Data Monitoring Committees & Interim Analyses in Clinical Trials

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The APBG and SSAI are pleased to present the following workshop:

Data Monitoring Committees & Interim Analyses in Clinical Trials
held at MGSM CBD Executive Conference Centre, Sydney

A workshop with Dr Simon Day, Director of Clinical Trials Consulting & Training Limited aimed at Statisticians, clinicians, clinical research personnel. Anyone involved in setting up, or working with a data monitoring committee. It is also relevant to anyone serving on a data monitoring Committee.

About the presenter:

Simon has spent 30 years working in clinical trials, mostly in the pharmaceutical industry but also including five years at the UK and European regulatory agencies. He is a former president of the International Society for Clinical Biostatistics, a joint editor of Statistics in Medicine and previously joint editor of the Journal of the Royal Statistical Society. He has also served on editorial boards on a number of other journals, including Pharmaceutical Statistics, Controlled Clinical Trials and British Journal of Clinical Pharmacology. In 2012 he was elected a Fellow of the Society for Clinical Trials. He has served on a number of DMCs for small and large companies as well as for government-sponsored trials, and now works as a statistical and regulatory consultant to pharmaceutical and biotechnology companies around the world. He specialises in training and consulting on drug development programmes, scientific advice / end of Phase II meetings and preparations for oral explanations and advisory committees.

 Abstract

The course is relevant to all those (statisticians and non-statisticians) who need to set up data monitoring committees (DMCs) and work with them throughout the course of a clinical trial.  It is also relevant to those who may serve as members of DMCs. It will focus on practical issues around the workings of DMCs including a review of group sequential methods and FDA and CHMP guidance on DMCs. Throughout the course, mock DMC sessions will be convened where various scenarios will be considered and discussed, and decisions have to be made. The different practices in different areas (both medical and geographical), and the complexities that brings for the statisticians will also be discussed.

 Course Outline 

Introduction

  • Motivating examples, formal interim analyses, safety monitoring
  • Arguments for and against stopping trials early (scientific issues, ethical, regulatory)
 Overview of group sequential methods

  • Stopping ‘rules’
  • Haybittle and Peto, Pocock, O’Brien and Fleming, alpha-spending approach
  • Bayesian methods
 The roles of a DMC other than ‘stop/continue’ decisions
 Regulatory guidance

  • CHMP and FDA
  • Other guidance (e.g. WHO, NIH)
  • Interaction with regulators; what regulators might and might not do (and when)
 Composition and Responsibilities of DMCs
 How do DMC meetings run?

  • Frequency, location, structure, attendance
  • Conduct and communication
  • Practical problems (dissemination of information (including minutes), independence, communications)

Registrations start at 8:30am on the first day. Day 2 finishes at 1:00 pm.

 

Registration Fees:

Payment by 15 January2015 (Early Bird):   $600.00

Payment after 15 January 2015 until 19 February 2015:  $800.00

Concessions:

SSAI/APBG Members: $700.00

Full-time students: $700.00

(non members:- please email proof of your full time student status to [email protected] after registering)

Student membership is available for $20p/a. Regular membership is available for $230 p/a

Registrations close on 19 February 2015. Places are limited to 50.

The fee includes morning and afternoon tea as well as a light lunch on the first day and drinks on arrival and morning tea on the second day.

Travel Expenses

Occasionally workshops have to be cancelled due to a lack of subscription. Early registration ensures that this will not happen. However, please contact the SSAI Office before making any travel arrangements to confirm that the workshop will go ahead, because the SSAI will not be held responsible for any travel or accommodation expenses incurred due to a workshop cancellation.

 

Cancellation Policy

Cancellations received prior to 15 January 2015 will be refunded in full. Cancellations need to be accompanied by a valid credit card number and expiry date which will be used to put the refund through. After this time no part of the registration fee will be refunded. However, registrations are transferable within the same organisation. Please advise any changes to [email protected]

 

If you have any questions, please email Alan Brnabic at [email protected].

 

Data Monitoring Committees & Interim Analyses in Clinical Trials
When: 26/02/2015 - 27/02/2015
Time: 9:00 am - 4:30 pm
Cost: from $600.00
Location: MGSM CBD Executive Conference Centre,
37 Pitt Street,
Sydney,
NSW
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