Data and Safety Monitoring Board Workshop
25 November

Dose-escalation Procedures in Phase I Clinical Trials
26-27 November

Group Sequential Clinical Trials -Design, Interim and Final Analyses
28-29 November


Full details are given below.

For further details or to book, please contact
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http://www.reading.ac.uk/mps



Data and Safety Monitoring Board Workshop

Presenters John Whitehead and Sue Todd

Guest Presenter Julian Bion
Reader in Intensive Care Medicine
Queen Elizabeth Hospital, Birmingham

25 November

£300 (with discount if booked more than 6 weeks in advance)

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



Dose-escalation Procedures in Phase I Clinical Trials

Presenters John Whitehead and Yinghui Zhou

Guest Presenter Sally Ritchie, GlaxoSmithKline

26-27 November

£600 (with discount if booked more than 6 weeks in advance)

Audience The course is intended for statisticians and clinical pharmacologists
working in early phase drug development in pharmaceutical companies and public
sector medical research institutes.

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. 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



Group Sequential Clinical Trials -Design, Interim and Final Analyses

Presenters John Whitehead and Kim Bolland

28-29 November

£600 (with discount if booked more than 6 weeks in advance)

A clinical trial in which treatments are compared in a series of interim
analyses is called sequential or group sequential. This course begins with a
review of the dangers inherent in the naïve use of interim analyses, before
introducing valid methodology. Emphasis is given to the choice of a design that
will achieve the scientific and ethical requirements of an individual trial.
Design systems such as the boundaries approach and the (-spending method are
described, and the conduct of interim analyses discussed. Methods for analysing
the final data set, producing valid p-values, unbiased estimates and confidence
intervals, are studied. The preparation of data for interim analyses and the
role of Data and Safety Monitoring Boards are discussed.

Hands-on practical work using the computer package PEST 4 (Planning and
Evaluation of Sequential Trials) and group discussions are used to deepen
understanding of the issues covered. Previous knowledge of PEST 4 is not
assumed.

At the end of the course a participant should be in a position to design,
conduct and analyse a sequential clinical trial involving two treatments.


Programme

Introduction to sequential methods
Choice of stopping boundaries
Conduct of interim analyses
Analysis at termination
Adjustment for prognostic factors
Examples of sequential trials
Practical organisation of a sequential study
Survival trials and safety monitoring