How do Data Monitoring Committees Operate

How do Data Monitoring Committees Operate: Principles, Practicalities and Controversies

Agenda | Slides | Recordings

Wednesday 5th November 2014
RSS Offices, Errol Street, London


This one day meeting is aimed at people who serve on Data Monitoring Committees, people who organise them, and people involved in preparing statistical reports and safety listings for them. The day will cover the remit and organisation of DMC’s, together with speakers’ personal experiences of the process.

Agenda

9:15  Issues in the Construction and Conduct of DMCs
Dr Richard Kay (RK Statistics Ltd) 
10:00 The roles of a DMC other than ‘stop/continue’ decisions
Andrew Stone (Astra Zeneca) 
11:00 Experiences of data monitoring and interim analysis of trials in the public sector
Prof. Diana Elbourne (LSHTM) / Dr Patrick Phillips (MRC) 
11:45 Regulatory guidance and expectations concerning DMCs
Dr Yolanda Barbachano (MHRA) 
13:30 The role of a programmer during a DMC delivery
Diana Stuart (CMed) 
14:15 The role of the industry statistician during a DMC delivery
Nicola Tyson (Roche Ltd) 
15:00 Reasons why physicians and statisticians are needed for a DMC
Dr Jo Glover (Coephycient Pharmaceutical Consultancy) 
 15:45 Controversial Case Studies on When to Stop a Trial Early
Prof. Stuart Pocock (LSHTM) 

Slides

Slides from the day are posted below. These slides are available to PSI members only, so please log onto the website in order to gain access.

 
Issues in the construction and conduct of DMCs

The roles of a DMC other than stop/continue decisions 

Regulatory guidance and expectations concerning DMCs

Reasons why physicians and statisticians are needed on a DMC

The role of the industry statistician during a DMC delivery

Controversial case studies on when to stop a trial early  

Recordings

Please see below recordings from some of the talks presented on the day. The sound quality of some of the talks is imperfect due to some technical issues experienced at the venue.

Issues in the construction and conduct of DMCs 



The roles of a DMC other than stop/continue decisions



Regulatory guidance and expectations concerning DMCs



Reasons why physicians and statisticians are needed on a DMC



The role of the industry statistician during a DMC delivery



Controversial case studies on when to stop a trial early

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