Quicker and slicker: new initiatives to improve clinical trial delivery
pharmafile | November 16, 2011 | Feature | Research and Development |
Faster study set-up times, reduced bureaucracy and timely patient recruitment – these things are central to the success of commercial clinical trials, and key to a thriving life-sciences industry here in the UK. During 2011, the National Institute for Health Research Clinical Research Network launched a number of new initiatives to support pharma companies and CROs in delivering research studies in the NHS. Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, examines these latest developments, and what they could mean for timely commercial study delivery.
Take a look at the government’s recent Plan for Growth, and it is immediately apparent that the life-sciences industry is right at the heart of political thinking about a healthy and diverse economy. This is good news, but of course these policies need to be translated into action on the ground, to help companies to deliver on their domestic clinical research ambitions. One of the organisations playing a key role in this practical delivery is the National Institute for Health Research Clinical Research Network.
The NIHR Clinical Research Network was set up by the Department of Health to help both academic and commercial researchers to deliver research in the NHS, in line with study timescales and patient recruitment targets. The support provided includes funding and training “front-line” staff (such as research nurses, and data professionals) to carry out trial activities, and practical help in identifying and recruiting NHS patients onto studies.
The Clinical Research Network is already well known by many of the major commercial companies, which have been using the Network’s “off-the-shelf” tools such as the standard Industry Costing Template to reduce the time taken to negotiate the cost of carrying out trials in the NHS, and the model Clinical Trial Agreement to speed up contracting between companies and NHS organisations. However, in recent months, a number of new developments have been launched that extend the support.
The first development is the Study Start-Up Route Map. Quite rightly, every study which takes place in the NHS needs the relevant approvals and permissions before the trial can commence. However, many life-sciences researchers have found it difficult to know who to go to for study initiation, what information is needed, and at what stage – which can slow down the process of getting a trial up and running. The Clinical Research Network put together the Study Start-Up Route Map as an easy-to-follow guide that shows what to do, and what support is available, to minimize delays in the start-up process. The Route Map was tested out at a recent meeting attended by more than 100 life-sciences research professionals, and received much positive feedback.
The Network has also introduced a number of performance management tools such as study milestone schedules and Red-Amber-Green reports that facilitate the early identification of any performance issues, so they can be resolved in a timely way – and that is just the start. We are also about to begin a major improvement programme, based around “lean” principles, that should see study start-up processes and the management of patient recruitment become more effective, and more efficient.
A further development involves the NIHR Clinical Research Network developing a number of “green shoots” sites – NHS Trusts that are new to commercial research, and keen to get involved with clinical trials sponsored and/or funded by life-sciences companies. Understandably companies often look to run studies in sites that they already know well, but this can lead to capacity issues in popular NHS Trusts. Recently we have developed a series of “heat spot” maps, which show the concentration of clinical trials in NHS Trusts in England, and also the places that are under-utilized. Our “green shoots” campaign will help to open up some of these under-utilized sites to industry, to extend overall access to patient populations, and maximize the opportunities for full recruitment to trials.”
Backing both of these developments is a final initiative – Network Champions. The Champions will be life-sciences company employees who receive special training to become “super-users” of the Clinical Research Network and its services, capable of guiding commercial colleagues on how to access the various support tools available. Whilst the first wave of Champions is likely to come from the major pharma companies, there are already plans to extend the Champions group further as the initiative develops. If the clinical research system is to work well, there needs to be a strong dialogue between the commercial research community, and the Clinical Research Network staff who are charged with supporting this activity. The Champions group will become in-house experts, helping others in their company to tap into the help that’s on offer. This group will also help us to shape new ideas about how to streamline systems and improve research delivery even further for the future.
For further information on the NIHR Clinical Research Network initiatives for industry, visit:www.supportmystudy.nihr.ac.uk
By Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network.
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