Early clinical research activity in the UK has been on the decline since 2016, with 95 Phase I clinical trials initiated in 2018, compared with 117 in 2017 and 150 in 2016, a decrease of 37%. For Phase II and Phase III clinical trials, activity remains relatively unchanged, with a small decrease in Phase II clinical trials initiated in 2018 compared with 2017 (281 in 2017; 268 in 2018) and a small increase in Phase III clinical trials initiated in 2018, compared with 2017 (269 in 2017; 292 in 2018).
In addition to this, data from the MHRA gives an insight into the interest in conducting clinical research in the UK. The number of clinical trial applications received since 2016 has remained stable (Figure 2). In 2018, 798 commercial applications were received, comprising 131 Phase I, 630 Phase II/III and 37 Phase IV trial applications (Figure 3). Tracking trends in commercial applications, as further data is published by the MHRA, will help assess commercial interest in the UK clinical research environment over the coming years.
Furthermore, in 2018/19, the NIHR Clinical Research Network recruited 870,250 participants to over 6,100 clinical research studies and trials (3), in particular, succeeding in mobilising the patient and public community in areas such as mental health and dementia, through the NIHR’s Mental Health BioResource and the Join Dementia Research service (3). To further support recruitment to late-phase commercial research, the UK Government also announced the establishment of five Patient Recruitment Centres across England . This investment in late-phase infrastructure should bring new opportunities for commercial sponsors and help grow the UK’s Phase III research activity.
It is important to note that the data presented in this report shows the levels of research before the impact of COVID-19, which we know significantly impacted the research environment globally. In the UK, clinical research was proactively paused to help prioritise COVID-19 research and ensure optimal management of COVID-19 patients (13). Although a framework for restart of non-COVID-19 research has been issued in the UK (14), there is some evidence that restart has been faster and more successful in other countries, which as discussed later in this report.
Figure 1. Number of commercial clinical trials started in the UK, by year and phase (2012-2018)
Figure 2. Number of commercial clinical trial applications received by MHRA, by year (2013-2018)
Figure 3. Number of clinical trial applications received by MHRA in 2018, by phase and sponsor type