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Applications are invited for a 4 year PhD studentship at Warwick Medical School (WMS), University of Warwick, UK. The studentship is funded jointly by the Medical Research Council (MRC) and Novartis Pharma AG, Basel, Switzerland.

 

Project title: New methods for estimating treatment effects in trials that use adaptive seamless designs

 

Background: In order to accelerate development of new drugs, new designs referred to as adaptive seamless designs (ASDs) have been proposed in clinical trials. ASDs include one or more interim analyses partway through the trial to make some adaptation. We will consider two-stage ASDs where the adaptation is treatment selection. In stage 1, several experimental treatments are compared to a control. After stage 1, an interim analysis using stage 1 data is performed to select the most promising experimental treatment. At stage 2, additional patients are allocated to the control and the selected treatment. Data collected in stages 1 and 2 are used in the final confirmatory analysis. This may lead to smaller sample sizes because unlike the traditional testing procedures, data used in treatment selection are also used in the confirmatory analysis. However, although efficient, such a design poses statistical challenges as the methods used to analyse a trial that uses an ASD need to adjust for the treatment selection.

 

The project: In this studentship, the focus will be point estimation of treatment effects. Methods for point and interval estimation that adjust for treatment selection have been proposed by several authors. However, most authors consider normally distributed outcomes while a few consider binary outcomes. In this project, we will consider survival outcomes which have not been thoroughly investigated with respect to treatment selection bias. Survival outcomes are important and common in medical research such as in oncology. During the studentship, new point estimators that adjust for treatment selection will be developed.

 

Supervisors: The student will have supervision from WMS and Novartis. The supervisors at WMS will be Dr Peter Kimani and Professor Nigel Stallard and the supervisors at Novartis will be Dr Ekkehard Glimm and Professor Frank Bretz.

 

The studentship: This joint studentship between MRC and Novartis includes full tuition fees for an EU/UK application and an annual tax-free stipend of approximately £16,200. The student will be based at WMS and will enrol on the WMS postgraduate student training programme. Registration will initially be for an MPhil degree. Upgrade registration for a PhD in Health Sciences will follow presentation of a satisfactory report at the end of the first year. Over the 4 years, the student will spend at least a total of 3 months at Novartis in order to meet the industry supervisors and to discuss the relevance of the research to real trials.

 

Candidates should have a good honours degree (2.1 or above) or a higher degree including a substantial component of mathematics and/or statistics and must satisfy the MRC Industrial case studentship eligibility requirements (see http://www.mrc.ac.uk/Fundingopportunities/Applicanthandbook/Studentships/Eligibility/index.htm ). An interest in clinical trials is essential.

 

The expected start date is:  1 October 2013.

 

The environment: The University of Warwick is one of the UK’s leading research universities. WMS’s research is focussed around a number of multidisciplinary and cross-specialty teams; collaboration within and outside the School and University is encouraged and investigators are encouraged to work across traditional disciplinary boundaries in innovative ways. WMS has several medical statisticians who provide support for the research work of the medical school and local NHS through the provision of advice on the analysis of data and the design of research studies as well as conducting research in applied statistical methodology. One of the strongest expertise areas in the statistical methodology research is sequential and adaptive clinical trial design. The medical statisticians regularly meet for Medical Statistics Discussion Group seminars to present and discuss their work.

 

The student will be encouraged to interact with WMS statisticians and to participate in WMS Medical Statistics Discussion Group seminars, and will also benefit from relevant seminars in the Warwick University Department of Statistics.

 

Novartis, the industry partner, is one of the industry leaders in the implementation of novel clinical trial designs, with a number of their staff actively engaged in methodological research in ASDs. This offers the student a unique opportunity to collaborate with an organisation that will offer support in statistical methodological expertise and experience in conducting real trials.

 

Applying: To apply please complete the online application form (https://postgrad.warwick.ac.uk/SWIFT/pgapp/login.asp) indicating that you are applying for the MRC Industrial Case Studentship on New methods for estimating treatment effects in trials that use adaptive seamless designs supervised by Dr Peter Kimani.

 

Additionally please provide a CV and covering letter by post or e-mail, including two referees to:

Dr Peter Kimani

                        Warwick Medical School

                        University of Warwick

                        Coventry CV4 7AL, UK

(E-mail: [log in to unmask])

 

For further details or informal discussion of this studentship, please contact Peter Kimani ([log in to unmask]).

 

We reserve the right to close this studentship early once we have received sufficient applications and therefore encourage you to apply early to avoid disappointment.