GSK: Committed to improving UK clinical research
pharmafile | October 6, 2009 | Feature | Research and Development | GSK, GlaxoSmithKline, NHS
GSK is the second biggest pharma company in the world, and Britain’s biggest homegrown firm in the sector. That means the company has always looked to the UK to conduct its clinical trials – but serious disincentives mean that conducting trials is increasingly difficult to justify.
In the UK, GSK has seen its patient numbers in trials fall by 63% between 2000 and 2006, making its contribution to the global group sink to an all time low.
And the trend is not specific to GSK – data shows for industry as a whole, the UK’s contribution of global clinical trials has plummeted from 6% in 2000 to 2% in 2007, with a large share going east to China and India.
GlaxoSmithKline’s UK medical director Pim Kon, has 15 years experience in the industry, and has never seen the UK’s clinical research environment so critical.
“We are getting to the stage now where it is going to be very difficult to defend conducting clinical trials in the UK. It’s a struggle when I stand up at our Europe clinical meetings and try and justify why I still have such a large team with this sort of contribution.”
So what has happened? Kon says complacency – and perhaps even arrogance – are to blame.
“I think we have been complacent in phase III trials. In the past when the emerging countries came on board, the view was that the quality is so good in the UK that they’re never going to be able to compete with us.
“But actually the quality [in Asia] is very good and their patient throughput is very high.”
The costs of trials are generally lower in emerging markets, and their treatment-naïve patient populations also make them more attractive. But the UK doesn’t help itself, says Kon. She points to other countries in Europe with similar costs and healthcare systems that are more competitive, such as Germany and France. GSK’s in-house statistics show the number of patients in the UK is now comparable to the Netherlands and Bulgaria, which have much smaller populations.
“The number is reducing significantly. If you look at the proportion of patients recruited by country, the UK generates just 3% of GSK’s total number of subjects recruited in Europe.
“If you compare that with the Netherlands – which is much smaller than the UK – they contribute 3% as well. That shows the UK is not being competitive.”
GSK UK downgraded
GSK has recently undertaken an efficiency exercise called ‘Footprint’ to reduce costs, reducing the number of countries it conducts trials in from 62 countries down to 40. The 40 countries still within the ‘Footprint’ are designated either ‘specialist’ or ‘generalist,’ and those left outside it will no longer conduct GSK trials at all.
Countries that are designated ‘specialist’ will have additional investment and will be approached first for clinical trials in that therapy area, on the understanding it enrols patients more effectively. If a ‘generalist,’ it may be approached as a secondary measure.
So how did the UK fare? It was labelled specialist in oncology only – one therapy area out of six – which compares with Germany and France, which are each specialist in all and four different areas respectively.
“The principle for GSK is that the UK is lagging well behind the other countries in our top five EU territories, which are Germany, UK, France, Italy and Spain.”
There is also a sense that the UK was selected into the Footprint due to GSK’s heritage, and sense of obligation to the country.
Pfizer, which is similar in scale to GSK but without its British roots, has recently cut its losses and abandoned in-house trials in the UK, declaring it a ‘non-core’ country for clinical research.
Kon says: “For my [overseas] colleagues there is that question – why are we still conducting trials in the UK? But I think they understand that we are a UK organisation, and we will be committed to conducting trials in the country in which we are based. That’s in contrast to other countries where they have pulled out completely.
“I don’t think it is a sense of obligation, but it is a sign of our commitment to being here. We are a UK company and we will do as much as we can to maintain that role for UK patients.”
But even though it remains in place, GSK UK’s research team has been diminished; the number of staff is now only 71, some of which are contractors.
“Yes, the number has certainly decreased. And we are having to constantly review it based on the data and productivity level at which the UK performs.”
But why is the UK’s record so poor? Longer lead times due to bureaucracy around the approval of trials between NHS Trusts and investigators is one factor, and low patient recruitment is another.
“Part of the reason is that we are slower to initiate the trials, slower to recruit patients, and we have more sites with one or no subjects.
“And potentially it could drop further. Sometimes you have a chicken and egg situation whereby if you’re not performing, they are not going to place trials. So you don’t get that opportunity to do so.”
Kon says efforts over the last few years by the DH and the National Institute for Health Research (NIHR) to cut red tape are to be applauded. But she says it is too early to gauge their success, and a lot more still needs to be done to increase patient participation in trials.
But it is not entirely for lack of trying. The government’s newly formed Office of Life Sciences (OLS) is trying to ensure Trusts deliver NHS patients for trials and help lead innovation, instead of hampering it.
In July this year the OLS released a ‘Blueprint’ which aims to return the UK to being a global leader in research by putting innovation at the heart of the NHS, and giving Trusts responsibility to participate.
Though a recent poll commissioned by the ABPI showed over half its members think it won’t make the difference needed, and the environment will deteriorate further in the next 12 months.
Kon harbours the same scepticism and says GSK had hoped the Blueprint would be a lot more prescriptive.
“I believe that the right principles were captured, but everybody knows the principles, and has for years.
“Everybody knows Trusts should take responsibility and accountability [for delivering patients], but there was no clear direction as to what would happen if they didn’t. So there was no clear incentive or disincentive within that Blueprint.”
GSK: new hope through transparency
But Kon still has some hope, and wants to work towards a better future. As a result GSK has recently taken a new approach that illustrates how desperate the situation is.
The company now goes to NHS trusts with its dwindling figures for patient participation in order to stress the importance of working together – something uncommon in an industry and never done before by GSK: “We are sharing some of this data with our clinical sites to say look, we are desperate to work with the UK and we are absolutely committed to doing that, but look at the numbers. Unless you help us it is going to be very difficult to justify conducting clinical trials in the UK.”
She sees it as a tripartite responsibility, split between the NIHR, the industry, and the NHS.
“If you show them these numbers, and nothing happens, then it would show they don’t care. But actually when they do see the numbers, they really do sit up and take stock,” says Pim.
“Most Trusts are surprised because at the moment they don’t understand, and you can’t blame them. People work in their own Trusts and they don’t see how others work and they don’t see how other countries work.”
Kon and the Department both regard North West England’s Strategic Health Authority as setting a good example for other UK regions. She says it is an innovative Trust that is willing to work with industry and understand the importance of clinical research. It is this ethic that needs to be transferred to other Trusts in order to make progress.
With its new transparency drive, GSK is also looking to bring about a positive attitude towards trials among patients, as well as doctors and trusts.
“The positive aspect of clinical trials, and the positive outputs of the contributions that people can make, I don’t think is fully understood by patients. And that is another area that we as industry, patient groups and certainly the government can help, to encourage people to participate.”
But there remains an underlying sense that the UK will not contend at the top again in phase III. “I think it would make a difference, I’m not sure it would be a significant difference. But every little bit helps.”
DR PIM KON
Dr Pim Kon, Vice President and Medical Director GSK UK, was a hospital physician specialist in respiratory for eight years prior to joining the pharmaceutical industry, where she has now worked for over fifteen years.
During this time she has worked in a number of major companies including Abbott, Aventis and Pfizer in diverse roles across areas such as pharmacovigilance, clinical research, medical affairs, chronic disease management and market access, both at UK and global level.
She is a Fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians and has completed an executive MBA from the London Business School.
Kon joined GSK two years ago as director of respiratory before being promoted to the role of medical director 18 months ago.
Related Content
GSK’s Exdensur receives MHRA approval for asthma and rhinosinusitis
GSK’s Exdensur (depemokimab), a twice-yearly biological medicine, has received approval from the UK Medicines and …
A community-first future: which pathways will get us there?
In the final Gateway to Local Adoption article of 2025, Visions4Health caught up with Julian …
The Pharma Files: with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust
Pharmafile chats with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust, about …
