Members of the public along with a team of Leicester researchers have come together to co-produce an Inclusion Checklist for Clinical Research.
Hardeep Aujla, Robert Grant and Anab Hasan
Click here to view the checklist.
The checklist aims to ensure that health researchers use a structured, evidence-based approach to ensure inclusion of underserved communities within clinical trials.
The checklist was officially launched today (9 April) in London at the Royal College of Surgeons. It is hoped it will be adopted by the National Institute for Health and Care Research (NIHR) for all publicly funded clinical research.
Professor Gavin Murphy is an academic cardiac surgeon at the University of Leicester and is also British Heart Foundation Chair of Cardiac Surgery, who helped develop the checklist.
He said: “Over 50% of people in Leicester are non-white but in our local trials only 5% of participants are non-white. People from underserved groups suffer disproportionately from cardiovascular disease but are systematically under-represented in research – something which is evident across other medical trials. We hope to change this so that research trials are as inclusive as possible and can benefit everyone.”
Dr Maria Pufulete, from the University of Bristol, who led on the research said: “This newly created checklist will help to ensure that researchers undertaking any clinical trials have systematically done everything possible to include underrepresented communities within their studies.
“Although there are frameworks for this already, they don’t tend to be operational and are often difficult to interpret. What we’ve done, in co-operation with patient and community groups, is create a robust checklist for researchers, using a consensus methodology. It will enable them to see how representation has been achieved within their trials.
“We know that by widening participation research becomes more generalisable to the UK population, and in turn should generate results more rapidly as more and more communities become involved.”
Funding for the work came from Heart Research UK, the British Heart Foundation, and the NIHR.
Dr Sonya Babu-Narayan, Clinical Director at the British Heart Foundation and consultant cardiologist, said: “Currently, cardiovascular clinical trials are often not representative of the population living with the disease being studied. We at the BHF are proud to see our research community taking the initiative to develop tools that could help to address this ongoing global challenge.
“For research to discover tests and treatments that benefit all those that need them, participants must represent the relevant patient population. To achieve this, we need to ensure everyone is given the opportunity and support to take part, especially groups that have been underserved by research until now. We know that this checklist is an important step towards that goal.”
For more information and to view/download the checklist visit the webpage.