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ALLSTAT  July 2009

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Subject:

COURSE: (i) Interim analyses (ii) Equivalence / Non-inferiority Trials, Sydney 12-13 Oct 2009

From:

Mark Chatfield <[log in to unmask]>

Reply-To:

Mark Chatfield <[log in to unmask]>

Date:

Thu, 2 Jul 2009 09:30:05 +1000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (203 lines)

The NHMRC Clinical Trials Centre is pleased to announce...

 

An intermediate/advanced applied course in 

       (i) Methods for interim analysis of controlled studies

      (ii) Equivalence / Non-Inferiority Trials

 

http://www.ctc.usyd.edu.au/education/interim-analysis-equivalence-oct09.
pdf

http://www.ctc.usyd.edu.au/education/interim-analysis-equivalence-regist
ration-oct09.pdf

 

It is an intensive course aimed at biostatisticians and health
professionals with quantitative skills. The course introduces
participants to the methodological and practical issues facing
researchers when designing and analysing interim analyses (i.e.
boundaries and stopping rules) and Equivalence / Non-Inferiority trials.

 

 

- Who should attend?

 

The course is ideally suited for biostatisticians working in clinical
and health research areas. Health professional with strong quantitative
skills may also find this course appropriate. Participants should be
familiar with hypothesis testing, confidence intervals, and sample size
calculations and power. Clinicians with a strong understanding of these
concepts may also find this course of value. 

Due to the nature of this course, only a limited number of people will
be able to participate. We encourage early registrations so that you do
not miss out!

 

 

- Course emphasis

 

The course is designed to discuss both methodology and application of
stopping rules to trials at interim analyses, and in the design and
analysis of Equivalence / Non-Inferiority trials. There is emphasis on
the practical experience of performing analyses with discussion about
advantages and pitfalls for different approaches and the interpretation
of results. The course will be presented at an intermediate/advanced
level.

 

 

- Proposed Topics

 

(i) Interim analyses; formal stopping rules and assessment of evidence

* Stopping rules including O'Brien-Fleming, Haybittle-Peto and Pocock

* Comparison of different approaches

* Alpha-spending methods

* Applications to different outcome measures; continuous, binary and
time to event and regression models

* Stopping for futility - curtailment

 

(ii) Equivalence / Non-inferiority Trials

* Confidence interval approach

* Sample size considerations

* Non-compliance and intention to treat

* Validity and slippage

* Choice of margin

* Closed testing procedures

* Testing for non-inferiority in superiority designs

 

 

- Dates

 

Full Course: Monday 12th - Tuesday 13th October 2009   (2 days)

Methods for interim analyses - Monday 12th October 2009 (1 day)

Equivalence / Non-inferiority - Tuesday 13th October 2009 (1 day)

 

 

- Course fees ($AUD, includes GST)

 

Days 1 & 2:  $1,150* / $1,300

One day only: $770* / $850

    *Early-bird registrations must be received by close-of-business
(5:00pm Sydney) on 28th August.

Full payment must be received by close-of-business (5:00pm Sydney) by
25th September.

Confirmation of registration will only occur with full payment.

Comprehensive notes and relevant software will be supplied.

 

 

- Venue

 

The course will be held at the Citigate Central Sydney Hotel, 169-179
Thomas Street, Haymarket.  This is ideally located in Sydney's CBD, with
ready access to public transport & accommodation.  Excellent restaurants
and cafes are located at nearby Chinatown and Darling Harbour.

Morning tea, Lunch & Afternoon tea provided each day.

 

 

- Laptops

 

Participants should bring their own laptop. User-friendly software will
be provided as part of the course.

Note: If participants are unable to provide their own laptop, please
contact us and we will try to make alternative arrangements.

 

 

- Further Information

 

Tel: +61 2 9562 5000 ask for Kew Flood

E-mail:  [log in to unmask]

NHMRC Clinical Trials Centre 

The University of Sydney

Locked Bag 77

Camperdown NSW 1450

http://www.ctc.usyd.edu.au


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