Dear all!
The local RSS Highlands group will have it's first talk of the new season on Thursday, 21st of October (Details are given below). Please pass this information on to anybody who might be interested.
Please also note that the webpage of the Highlands group has moved to:
http://www.bioss.sari.ac.uk/RSSH/
Regards,
Claus-D. Mayer (local group secretary)
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TITLE: "Randomised controlled trials (RCT) post EU Clinical Trials Directive - some issues for statisticians"
SPEAKER: John Norrie, Director, Centre for Healthcare Randomised Trials (CHaRT), Health Services Research Unit, Aberdeen University
VENUE: Room WB27,Health Services Research Unit, Polwarth Building,
Foresterhill
TIME: Thursday 21st October at 5pm (tea and coffee from 4.45pm)
ABSTRACT:
The EU Clinical Trials Directive, along with other legislation and guidance, has given an exacting regulatory, ethical, and legal environment in which RCT are now conducted. This talk will give some observations on statisticians roles, from the perspective of an experienced triallist and statistician who has been involved in many RCT, both large and small, both publicy funded and ommercial, before and after the implementation of EU/CTD. The talk will include discussions of risk assessment of trials, some aspects of regulatory advice on both the design and analysis of RCT (via the Points to Consider series), and some thoughts on statisticians involvement in the monitoring of RCT.
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Claus-D. Mayer | http://www.bioss.ac.uk
Biomathematics & Statistics Scotland | email: [log in to unmask]
Rowett Research Institute | Telephone: +44 (0) 1224 716652
Aberdeen AB21 9SB, Scotland, UK. | Fax: +44 (0) 1224 716608
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