Theme Day: Clinical Trials

Thursday 14 August 2008

Isaac Newton Institute for Mathematical Sciences, Cambridge, UK

Organisers: Professor R Bailey (Queen Mary, London), Dr B Bogacka (Queen Mary, London), Dr H Grossmann (Queen Mary, London) and Dr D Woods (Southampton).

in association with the Newton Institute programme Design of Experiments (21 July to 15 August 2008)

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Theme:

Clinical trials are experiments on living animals and humans to explore a proposed treatment for a disease and to obtain a licence for the commercial use of the treatment on non-experimental patients.

The experimental programme is often described as having several phases. Assessment of the treatment starts with healthy individuals to check the absence of adverse reactions. Experiments are then designed to determine the dosage, sometimes constrained by a need to avoid toxicity. The large Phase III trials are used to determine the advantages, if any , of the new treatment often by comparison with existing treatments. Randomization and balance over covariates are especially important in this phase.

Regulatory authorities, such as the American FDA, are rightly concerned that the designs have specified properties and are analysed in a pre-specified way. Sample size and power are two important characteristics.

However, a too rigid analytical straightjacket can conflict with the efficiency of statistical procedures if unexpected evidence becomes available during a trial. Protocols for interim analyses or changes in emphasis have to be tightly specified, in order that biases are avoided and test size and power maintained.

Particularly with human patients there is also the ethical desire to treat as many patients as possible with the better treatments. This leads to group sequential and response adaptive designs where the allocations change as responses on earlier patients become available. Controlling the properties of such trials is a complex task.

Confirmed speakers include:

Peter Müller (Texas M.D Anderson Cancer Center), Anthony Atkinson (LSE) and Peter Thall (Texas M.D. Anderson Cancer Center). (more speakers will be added shortly)

Schedule:

There will be three scientific sessions and ample opportunity for informal interaction.

11:00 11:30 Registration and Coffee
11:30 12:30 Session I
12:30 13:30 Lunch
14:00 15:30 Session II
15:30 16:00 Tea
16:00 17:30 Session III

Accommodation and Costs:

There is a daily registration fee of £30 (reduced to £20 for students) which includes admission to all seminars, lunch and refreshments but does not include dinner or accommodation.

The daily accommodation fee is £55, this fee includes a registration fee, bed and breakfast accommodation for one night together with lunch and refreshments (Monday to Friday only).

Accommodation is available from Sunday 10 August to breakfast on Saturday 16 August 2008

Accommodation and meals (breakfast and lunch) are provided at Wolfson Court, next to the Newton Institute where single study bedrooms with shared bathrooms are available. Please note dinner is not included in this fee. Delegates are expected to arrange their own evening meal.

Some support may be available for PhD students and early career researchers (within 5 years of PhD) under the Institute's Junior Membership scheme.

Sponsored by:

JMP from SAS GlaxoSmithKline
GenStat The Royal Statistical Society

Fisher Memorial Trust

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