> Dear Allstat
> A PSI TRAINING COURSE ON DATA MONITORING COMMITTEES BY MARY FOULKES &
> SIMON DAY - 10 & 11 MARCH 2009
> This is a reminder that we have places available on the 2-day training
> course " Data Monitoring Committees" on 10th & 11th March 2009,
> presented by Mary Foulkes & Simon Day at Denham Grove, Tilehouse Lane,
> Denham, Buckinghamshire, UB9 5DU.
> To guarantee your accommodation for the course please book before 6th
> January 2009. All accommodation requests made after this date cannot
> be guaranteed.
> This course will focus on practical issues around the workings of data
> monitoring committees. It is relevant to all those who need to set up
> DMCs and work with them throughout the course of a trial or of a full
> development programme. The following key topics will be addressed:
> * Formal interim analyses, 'administrative' interim analyses,
> safety monitoring
> * Arguments for and against stopping trials early (scientific
> issues, ethical, regulatory)
> Regulatory guidance
> * CHMP and FDA
> * Other guidance (e.g. WHO, NIH)
> * Interaction with regulators; what regulators might and might not
> do (and when)
> Overview of group sequential methods
> * Stopping 'rules'
> * Haybittle and Peto, Pocock, O'Brien and Fleming, alpha-spending
> * Bayesian methods
> How do DMC meetings run?
> * Frequency, location, structure, attendance
> * Conduct and communication
> * Practical problems (dissemination of information (including
> minutes), independence, communications)
> Register online at www.psiweb.org and click onto Events to confirm
> your place. To receive your earlybird discount, register by 2nd
> February 2009. Payment is now available online.
> For those unfamiliar with the location, the hotel is easily accessible
> by train and car, and from airports. Please find details below
> By Car
> From the South and M4, head north to Junction 16 on the M25 then join
> the M40 eastbound. Proceed to Junction 1 and follow the A40 (Gerrards
> Cross) then turn right onto the A412 at the traffic lights. Turn into
> Tilehouse Lane (second left). Continue for about 1 & 3/4 miles. Denham
> Grove is on the right.
> From the North and M1, follow the M25 to Junction 17. Join the A412
> southbound. Continue for about 3 & 1/2 miles then turn right into
> Denham Green Lane. When you reach the T junction turn right into
> Tilehouse Lane. Continue for about 1/2 of a mile. Denham Grove is on
> the right.
> By Train
> Trains run from Marylebone to Denham station. Piccadilly or
> Metropolitan lines run to Uxbridge or Rickmansworth
> By Air
> Heathrow (15 miles) and Gatwick (60 miles) are within easy reach.
> Website Address:
> We look forward to receiving your registrations.
> Kind regards
> PSI Executive Office
> PSI Events Co-ordinator
> Tel: +44 (0)1625 267882 Fax: +44 (0)1625 267879
> Resources for Associations Ltd
> Registered Office: South Park Road, Macclesfield, SK11 6SH
> Registered in England No. 4391074
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