Janette Benaddi MICR CSci
Keywords
Challenges, Commercial research, Medical device research, Non-commercial research, R&D approval
Whether you are working with medicinal products, biopharmaceuticals, medical devices, cosmetics or nutritional products there are a number of themes that are common for all of us involved in clinical research. We need to obtain the necessary approvals in a timely manner and have access to appropriate patient populations. In my role as the Chair for ICR, I am fortunate to have the opportunity to attend many different meetings, mostly in the UK, which are related to improving the clinical research environment. I enjoy this immensely and think it is extremely important we have a voice at these events. It is impossible for me (or, indeed, anyone) to replicate the direct experience of all our members, not having worked in every sector. However, I try to understand the major issues affecting you and encourage you to become more involved yourself as opportunities arise for influencing the shape of clinical research.
It is always interesting to learn that the challenges we face are often similar despite our diverse therapeutic fields and specialisations. Of course, this depends rather on the position we have and our clinical research role. If you work in a hospital then recruitment targets, appropriate training and sufficient resource and finance might be important to you. If you work in a commercial company conducting trials, then set-up and recruitment might be the main challenges.
Having spoken with many members over the past few months and attended a number of events, it is clear that one of the main issues for commercial research is obtaining approvals in a timely fashion. It would seem that there have been vast improvements in obtaining regulatory and research ethics approvals for studies but there is still some way to go in terms of getting through the hospital research and development approval systems. This is an area on which the NIHR is concentrating and a number of working groups have recently been set up to address this, with the aim of standardising and improving the system. There are, of course, some excellent R&D departments in the UK who make role models on which to build. There are others who struggle through lack of resource, training or other contributing factors. Sometimes, delays in the approval process can be due to the applicants themselves not understanding the process or knowing where to go to gain permissions.
In non-commercial research there are other issues: skills shortages in operational areas, formal training in clinical research for medical staff and specifically understanding some of the differences in regulations for different types of products. For example, medical device clinical investigations do not fall under the EU clinical trials Directive (and its implementing legislation), which has implications for the way these studies are managed and conducted. Training staff at sites to understand different products and the different legislations that apply would also greatly help the commercial sector.
I recently attended a one-day event held to report the major results of a 2-year EPSRC-funded research project which sought to identify the key challenges for managing different models of clinical research in the UK. The study was conducted using a large survey of over 200 clinical trials that have recently been conducted in the UK, together with in-depth interviews with all of the major stakeholder types involved in clinical trials. The results reported on the strengths of UK clinical research base along with the challenges that are currently encountered when conducting commercial and non-commercial trials from perspectives of different stakeholders. It was clear from this event that in general the major challenges are recruitment, cost and timely hospital approvals.
What I have highlighted are mostly the struggles within the UK; in the following months, one of our Board of Directors who is our ‘voice for Europe’ will comment on the situations in other countries. In the meantime, we continue to try to manage the challenges we have and thank those of you who are involved in the many initiatives to improve the clinical research environment.
If you wish to share any of your challenges then please write to us via our Editor, Andrew Smith, who can ensure these are passed on to the relevant forum.
Janette Benaddi MICR CSci (janette@medvance.co.uk) is Chief Executive Officer of Medvance Ltd and Chair of The Institute of Clinical Research.