News with Views

Dragon Fires Business Support Warning

Entrepreneur and former Dragons’ Den star Doug Richard has called on the Government to “sweep clean” its entire range of business support and funding schemes.

In a damning new Entrepreneurs’ Manifesto released last week, Mr Richard claimed UK businesses were being stifled by a burden of regulations.

http://www.j4bcommunity.co.uk/Default.aspx?WCI=htmHome&WCU=CBC=View,DSCODE=J4BGRV,NEWSITEMID=39-N7758,SOURCE=NEWSL

Artificial Pancrease Hope for Children with Diabetes

Scientists in Cambridge have shown that an "artificial pancreas" can be used to regulate blood sugar in children with Type 1 diabetes.

A trial found that combining a "real time" sensor measuring glucose levels with a pump that delivers insulin can boost overnight blood sugar control.

Link to BBC article:� http://news.bbc.co.uk/1/hi/health/8498993.stm

Tony Davis of - MedilinkWM - 13:29:24pm Feb-11th Insulin pumps are often raised by industry to government as the best example of what’s wrong with the NHS’s  approach to the adoption of medical technology nInsulin pumps were tried and tested globally with huge amounts of UK and International data produced on their efficacy NICE reviewed all the evidence and concluded that they had a significant effect on the quality of healthcare and on the quality of life of the patients and sent a signal to the NHS to adopt the technology.nFor the reasons we can all guess at i.e. cost this guidance has largely been ignored resulting in the 3% UK usage compared to 20% USA statistic from Diabetes UK.

Patent Box Scheme – can you afford to wait?

Chancellor Alistair Darling introduced a ‘patent box’ scheme in his pre-budget report, dropping the rate of corporation tax to just 10 per cent for any income which stems from patents in the UK. Unfortunately it doesn’t begin until 2013.  What do you think? Will a change of government rule it out? Do we need to lobby again to ensure its survival after the election?

Les Farrington of - Binding Site - 14:29:18pm Feb-18th The introduction of the 10% Patent Box is welcome news for companies such as mine who are investing heavily in R&D. It also supports the concept of keeping the innovation in the UK. The only real concern we have about this scheme is waiting until 2011, especially after the successful drive of the Office of Life Science and their recent launch to deliver the blueprint- what’s the rational and where’s the investment short term?

Martin Levermore of - MDTI - 11:15:45am Feb-18th What about the small, innovative companies who struggle to have the resource to actually file patents? Couldn’t the Government also do something to support the patent application process, or is this only a bill for big industry?”

A Fair Trial in the UK

The cost per patient and the start-up and recruitment times have become higher in the UK than in many other countries. In order to meet budget and timeline, patients are increasingly being sought elsewhere. The statistics are stark: up to 25% of UK sites fail to recruit any patient1, UK contribution to global patient enrolment has reduced markedly over six years2 and there is the news that one major global pharmaceutical company has recently decided to downgrade the UK to being a ‘non-core’ country in terms of trials3.

For the manager of a large international trial, centres that fail to recruit at all represent a significant setback. They will already have required site approvals (and country approvals), site assessment for suitability, site initiation visits, site master file/documentation, drug supplies delivery, and an agreement with the pharmacists. Recruitment problems may further demand several encouragement visits and/or ultimately a country investigator meeting, followed by the inevitable close-down visit. Sites that include just one or two patients and then stop recruitment are often less effective statistically, as each site produces more variability into the trial.

Collectively these problems add up to a huge waste of resources – not to mention erosion of the timeline, as the deficit in patients needs to be made up later. Action is being taken at government and NHS level to reverse this trend. In May this year, the government’s response to the ‘Review and Refresh of Bioscience 2015’ report included a commitment to incorporating clinical research metrics – such as the number of patients recruited and the time taken for local research approval – in annual quality accounts produced by Trusts. There will also be an objective to double the number of patients participating in clinical trials over the next five years.

Regional initiatives are also important. For industry studies adopted into the NIHR research portfolio, the Northwest Exemplar Programme aims to demonstrate effective study set-up and delivery. The UK Clinical Research Collaboration has set up a number of clinical research networks designed to provide access to a large number of patients, including networks closely linked to the Northwest region. While it certainly makes sense to expand the number of potential patients available, experience indicates that this alone may not be enough to maximise recruitment.

In any trial there are the good recruiting centres and those that recruit one or no patients. How can it be that similarly sized sites, working with readily available and suitable trial subjects, exhibit such variable recruitment to clinical trials? In the main, this appears to reflect the organisational culture prevailing at a given site. The best sites have a culture of continually doing important trials, whether on behalf of industry or academia, and demonstrate a cluster of practices contributing to their effectiveness. Firstly, all staff are included – physicians, nurses and ward staff – and they understand what is being done and why. The trials are either sequential or, if run concurrently, do so with safeguards to ensure that they do not recruit the same patients. The protocol is carefully considered at the outset and queries dealt with at the time, which means there are no surprises later. Because all staff understand the rationale and protocol, appropriate staff can raise the issue of informed consent early – important in an acute study where a “consent window” is probable.

Further, pre-screening logs are enthusiastically kept in order to assess reasons for non-admission to the trial: these are checked later by the investigators to establish if they are making the right clinical predictions, with regard to inclusion/exclusion criteria. An important factor in acute trials is that on-call staff (covering a 24- hour, seven-day week) are involved in recruiting, rather than only research staff who may be working a 40-hour, Monday-Friday week. And equally important, once patients have been recruited their data is entered into the given data entry system promptly and accurately.

These, essentially, are the characteristics of effective trial sites that the UK must offer to be internationally competitive. Once trials go elsewhere it is easy to award future trials to the proven sites, so the UK needs to do even better than its rivals in order to reverse the trend. We now have good, well-thought-out initiatives at governmental and regional level, both current and developing, that are vital in promoting that shift. But local support for sites to improve trial approval timeline, culture and infrastructure may also play an important part in benefiting recruitment and trial completion. It is arguable that a pilot initiative to take that role is well worth considering as a component in the developing strategy.

1 Presentation by Dr Allison Jeynes-Ellis: ‘Clinical Research in the UK Today – a Brighter Future Beckons?’ (NIHR Clinical Research Network meeting 4.6 09) www.ukcrn.org.uk/index/.../01/.../AJE_clinical_research_June09.pdf
2 Centre for Medicines Research: global patient enrolment 2000 to 2006
3 Pharmafocus June 15, 2009: ‘Scaling up the UK’s Research Ambition’

Tony Davis of - MedilinkUK - 10:34:57am Feb-2nd MedilinkUK has long campaigned for better recruitment and reduction of cost by not applying the full economic cost of the NHS overhead and through its Clinical Trials Industry Special Interest Group which it runs on behalf of the medical Technologies and medicines Knowledge Transfer Network

Lord Butler comments on the Personal Care Bill

Britain's former top civil servant Lord Butler has warned that legislation on personal care risks being an example of "very bad legislation".

He told Today presenter John Humphrys that the legislation had been rushed through and that parliamentarians should not consider the bill until proper consultation had been completed.

http://news.bbc.co.uk/today/hi/today/newsid_8490000/8490671.stm