PhD Studentship: Extending the Estimands Framework to Randomised Trials of Complex Interventions

Project description:

Complex interventions are characterised as having several potentially interacting components.  There are unique methodological considerations in designing and analysing randomised trials to evaluate complex interventions. These include adherence, potential for the intervention (and/or control) to be delivered in a group-setting and other potential intercurrent events (such as use of additional or alternative interventions).

The estimands framework is a way to breakdown and specify exactly the main question a trial is aiming to answer.  By precisely specifying the research question, including identifying important intercurrent events, appropriate statistical methods can be planned to ensure that the statistical analyses answer the question.  However, the estimands framework was developed for drug trials and therefore does not consider all the issues pertinent to trials of complex interventions.

The aim of this studentship is to consider how the estimands framework should be adapted and used for randomised trials of complex interventions.  Objectives include:

• Assessing the suitability of the estimands framework for complex intervention trials.
• Identifying additional elements needed for the framework in these trials.
• Developing methods to handle common types of intercurrent events in complex intervention trials.
• Re-analysing completed trials to compare and assess the new statistical methods.
• Developing guidance for applying the estimands framework in complex intervention trial design and analysis.

Methods may include (i) a scoping or systematic review; (ii) reviewing current and developing new statistical methods; (iii) applying the statistical methods to one or more completed trial datasets; (iv) consensus work to develop new guidance. There will be opportunities to seek input from the public and patients throughout the project.

The student will join the statistics team in the UKCRC-registered Exeter Clinical Trials Unit (CTU).

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