The road to funding for a complex clinical trial – ingredients for success

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Dr Eszter Szilassy

 

 

 

Dr Eszter Szilassy, IRIS+ Trial Principal Investigator, Senior Research Fellow and Senior Lecturer in Violence and Health, Centre for Academic Primary Care, University of Bristol

On 1 May 2024, I held the first meeting of the IRIS+ Trial, a complex clinical trial to improve the general practice response to domestic abuse, which had been made possible by an award of £2.2 million from the National Institute for Health and Care Research (NIHR). As I sat with colleagues, I couldn’t quite believe that we were finally ready to go. The journey started two and a half years ago on the back of a feasibility study, which was successful, but not yet published. As a mid-career researcher, this was my first major grant application as Principal Investigator. I had much to learn on the way and was reliant on a lot of support from both academic and non-academic collaborators. In the hope that it may help other researchers seeking to take a similar leap, I am sharing what I believe were the essential ingredients for success. But first, a bit about the IRIS+ programme.

IRIS+ – the feasibility study

The IRIS+ intervention development work started in 2016 as part of the National Institute for Health and Care Research (NIHR) funded REPROVIDE Programme. IRIS+ is an extension of the IRIS programme — a specialist domestic violence and abuse training, support and referral programme in general practices for the identification and referral of women experiencing domestic abuse. It sits both inside and outside of the NHS. While continuing to address the needs of women, IRIS+ extends support to men (experiencing or perpetrating domestic abuse) and to children and young people living with domestic abuse or experiencing it in their relationships. Building on previous research and extensive mapping and consultation work, our team, in collaboration with IRISi, Next Link and Women’s Aid, developed and tested the feasibility of IRIS+ in England and Wales.

The feasibility study revealed high GP referral rates for women, men and children and showed that primary care is well-placed to provide a pathway for specialist support to all patients affected by domestic violence. The study demonstrated health and quality of life benefits for men and children supported by IRIS+. Our cost-effectiveness feasibility model indicated that IRIS+ is likely to be cost-effective or even cost-saving, but pointed out the need for larger scale research to establish the programme’s effectiveness and actual cost-effectiveness and to inform commissioning decisions.

Journey to full clinical trial

Our first meeting two and a half years ago to discuss a possible grant application was prompted by a domestic abuse call commissioned by the NIHR Public Health Research Programme (PHR). Our team, forged between UK industry and academic (including University of Oxford) collaborators, was determined to put IRIS+ to a hard test and was keen to respond to the emerging scientific opportunity. A flurry of meetings with methodologists, patient and public involvement (PPI) groups, stakeholders, possible project partners and the PHR’s research support service followed. The proposal fast evolved to a large multicentre randomised controlled trial with economic and process evaluation. The increasing complexity kept adding to the costs, and further complicated our site requirements and partnership arrangements. Despite three months of hard work, the outline proposal wasn’t robust enough for submission. Given that domestic abuse remained a continuing area of research interest to the PHR Programme, after four more months of hard work, we submitted our Stage 1 proposal for the funding stream’s researcher-led call in July 2022.

Following successful shortlisting by the PHR Prioritisation Committee in September 2022 and then by the PHR Funding Committee in October 2022, we were invited to submit a full stage 2 application within six weeks. Our team was excellent, but the requirements were painstakingly substantial and the timeframe tight. There was a real commitment from all partners to this project now, we had all the expertise, we had firm support from the Bristol Trials Centre, and we were all passionate about this area of research. Inspired by our shared scientific curiosity, chased by the pressures of academia, and driven by a determination to make a difference to the lives of many, we submitted our Stage 2 grant application just before Christmas 2022.

“I am writing to inform you that your Stage 2 application was unsuccessful. However, the Funding Committee felt that your application has merit and would be willing to receive a revised Stage 2 application.”

Not the outcome we wanted, but the feedback was good and comments sought further clarification rather than questioning the importance or the design. Spring 2023 went by firming up the proposal and responding to panel queries. By then, we managed to push all our feasibility findings out to the public domain, which further strengthened the application.

On 4 July 2023, we received notification of the outcome. Scarred by the intensity of the previous year and a half, I needed a helping hand to open the heavy attachment. The green lights came with glowing feedback. We celebrated with Greek food before embarking on a busy ten months of pre-grant work.

Ingredients for success

Funder support

Our grant development work was enabled by the funder’s recognition of domestic violence as an issue of major strategic public health importance. This coincided with their ongoing commitment to fund large-scale evaluations on the benefits, costs and wider impacts of interventions that have the potential to improve the health of the public, reduce inequalities in health and have a national reach. Throughout the review process, PHR took on board issues around the complexity of the intervention. They understood how these complexities link with our methodological approach to capture distal health-related patient outcomes. They were fully supportive of our proposed model to mid-career research leadership and early career capacity building. They also recognised the key role of third sector organisations co-delivering the project.

Research alliances and co-production

Research on domestic abuse and trauma shows that people affected have a history of often not seeing the benefits of research nor the outcomes that matter to them. To ensure relevance and reach, our research group, over the years, has developed a strong portfolio of co-produced research with third sector service providers, service users, including domestic abuse victims/survivors, and the NHS. The IRIS+ trial proposal was built on these already well-established and trusted research partnerships with organisations committed to working together on the development, testing and implementation of cross-sectoral interventions promoting and improving the health, wellbeing and recovery of people affected by domestic violence.

It is only by these long-term relationships with partner organisations that we could quickly form meaningful collaborations in a new joint venture. Our industry partner, IRISi, a social enterprise and the pipeline for implementing our research, has been at the centre of this ongoing partnership. They will lead the intervention adaptation, implementation and any commissioning work. Our service delivery partners, Fortalice in England and Calan DVS in Wales were involved in the grant development process from the onset. They also enabled important connections with local commissioners. Fortalice and Calan DVS will deliver the intervention both in general practices and in the domestic abuse agencies and will support the research team with data collection. VOICES, a domestic abuse charity founded by survivors for survivors, created on-going dialogues between the research team and people with lived experience. Our public co-applicant will ensure that their perspectives, including those of young people, remain part of the project. Others, including Next Link and Mankind provided ongoing support for our PPI work and will continue to plug to their wider networks.

Pre-grant support from our local Integrated Care Board

Colleagues at our contracting organisation, the NHS Bristol, North Somerset and South Gloucestershire Integrated Care Board (BNSSG ICB) provided tremendous pre-grant support for the project. Since the NIHR had no provision to cover excess treatment costs, it was the research team’s responsibility, in conjunction with our service providers and their commissioners, to determine and secure all costs for the delivery of the intervention across our trial centres in England and Wales. Given the recent system changes, the complexity of the intervention funding landscape, and the unprecedented pressures on the NHS and local budgets, it took over a year for the BNSSG ICB team, together with our third sector partners, the University of Bristol and the Welsh Government, to secure the necessary funds for the intervention. This complicated work, on behalf of the University, was led by an experienced programme manager, funded by an external grant for one day a week for six months.

Pre-grant researcher capacity

Creating and funding additional capacity to support the application development (and setting-up activities during pre-grant phase) were key to take us to our starting line. Instrumentally, the BNSSG ICB Academic Career Award supported me to lead the grant development work. The award, set up in 2022, enables a non-core funded mid-career Bristol academic every year to dedicate time to grant development activities that support their career stability and to help reduce the pressures of short-term contracts. The award offered me exactly that opportunity and helped me to stay in job between grants.

Time, commitment and determination

While team expertise, strong existing collaborations and adequate capacity were key, we could not have done the development work any faster and without the remarkable commitment and determination of everyone involved. Given the trial’s complexity, allowing time for the process – measured in years rather than in weeks – was vital. Also crucial were robust academic support and mentoring structures and a supportive environment, provided by the Centre for Academic Primary Care (CAPC), the Bristol Trials Centre (BTC) and our wonderful knowledge hive and social anchor, the Bristol Domestic Violence/Abuse and Health Research Group (DVAHG).

Conclusion

With all of these ingredients in place as a bedrock from which to launch our new trial, I am almost as naively confident now, on day one, as I was two and a half years ago, that whatever the next 1,339 days bring, together and well-resourced, we are in a good place to start this challenging and important trial.

Further information

For more information about IRIS+, see the news story on the CAPC website or contact iris-plus-trial@bristol.ac.uk.

Disclaimer

The IRIS+ Trial (A primary care system-level training and support programme for the secondary prevention of domestic violence and abuse: a multicentre cluster randomised trial with economic and process evaluation) is funded by the NIHR Public Health Research Programme (NIHR153788). The views expressed are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care.

Help and support

If you have experienced domestic violence and abuse and would like support, you may find it helpful to contact one of the organisations listed below:

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