Statistical and Data Management aspects of dealing with Data Safety Monitoring Boards

Date	June 21, 2006
Place	Solvay Pharmaceuticals, Weesp
Organisation	BMS Working group PSDM

09:30	Registration and coffee
10:00 ÷ 10:45	Interim analysis on Survival Data: its potential bias and how to repair it. Theo Stijnen Erasmus Medical Center, Rotterdam
10:45 ÷ 11:30	Data Safety Monitoring: experiences Trudi Klaassen, Peggy Helmyr Organon Oss
11:30 ÷ 12:00	Coffee/Tea break
12:00 ÷ 12:45	Implementation of Real-Time Learning Tom Parke Tessella, UK
12:45 ÷ 13:30	Lunch
13:30 ÷ 14:15	Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group. Alan Philips ICON Clinical Research, Buckinghamshire
14:15 ÷ 15:00	To be determined
15:00 ÷ 15:30	Coffee/Tea break
15:30 ÷ 16:15	EFSPI: European Federation of Statisticians Working in the pharmaceutical industry. Kit Roes Organon, Oss
16:15 ÷ 17:00	Annual Meeting of PSDM. The annual meeting is open to all interested persons. (Information and annual report will be distributed at a later stage)
16:45	Closure followed by an informal drink

Summaries:

Interim analysis on Survival Data: its potential bias and how to repair it
Prof. Theo Stijnen, Erasmus Medical Center, Rotterdam

The presentation, based on a publication together with Hans van Houwelingen and Cornelis van de Velde (Statistics in Medicine 2005; 24:2823-2835), shows and illustrates with an example that if the PH assumption in the analysis of a time-to-event event analysis is violated, the results of interim analyses can be biased. It is also shown how the bias can ban be remedied. The consequences for design and analysis are discussed and practical recommendations given.

Data Safety Monitoring: experiences
Trudi Klaassen and Peggy Helmyr, Organon Oss

The mission, responsibility and consequences of having a DSMB in a clinical trial. Experiences and learned lessons on a clinical data management level.

Implementation of Real-Time Learning
Tom Parke, Tessella, UK

The continuous data monitoring of clinical trials is a challenge from a logistical point of view. This presentation will address specifically the logistical problems of real-time learning and adaptation in clinical trials; simulating the trial, optimizing the trial parameters, getting sufficient live data, trial management and analysis tools.

Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group
Alan Philips, ICON Clinical Research, Buckinghamshire, UK

Adaptive designs have potential utility in late-phase development. An area where adaptive designs can be particularly beneficial is to allow dose selection in pivotal trials via adding/dropping treatment arms; for example phase II and II of the drug development program. The more adaptations made during a late-phase clinical trials, the less likely that the clinical trials would be considered as a confirmatory trial. This presentation outlines the issues raised, resulting discussions and consensus views reached during a PSI meeting on this topic.

EFSPI: European Federation of Statisticians Working in the pharmaceutical industry
Kit Roes, Organon, Oss

In this presentation, Kit Roes, who is currently the president of EFSPI, will give an update on the current activities and strategies of EFSPI. Current topics are amongst others new draft Regulatory guidelines, joint meetings of various member organizations, the JAMA editorial, ethical codex for statisticians. There will be time for discussion on the joint goals of EFSPI and PSDM and how these goals can be achieved.