W( o" {& a$ Z$ |; \4 L; E) J  rAgenda:
5 @3 m9 }2 Z# ]3 @: }0 K; i4 lIntroduction and Welcome Remarks
　　　DIA China Representative and Dr. Irving Hwang
Full-day short course:   Non-inferiority, equivalence and similarity clinical trials – the statistical foundations
Instructor: Dr. Tsong Yi (Deputy Director of Division of Biometrics VI, Office of Biostatistics, OTS, CDER, FDA)

About The Speaker
$ R, o3 z9 `' n' v+ ~, ~Dr Tsong is Division Deputy Director at US FDA and is a well known statistician in the regulatory and drug development field. He has a long list of achievements/honors including serving as an associate editor of statistical journals such as Statistic in Medicine and Journal of biopharmaceutical Statistics.
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4 ~" M5 Z2 A8 K" t5 `- ~! TAbstract (next page)
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9 \7 R" D+ _0 ~+ Y& ~4 {Non-inferiority, equivalence and similarity clinical trials – the statistical foundations

6 `/ Q7 n( c  V, {4 c# DYi Tsong, Ph.D.,
" g, L) b. X  }' w0 cDeputy Director of Division of Biometrics VI, Office of Biostatistics, OTS, CDER, FDA
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3 n: Q; n* c( j' e" I8 j5 k* HActive control treatment has often been used as a benchmark to assess the efficacy of the test treatment, or the equivalence and similarity to the test treatment. The objective of non-inferiority is to test if the mean efficacy response of test treatment is not smaller than the control treatment by a pre-determined non-inferiority margin - δ or the ratio to the test treatment is no larger than a pre-determined non-inferiority margin λ, in order to demonstrate non-inferiority. The objective of the equivalence or similarity trial, is to test if the difference or ratio of the mean responses of the test and control treatments is within an equivalence/similarity margin δ in order to demonstrate equivalence or similarity of the two treatment. On the other hand, the objective of an individual equivalence or exchangeability trial is to demonstrate that the test and control treatment have the same effect in the subject that the subject may switch between the treatment without any impact on the efficacy response.
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In this short course, we will discuss the differences between the various applications of the non-inferiority, equivalence, similarity and exchangeabilities. We will introduce the statistical foundations of trials including the hypotheses, designs and analyses involved. Since multiple comparisons are required in the equivalence, similarity and exchangeability trials, the sample size adjustment will also be discussed. Some of the specific applications of the approaches will also be introduced.  
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3 J1 Z4 b$ q* M9 M' qWeb site and mailing list announcement:
Dr. Zibao Zhang, PPD Inc

Local coordinators and contacts:
9 V( Z0 T  S8 |8 ^2 A% QLocal coordinators from SMMU: Professor Jia He and Dr Rui Wang
# D, {- ^7 ?0 A9 V! r! P( C( G  VAddress: Room 601, Military Medical Building, No.800 Xiangyin Road, Shanghai
Tel: 021－81871441, 81871443－8003
# z9 [# h0 H# F" M, D/ V3 }承办单位：DIA China and SBF

/ U, {8 b. {1 c/ ALocation: Conference No.3, Jin Xue Yuan Hotel, 631 Xiangyin Road, Shanghai
会议地点：上海市翔殷路631号锦雪苑第三会议室
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Direction:By Metro Line 8 to Xiangyin Road  station, Exit 2.  
交通：地铁8号线翔殷路站2号出口即是
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# \. k  n; U: CA registry system(use the link as below) is now ready which is expected to help us to get some idea of the number of attendees before we arrange a meeting room with enough capacity. http://126.am/SBF2Q2013
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If you are interested in this event, you may need to leave some basic information, like name, email address, etc.

/ f: F- u+ f, ]6 z8 S. mThe Event Registry will be closed on May 15, 2013(Wednesday)! PLEASE complete the registration in a timely manner!
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I will also be very happy if you could suggest anything on this registration.
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