Places are available on the following courses. Details, including costs,
are given below.
For more information, please contact [log in to unmask]
25-26 October
Analysis of Multiple Failure Time Data Arising from Clinical Trial
27-28 October
Meta-analysis of Clinical Trials
29 October
Data and Safety Monitoring Board Workshop
Analysis of Multiple Failure Time Data Arising from Clinical Trials
Presenters: John Whitehead, Patrick Kelly and Shah Jalal Sarker
Statistical methods have recently been developed for the analysis of multiple
failure time data of various forms. 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,
such as arise 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
Meta-analysis of Clinical Trials
Presenters Anne Whitehead and John Whitehead
The rapid increase in the number of meta-analyses being conducted in the medical
world during the last twenty years has been mainly due to greater emphasis on
evidence-based medicine and the need for reliable summaries of the vast and
expanding volume of clinical research. At the same time there have been great
strides in the development and refinement of the associated statistical
methodology. This course concerns the planning, conduct and reporting of a
meta-analysis as applied to a series of randomised controlled clinical trials.
The course presents a general framework for meta-analysis, applicable to binary,
ordinal, time to event or normally distributed patient responses. Fixed and
random effects models for combining study summary statistics or individual
patient data will be presented. Methods of dealing with heterogeneity as well
as Bayesian approaches are examined, together with preparation of a
meta-analysis protocol and reporting of results. In addition to lectures, there
will be practical sessions and group discussions based on published examples of
meta-analyses. Anne Whitehead is the author of the new book 'Meta-Analysis of
Controlled Clinical Trials', Wiley: Chichester, 2002.
Programme
* A general framework for meta-analysis
* Binary, ordinal, time to event and normally distributed data
* Combining study summary statistics or individual patient
data using fixed and random effects models
* Protocol development
* Presentation and interpretation of results
* Dealing with heterogeneity and selection bias
* Retrospective vs prospective meta-analyses
* Cumulative meta-analysis
* Bayesian methods
Data and Safety Monitoring Board Workshop
1 day
Presenter Sue Todd
Guest Presenter 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.
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
Course duration
1 day 2 days 3 days
Students £180 £360 £540
Sponsors/Public
sector/academic £225 £450 £675
Other £255 £510 £765
For bookings made less than 6 weeks prior to commencement of the course the
following fees apply
1 day 2 days 3 days
£300 £600 £900
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.
Cancellation
Registrations are transferable to another course or individual at any time,
otherwise cancelled course registration will incur the following charges:
11 - 20 days before the start of the course 50%
1 - 10 days before the start of the course 90%
course start date or later 100%.
We reserve the right to cancel any course without liability other than a refund
of the course fee.
For further information please contact
Barbara Dodds
MPS Research Unit
The University of Reading
PO Box 240, Earley Gate
Reading RG6 6FN, UK.
Tel: +44 118 378 6662
Fax: +44 118 975 3169
E-mail: [log in to unmask]
http://www.reading.ac.uk/mps
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