Any potential medicine has to undergo extensive studies in humans to demonstrate its safety profile and efficacy before it can be licensed for use in the UK. Companies will work with physician researchers to conduct the research with them to a specific plan (the study protocol). Often these studies will be held in several countries around the world simultaneously to collectively provide an evidence base for the medicine.
From start to finish, the clinical development phase takes an average of 6 to 7 years, and historically we have seen less than 12% of candidate medicines that enter clinical testing (at Phase I) make it to approval, although data presented later in this chapter show a lower likelihood (7%) which may reflect a difference in estimation. The 12% estimation is a significant decline since previous analysis a decade ago; which reflects both the significant scientific challenges that face innovation in medicines today as well as growing complexity in clinical design itself.
Research into the impact of the National Institute for Health Research (NIHR) Clinical Research Network shows that, for commercial studies, NHS Trusts receive an average of £6,658 in revenue from sponsor companies, and a medicinal cost saving of £5,250 per patient recruited to each clinical study. This provided £176 million of commercial income and £16 million of medicinal cost savings for 2014-2015.
Clinical research is important to countries as a measure of the translational capacity of a healthcare system to bring concepts for new medicinal treatments into care. In the UK, the health research authorities in England, Scotland, Wales and Northern Ireland have been working to improve the environment and procedures for conducting clinical research, and progress is being made.
For the first year, we have rebased our analysis of UK competitiveness in pharmaceuticals and included a different mix of countries. This includes our estimate of the number of trials initiated by year, by phase, by country and by therapeutic area.