Extending the estimands framework to randomised trials of complex interventions Ref: 5223

Supervisors

Professor Siobhan Creanor, University of Exeter

Dr Fiona Warren, University of Exeter

Professor Gordon Taylor, University of Exeter

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). 

NIHR Exeter BRC Commitment

This Studentship will be nested within the National Institute of Health and Care Research Exeter Biomedical Research Centre (NIHR Exeter BRC), hosted by the Royal Devon University Healthcare NHS Foundation Trust in partnership with the University of Exeter and in collaboration with South West NHS organisations. The first of its kind for the South West peninsula, the Centres fundamental objective is to improve health outcomes for patients and the public by translating scientific breakthroughs into potential new treatments, diagnostics and medical technologies.

This studentship will provide the opportunity to work with world-leading researchers and have access to state-of-the-art facilities. The NIHR Exeter BRC are committed to developing and nurturing a diverse and rich pipeline of talented researchers by equipping them with the knowledge and skills to excel and contribute significantly to the local and national economy via the delivery of high-quality and impactful translational biomedical research. Expertise will be harnessed from across the partnership to deliver the best possible training and career development opportunities, with the student provided the opportunity to be embedded in a rich research culture, with a growing body of early career researchers.

We are delighted to have already recruited some exceptionally talented researchers at various career stages to our NIHR Exeter BRC, including  Senior Investigator Fellows, Translational Fellows and our first cohort of PhD students who started with us in September 2023 in addition to a second cohort who will start with us in September this year.

Fees and funding

For eligible students, the studentship will cover Home tuition fees plus an annual tax-free stipend of at least £19,237 (in alignment with standard Research Council UK rate) for 3 years full-time, in addition to a Research Training and Support Grant (RTSG). The student will be based in the Exeter Clinical Trials Unit at the St Lukes Campus.

*Students who pay international tuition fees are eligible to apply, but should note that the award will only provide payment for part of the international tuition fee and no stipend. International applicants need to be aware that you will have to cover the cost of your student visa, healthcare surcharge and other costs of moving to the UK to do a PhD.

The conditions for eligibility of home fees status are complex and you will need to seek advice if you have moved to or from the UK (or Republic of Ireland) within the past 3 years or have applied for settled status under the EU Settlement Scheme.

Timeline

The closing date for applications is midnight on January 6th 2025.

Interview panels are anticipated to be held virtually week commencing the 3rd / 10th February 2025.

Expected start dates are between September 2025.

Contact details

If you would like to discuss the studentships further, please contact the primary supervisor as stated in the advert. If you have any queries surrounding the application process or the BRC more generally, please contact Dr Sophie Gould (NIHR Exeter BRC Training and Events Manager) at S.L.Gould@exeter.ac.uk.

Entry requirements

Applicants for this studentship must have obtained, or be about to obtain, a First or Upper Second Class UK Honours degree, or the equivalent qualifications gained outside the UK, in an appropriate subject area.

If English is not your first language you will need to meet the required level as per our guidance at https://www.exeter.ac.uk/pg-research/apply/english/

How to apply

Apply now

In the application process, you will be asked to upload several documents

• CV – all aspects below must be included, if applicable.
 Contact details
 Education history
 Work history
 Work experience (voluntary and/ or paid)
 Professional development and skillset e.g. certification, courses, workshops, conference attendance/ presentations
 Publications and awards

• Letter of motivation (maximum 2 pages)
Please note that your application will be assessed on research ‘potential’ as opposed to research ‘experience’ to allow candidates who have not had the resources or opportunities to have internships or study for a master’s degree to be assessed on equal terms with those who have had these opportunities.
Please use the guiding questions/areas below to structure your letter of application.
 What it is about this particular research area that interests you (e.g. your interest/understanding of the research question, your skills/experience that fit with this project)?
 How will this PhD studentship help you achieve your future career goals?
 Examples of your achievements in research related activities (e.g. undergraduate, internships, masters or postgraduate work experience).
 Example of your achievements in non-research related activities (e.g. outside of academic study).
 Any additional relevant information to support your application. Including, any mitigation factors you wish to make the selection committee aware of for consideration during the assessment of your application e.g. career breaks due to parental leave or periods of illness, reduced time for career progression due to disability or caring responsibilities, or reduced opportunities to career support.

NIHR Exeter BRC recognises that you may be reluctant, or uncomfortable disclosing relevant information that is sensitive. However, you should bear in mind that that we are unable to take into account factors that you do not disclose. Please be assured that information provided by you is sensitive and will be treated confidentially and in line with General Data and Protection Regulations (GDPR).

• Transcript(s) giving full details of subjects studied and grades/marks obtained (this should be an interim transcript if you are still studying).
• Two references.  If you are not able to upload your reference documents with your application please ensure you provide details of your referees for information.  If you provide contact details of referees only, we will not expect receipt of references until after the shortlisting stage. Your referees should not be from the prospective supervisory team. 
• If you are not a national of a majority English-speaking country you will need to submit evidence of your proficiency in English

Our Equality, Diversity, and Inclusion Commitment

The NIHR Exeter Biomedical Research Centre (BRC) and Clinical Research Facility (CRF) strongly adhere to Equality, Diversity and Inclusivity (EDI) principles. They share a fundamental objective to empower better health outcomes for all patients and the public by translating scientific breakthroughs into potential new treatments, diagnostics and medical technologies. 
We are committed to ensuring that the consideration of EDI is second nature to all members of our experimental medicine and translational research community, fostering a fully inclusive environment where everyone feels supported, valued, and is provided the opportunity to reach their full potential.
Our strategy purposefully shares overarching EDI visions with those of the NIHR, UoE and NHS Trust partners to allow for collaborative working to reach our mutual goals. Whilst all applicants will be judged on merit alone, we particularly welcome applications from groups currently underserved within our working community.

Summary