MRC-NIHR-Trials Methodology Research Partnership

Working Group Project Funding to Support Projects for Mental Health Mission: Innovative Clinical Trials Hub 2024/2025

 

The MRC-NIHR TMRP has been awarded funding for trials methodology research to support the development of an Innovative Clinical Trials Hub for Mental Health.

The Hub aims to transform the pace and scale of evaluation of interventions in common and severe mental health (MH) disorders by supporting:

 

i) Faster, streamlined clinical trials informed by patient priorities;

ii) Recruitment at scale from pre-consented, well-phenotyped, continually renewed, representative UK-wide cohorts in primary and secondary care; 

iii) Efficient investigation of mechanism and efficacy for new interventions;

iv) Trials methodology research specifically related to mental health; and

v) Industry partners at all scales.

 

The team working at the hub will work on a range of different types of trials for Mental Health, and different models for innovation, e.g. trials in primary care, mood disorder clinics, early psychosis clinics, trials with digitised elements, platform trials for digital therapeutics.

MRC-NIHR Trials Methodology Research Partnership (TMRP) is working with the teams from the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London and Office for Life Sciences  Mental Health Mission (OLS-MHM):

  • Richard Emsley, Academic Director of King’s Clinical Trials Unit, IoPPN, KCL
  • Mitul Mehta, Director of C-FIT, IoPPN, KCL
  • Husseini Manji, OLS Mental Health Mission co-Chair
  • Kathryn Abel, OLS Mental Health Mission co-Chair
  • Vaibhav Naranyan, OLS Mental Health Mission Chief Industry Officer

 

The hub, through the MRC-NIHR Trials Methodology Research Partnership funded several small project awards for TMRP members to undertake trials methodology research specifically related to mental health.

Lead Research Organisation Project Title and Report

Dr Brennan Kahan

University College London (UCL)

Guidance in the use of estimands in mental health trials.

Dr Sharon McCann

University of Aberdeen

Understanding influences on recruitment and retention in mental health trials: a rapid qualitative evidence synthesis and evidence mapping to identify solutions.

Dr Tim Morris

University College London (UCL)

Feasibility, opportunities and barriers to the use of n-of-1 designs to evaluate mental health interventions.

Dr Haiyan Zheng

University of Bath

 

Unlocking the potential of precision mental health – a pilot investigation focused on schizophrenia.

 

Dr Charlotte Hall

 

University of Nottingham

 

 

UNITE: UNderstanding Industrys Thoughts and Experiences of research partnerships: an exploratory investigation.

 

Dr Alexandra Wright-Hughes

University of Leeds

 

Initial steps in the development of a core outcome set (COS) for the treatment and prevention of post-stroke psychological problems.

 

Dr Brennan Kahan

University College London (UCL)

Increasing efficiency in mental health trials by developing statistical methods to overcome challenges in crossover designs.

Dr Brennan Kahan 

 

University College London (UCL)

 

An evaluation of informative cluster size in mental health trials to determine whether standard statistical methods are robust and reliable.

 

Professor Carrol Gamble

 

University of Liverpool

 

Carbon footprinting mental health trials. 

 

Professor Carrol Gamble

 

University of Liverpool

 

Challenges of Early-Phase Research: Design Considerations in trials of medicinal products for depression. 

 

Dr Kim May Lee 

 

King's College London and Newcastle University

 

Adaptive designs for mental health trials on complex interventions.

 

Dr Kim May Lee 

 

King's College London

 

Inclusive designs for superiority studies in mental health.

 

Dr Nicholas Turner

 

University of Bristol

 

Learning curve effects in randomised controlled trials of mental health therapy interventions.

 

Professor Paula Williamson

University of Liverpool

A review of core outcome sets for mental health conditions.