Re-announcement of short-course being offered by the Medical and Pharmaceutical Statistics Research Unit at The University of Reading UK, for the week beginning 24 October 2005:
1. Dose-escalation Procedures in Phase I Clinical Trials (2 days)
2. Analysis of Multiple Failure Time Data Arising from Clinical Trials (2 days)
3. Data and Safety Monitoring Board Workshop (1 day)
Details are given below
or
visit www.rdg.ac.uk/mps/mps_home/courses/scheduled_c.htm
or
contact Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240, Earley Gate
Reading, RG6 6FN
Tel: +44 118 378 6662
e-mail: [log in to unmask]
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Dose-escalation Procedures in Phase I Clinical Trials
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Date: 24-25 October 2005
Presenters: Professor John Whitehead and Dr Yinghui Zhou
Audience:
This course is intended for statisticians and clinical pharmacologists working in early phase drug development in pharmaceutical companies and public sector medical research institutes.
Description:
Phase I clinical trials conducted to find appropriate doses for use in later phase studies employ pre-specified guidelines. These determine what dose to administer to the next subject or group of subjects. Recent research by statisticians has led to the development of new dose-escalation schemes with the potential for increasing efficiency and safety. So far these schemes have been implemented to a limited extent in trials of cancer drugs, and hardly at all in other therapeutic areas.
The objectives of this course are to introduce the new procedures and their underlying principles, to demonstrate software for their implementation and to show how these and older procedures can be evaluated using simulation. Applications to oncology trials and to studies in other therapeutic areas are discussed, and designs for healthy volunteer studies with pharmacokinetic endpoints are presented. The intention is to stimulate discussion about whether and in what form the new procedures are of practical utility. In addition to lectures, there will be practical sessions and group discussions.
Programme:
* Conventional dose-escalation procedures
* The Continual Reassessment Method
* Bayesian dose-escalation procedures
* Healthy volunteer studies
* Simultaneous monitoring of benefit and toxicity
* Software for dose-escalation
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Analysis of Multiple Failure Time Data Arising from Clinical Trials
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Date: 26-27 October 2005
Presenters: Dr Patrick Kelly and Professor Anne Whitehead
Description:
Statistical methods have recently been developed for the analysis of multiple failure time data. Such data can arise in a variety of ways. Sometimes analyses based on two endpoints, such as time to disease progression and time to death, are to be combined. Recurrent event data are observations of times at which patients suffer repeated events such as epileptic seizures, asthma attacks or coronary events. Competing risks data arise when considering various potential causes of death or forms of incapacity that can follow from a certain condition. Clustered survival data, which arise, for example, from multicentre trials, can also be considered as a form of multiple failure time data.
Examples of such data will be examined, and the objectives of their analysis discussed. Methods, such as frailty models, and the robust approach due to Wei, Lin and Weissfeld will be introduced and illustrated. The software available for implementing these methods will be described and participants will take part in hands-on computer practicals.
Although the course will begin with a brief review, it will be assumed that participants are familiar with simple univariate survival techniques.
Programme:
* Examples of multiple failure time problems
* Review of survival methods
* Combining survival endpoints
* Frailty models for correlated survival data
* Models for recurrent event data
* Competing risks models
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Data and Safety Monitoring Board Workshop
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Date: 28 October 2005
Presenter: Dr Sue Todd
Guest Presenter: Dr Julian Bion
Reader in Intensive Care Medicine
Queen Elizabeth Hospital, Birmingham
Audience:
This Workshop is designed for people who serve on Data and Safety Monitoring Boards, people who organise them, and people involved in preparing adverse event and statistical reports for them.
Description:
Data and Safety Monitoring Boards (DSMBs) are a common feature of long-term clinical studies in life-threatening conditions. This Workshop describes the remit and composition of DSMBs, and how their work relates to other parties involved in the study, such as the sponsor, the study project team, the investigators, the Steering Committee and the data management centre. The importance of pre-trial preparation by the DSMB is stressed. Consideration is given to the nature and purpose of safety and efficacy data reports presented to the DSMB, and the balance between the timeliness and the accuracy of the data available is discussed. Statistical problems inherent in repeatedly making multiple treatment comparisons are highlighted, and formal stopping guidelines based on repeated safety analyses are presented. The role of the DSMB in trials with pre-specified interim efficacy analyses will be discussed.
The Workshop is structured around group discussions of realistic scenarios of the type faced by DSMBs.
Programme:
* Role and composition of a DSMB
* Confidentiality and blindness
* Presentation of safety reports
* Formal stopping rules for safety
* Interim efficacy analyses and sequential designs
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Course fees
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For 6 or more weeks prior to commencement of the course:
1 Day 2 Days
Students £180 £360
Sponsors/Public £225 £450
sector/Academic
Other £255 £510
Less than 6 weeks
prior to course £300 £600
The course fee includes all supporting documentation, refreshments and lunches. For a course running more than one day, dinner is included on the first evening.
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