Apologies for cross-postings.
Forthcoming MPS Research Unit courses to be held at the University of Reading, UK, June 19-23:
1. Dose-escalation Procedures in Phase I Clinical Trials
2. Proof-of-concept Studies (NEW)
3. Meta-analysis of Clinical Trials
See below for further details or visit
http://www.rdg.ac.uk/mps/mps_home/courses/scheduled_c.htm
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Dose-escalation Procedures in Phase I Clinical Trials
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2 days
Presenters Yinghui Zhou and John Whitehead
19-20 June
Audience This course is intended for clinical pharmacologists and statisticians 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. 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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Proof-of-concept Studies (NEW)
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1 day
Presenters John Whitehead and Elsa Valdés-Márquez
21 June
Proof-of-concept studies are phase IIa clinical trials, usually conducted within the target patient group, to determine whether the considerable resources necessary to complete drug development should be invested. In some cases a simple GO/NO GO decision is sought. Often, however, a decision to GO has to be accompanied by a choice of a dose or range of doses, or of a specific formulation or dosing schedule.
The proof-of-concept study provides the sponsor with evidence on which to base an important commercial and public health decision. Regulators have expressed the view that it does not matter how a drug finds its way into phase III, as if it clearly succeeds at that stage then it will win a licence. It is in the sponsor's interest to undertake well designed proof-of-concept studies in order to deliver such winners to phase III regularly and reliably. The whole array of statistical methods, frequentist, Bayesian and decision-theoretic is available to help them achieve this.
In this course, the role of the proof-of-concept study and its place in the clinical evaluation of a new medical therapy will be described. A variety of study objectives and of statistical approaches to realising them will be discussed. Group discussions will allow participants the opportunity to consider the choice of design within realistic trial settings.
Programme
* Aims of proof-of-concept studies and approaches to them
* Two-stage Simon designs and related frequentist
approaches
* Bayesian monitoring, and the approach of Thall and Simon
* Decision-theoretic approaches
* Surrogate and multiple endpoints
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Meta-analysis of Clinical Trials
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2 days
Presenters Anne Whitehead and Mark Simmonds
22-23 June
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 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
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Fees
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For bookings made 6 weeks or more prior to commencement of the course the following reduced fees apply
1 day 2 days
Students £180 £360
Sponsors/Public £225 £450
sector/Academic
Other £255 £510
For bookings made less than 6 weeks prior to commencement of the course the following fees apply
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.
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Location
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Reading, UK is situated on the River Thames, 40 miles west of London. The town is easily accessible from Heathrow airport (45 mins) by regular coach service or taxi. Courses take place at Whiteknights Park, a spacious and attractive campus of the University of Reading, 3 miles from the town centre.
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Contact details
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For further information about the MPS Research Unit or for a booking form for a professional development course, 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]
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