The first clinical trial which the St Richards cardiology team were involved in was the landmark Rita 3 study in 1997 which was funded by the British Heart Foundation with Dr Colin Reid and Dr Conrad Murphy as local investigators. As a result of RITA 3, most patients admitted with acute coronary syndrome are now routinely investigated by cardiac catheterisation. The team was then joined by Sally Moore, research nurse. Since then, the team has focused on delivering commercial clinical trials, with the earliest studies being CADET, ONTARGET and CHARISMA. Dr Yuk-ki Wong joined the team in 2003 and to date, almost 40 additional clinical trials have been completed. These studies investigated a number of important drugs that have been since approved by NICE including clopidogrel, ranolazine, alirocumab, ivabradine, rivaroxaban, ezetimibe, finerenone, bempedoic acid, apixaban, semaglutide and inclisiran.
In the UK, the number of patients enrolled onto commercially led trials supported by the NIHR dropped by 44% between 2017 and 2022 (the Lord O’Shaughnessy review) with an estimated loss in income of £360 million. However, during this period, cardiology research activity has increased considerably at St Richards and over the past few years, the department has been sought out by pharmaceutical companies to collaborate with their trials. This has led to a stable and expanding team with a focus on patient recruitment and retention as well as patient care. Sally Moore has been involved in every study since she joined the team, and has set the standard for recruitment and retention.
Patients may find it difficult to participate in clinical trials because of commitments such as a job or looking after relatives. By offering flexible appointment times including very first thing in the morning and by being helpful in other ways such as dropping off medication at home and liaising with GPs, cardiologists and other specialist cardiology nurses, many patients join our studies because of the high-quality care they receive. This ethic has been passed on to new members of the nursing team. Quite often, patients ask to be enrolled onto another study once their trial has completed and there are several patients who have been in multiple trials. As a reflection of our local population, patients are increasingly elderly with the oldest recruit being 92. Feedback indicates they feel well looked after during the many years they are in a trial and as a result of being in a trial, some feel this has led to earlier detection of serious incident disease, including cancers.
In the current research landscape, to be selected as a site for commercial studies, it is important to demonstrate good oversight by the principal investigator (PI) and to demonstrate a strong ability to recruit well. MRHA inspections are not known for their compliments, but our recent inspection was noticeable by a lack of any criticism of investigator oversight. Over the past few years, we have over recruited into trials. For instance, there were 39 patients in SELECT and 22 in OCEANIC. We were top recruiters nationally for ZEUS (26), FINEARTS (13) and STEP (5). Each recruited patient brings in average income of between £20,000-£30,000. Sally Moore is the national study coordinator for ZEUS and Yuk-ki Wong is the chief investigator for ATHENA and POSEIDON.
Apart from commercial studies, we are also involved with academic studies. An approximate £100,000 NIHR RISC grant was awarded to Yuk-ki Wong for the ALARM study. Dr Mark Tanner has been the principal investigator for pacing studies related to his links with the Hammersmith Hospital. We have collaborated on several studies with Oxford University.
Nowadays, clinical trials can be quite complex and there may be a need for imaging and other investigations. In particular, we are grateful for the help received from Mr Edward Caswell, consultant ophthalmologist and vitreoretinal surgeon and Mr Masoud Teimory and their teams. We are also grateful to Dr Kate Shipman, consultant chemical pathologist and her team for their help with recruitment and for the help from Cardiac Investigations and Dr Hatef Mansoubi.