Trial design and analysis considerations at the boundary between simple and complex interventions

Objectives

The candidate will (i) review the relevant methodological and clinical literature, (ii) explore and re-analyse datasets available to the supervisory team (e.g. DARS, FEVER, HSEN), highlighting and exploring in detail considerations for the analysis, (iii) provide recommendations and guidance for the design and primary analysis of complex drug trials, set within a general framework. They will be encouraged to consider novel design options, explored through simulation with associated analysis implications. Through real historical and prospective examples, the candidate will reflect on practical considerations.

Summary

CONSORT describes complex interventions as ‘non-pharmacologic treatments’; MRC as interventions containing several interacting components. What makes an intervention complex from a statistical perspective is that they need a number of treatment variables to adequately represent them in an analysis. A drug can be regarded as simple only if its effect can be represented by a single treatment variable and can be separated from the effect of co-interventions due to blinding. The consequences of complexity are becoming accepted for trials evaluating a treatment delivered by a health professional (e.g. talking therapies or surgery). Less attention has been paid to the boundaries between simple and complex interventions. These include distinct components of drug regimes (e.g. dopamine augmented rehabilitation in stroke), (ii) prescriber-related clustering and context effects in open-label drug trials (e.g. psychiatrist effects), (iii) tailoring of a drug intervention (e.g. individual titration of Ritalin or administration of a booster dose of vaccine where necessary), and (iv) drugs provided at a (sub) population level (e.g. to avoid infection spreading in a care home setting). The candidate will review the methodological and clinical literatures, re-analyse existing datasets, provide recommendations and guidance for the design and primary analysis of complex drug trials and explore practical, design and analysis considerations. This project sits within a larger programme of work on developing methods for evaluating complex healthcare interventions.

Eligibility

You should hold a first degree equivalent to at least a UK upper second class honours degree in a relevant subject (mathematics, statistics, psychology). Ideally candidates should have, or be about to complete, an MSc in a relevant subject.

Candidates whose first language is not English must provide evidence that their English language is sufficient to meet the specific demands of their study, the Faculty minimum requirements are:

• British Council IELTS - score of 6.5 overall, with no element less than 6.0
• TOEFL iBT - overall score of 92 with the listening and reading element no less than 21, writing element no less than 22 and the speaking element no less than 23.

How to apply

To apply for this scholarship applicants should complete a Faculty Scholarship Application form using the link below http://medhealth.leeds.ac.uk/download/2376/fmh_scholarship_application_16_17_entry and send this alongside a full academic CV, degree transcripts (or marks so far if still studying) and degree certificates to the Faculty Graduate School [Email Address Removed]

We also require 2 academic references to support your application. Please ask your referees to send these references on your behalf, directly to [Email Address Removed] by no later than Tuesday 6 December 2016.

Any queries regarding the application process should be directed to [Email Address Removed]

For further information about projects contact Dr Rebecca Walwyn by emailing [Email Address Removed] and include your brief CV.