Blog Archive

Natalie Goulden, GM CLRN Programme Manager, attended this year’s NHS R&D Forum, titled ‘Prospering in the evolving NHS Landscape’. Here is her review of the event.

The first day of the meeting was focused on presentations from keynote speakers.

The opening presentation was from Clare Morgan, Performance and Industry Director at the NIHR Clinical Research Network. Her focus was on stakeholders working in partnership to provide a seamless and efficient service for researchers and funders that is entirely standardised and consistent. Clare presented updates from the Service Improvement Work that is taking place and reminded delegates that the ability of NHS Trusts and Networks to attract future funding and research will be reliant on high quality performance, with recruitment to time and target, and a positive and flexible approach to service improvement.

The most talked about presentation of the afternoon was given by Adrienne Clarke, Oncology Clinical Team Manager for GSK UK. Adrienne was speaking on behalf of the ABPI Clinical Research Expert Network. She presented a very interesting overview of the challenges facing the life sciences industry, particularly in identifying new targets for drugs. Adrienne moved on to explore how the NHS and the life sciences industry can work in partnership to ensure studies are brought to the UK and delivered to time and target. Adrienne also spoke about maintaining quality standards, which can be challenging with highly complex studies that are being delivered under time pressures.

The final presentation on the first day was from Louise Wood, Deputy Director/Head of NHS Research Infrastructure and Growth in the R&D Directorate of the Department of Health. Louise presented an overview of the contribution that the NHS can play in enabling the UK to be a world-leader for life science investment, building on the Government’s strategy for UK life sciences. There was a particular focus on the need for strong links between the NHS, academia and the life sciences industry, building on the original Translational Research Partnerships. Louise also introduced the concept of Academic Health Science Networks to cover the whole of the country, to drive the uptake of research innovations and results.

Other presentations focused on the changes being made to the regulatory environment in the UK focusing on the MHRA risk proportionate approach, and on the changes resulting from the creation of the Health Research Authority on 1 December 2011. Electronic submission (e-submission) for MHRA and NRES approvals will be implemented from the summer of 2012 as part of a move towards a unified, entirely electronic, approvals process for NHS research in the UK.

The second day of the Forum centred on professional development workshops that covered a range of topics. The workshops allowed delegates to network and share their experiences, focusing on solutions rather than problems.

The overwhelming theme that came across from the Forum was that while it is a time of huge change in the NHS it is also a time of enormous opportunity, with research having a higher priority within the NHS than ever before.

This year’s NHS R&D Forum took place in Birmingham on 28 and 29 May with over 400 delegates attending from across the UK.

The NHS R&D Forum is an independent body, open to all those who are interested in NHS R&D, offering guidance, education and professional development opportunities, and representing the interests and views of R&D staff. Each year an R&D Management Forum, focusing on key issues for R&D staff, and offering the opportunity to participate in professional development workshops.

Craig Johnson, GM CLRN’s Data and Information Manager, looks at the improvements GM CLRN has made on reporting recruitment to clinical trials.

Did you know that CLRNs are performance managed on how complete the recruitment upload for our trials is on the Green Report?

The Green Report measures how complete the recruitment and trial information is on the NIHR Portfolio for CCRN-led studies running in each CLRN. It excludes any topic-led or commercially-sponsored studies.

It is based on the total number of studies that have uploaded recruitment data over a specified period (it should also include studies with ‘zero’ recruitment to date). The Green Report helps both us and the CRN Co-ordinating Centre keep track of how our studies are performing, which are open or closed, and those that have had amendments made. As with other areas of our performance, the CLRN is ‘RAG rated’ on our Green Report performance.

What is a RAG rating?
A RAG rating means that our performance within that area is either red, amber or green, depending on how well we are doing compared to our performance indicator. The different colours relate to different performance, so:

• <80% - Red is vastly underperforming compared to time and target
• <95% - Amber needs some improvement to meet time and target
• >= 95% - Green is performing to or above time and target.

Obviously our aim is to be green for all our performance ratings.

Improving our performance
In September 2011, we were at just 77% completeness, which rated as red and was an issue for us that we really needed to improve. We put a lot of work in over the last eight months and now on the 161 studies that we are currently being measured on, we are reporting 94% completeness. This is an amber rating and only one per cent from a green rating.

How did we achieve this improvement?
In order to improve our performance, we worked with both researchers and the UK CRN portfolio team to find out what issues were affecting our performance. What we found was:

• Many studies were incorrectly recorded on the NIHR Portfolio
• The status of many studies was incorrect. Some were reporting being ‘open’ when they had actually ‘closed’ and vice versa.

At some point research teams had not updated the Portfolio team on changes to their trial status. This has the knock-on effect of lowering GM CLRN’s RAG rating for this report. Once we knew what the situation was, we could work on improving it.

Fixing the problem
After a lot of detective work, we established that the main issue affecting study status was people not communicating changes to their trials. Where there were inconsistencies regarding Portfolio study status, I contacted each of the research teams involved to find out the status of the trial and get the latest information. Then I was able to update the Portfolio team.

In other instances, a study had requested an extension to its timeline, but hadn’t told the Portfolio team. As an extension requires documented evidence (such as ethical approval or funding confirmation) it takes time to obtain so changes the status of a trial.

Now that we’re up-to-date we’ve put processes in place to better manage these changes in the future and we can already see the difference they are making in the improvement in our RAG rating. However, we’re not quite green rated yet, so we now continually remind our research teams of the need to upload recruitment at least on a monthly basis, if not more often. Also, if there are any changes regarding their study status then they need to inform the UK CRN Portfolio team or GM CLRN immediately.

When a new CCRN study goes live on the Portfolio the Recruitment Data Contact (RDC), who is nominated by the Chief Investigator of the study, receives a data package by email from the UKCRN CC with details regarding the recruitment upload process. We are also copied into this email which includes my contact details at the bottom so the RDC can contact us with any queries regarding the upload process.

Additionally, we now send a courtesy email to the RDC just to touch base and remind them that we are here to help in any way we can. I feel this helps to break the ice with regards improving communication and lets the RDC know that we can help should they have any problems at all. This is helping to bridge that gap between the research teams and us as a Network and generate awareness regarding our local availability.

I also send data snapshots from the Green Report to study team co-ordinators that are relevant to their particular Specialty Group. These people are on the ground and have daily contact with the research teams so it gives them an idea of the overall performance regarding recruitment upload and any issues that may be holding things up.

By doing this we can all contribute to keeping the information as up-to-date and accurate as possible for any CCRN Portfolio studies that Greater Manchester are taking part in and in turn improve our performance.

Joyce Akeya Mensah, a Stroke Research Specialist Nurse Research at Tameside Hospital NHS Foundation Trust, tells us what one District General Hospital is doing to increase the number of NIHR Portfolio studies at the Trust.

Research provides essential evidence to convince health service providers to improve the services they offer and give better care to patients who have suffered from a stroke.

Through research we can learn about how stroke may be prevented so that the number of people having a stroke is reduced and how recovery can be improved for patients who have already suffered from stroke.

Research plays an essential part in the development of better care for patients in any situation. It is the way forward to improve practice, become more efficient and productive with patient care.

My job at Tameside involves co-ordinating all the studies taking place on the Stroke Ward, setting up the feasibility to see whether or not we have the capacity to run a study here and getting the studies up and running. One of my main challenges is encouraging nursing staff to get more research active. With increasing workloads, they face a lot of constraints on their time and often are not able to dedicate themselves to the additional work involved in research participation.

Championing research can be challenging but is always fulfilling. I know the value of research and how it can help improve medication and increase our understanding of conditions so we can improve and develop the care we give our patients. My aim is to encourage more research throughout the Trust and encourage other departments to get involved in studies. I have started running research training sessions on the stroke wards to try and raise awareness of research trials taking place and encourage nurses to take part.

Currently we are coming to the end of the MAESTRO Study which is all about encouraging patients to do more self-directed exercises, in addition to physiotherapy to see if it helps their recovery.

We have a few more studies which we hope to start in the next few months, these include the DARS study which is another rehabilitation study and involves giving patients medication an hour before rehab to see if it helps the recovery process. Then we’ve got the TARDIS study which looks at using a combination of antiplatelet drugs to reduce the risk of a further stroke by making platelets less sticky and preventing blood vessels from becoming blocked up.

Joyce is a Research Nurse within the NIHR North West Stroke Research Network team. She works part time at Tameside and part time at Manchester Royal Infirmary. The North West Stroke Research Network supports research to make patients, and the NHS, better.

Paul Thorpe, Head of Communications, tells us what GM CLRN is doing with its partners to ensure patients are at the heart of our work.

We are committed to involving patients, carers and members of the public in all stages of our research to make sure that research is relevant to those that matter most, the patients.

We’ve always looked at how we ensure as many people in Manchester as possible are involved with research. With projects such as Help Diabeates, we’ve helped to lead the way in innovative recruitment to research.

This year, we have a number of projects planned, from events that involve the 2012 Olympics, to the second Manchester Academic Health Science Centre’s Great Manchester Health Experiment, which this year is looking at diabetes research.

Our partner NHS organisations are also busy involving people with research. At Salford Royal NHS Foundation Trust, they have recently embarked on the Salford Citizen Scientist project, which is an exciting new initiative to build a large cohort of people who have asked to know more about research and to take part when something suitable for them is available. Greater Manchester West NHS Foundation Trust has also recently launched FAIR (Free Access to Involvement in Research) – its own new approach is linking service users interested with taking part in research with researchers. If this approach is successful, we’ll look at how we can roll this out to other Mental Health Trusts.

So you can keep track of all this work, we’re bringing it together into a Patient and Public Involvement area of our website. We’ll be developing this area over the next 12 months so you can keep easily keep track of our work.

Natasha Carrick (pictured right), Communications Manager for the Dementias & Neurodegenerative Diseases Research Network (DeNDRoN) shares a new toolkit developed to help researchers carry out more studies with residents in care homes.

“Dementia is a growing problem for the NHS and around 250,000 people who live in care homes have dementia. A recent report from the Ministerial Advisory Group for Dementia Research (MAGDR) recognised that we need to increase the amount of research to improve the quality of life for people with dementia. With so many people living in care homes, but relatively little research evidence from them, it was recognized that more research was needed to close this gap.

“Care homes provide a huge opportunity for us to develop research, especially with an ageing population. Until recently there has only been a small amount of research evidence on what works to improve the quality of care staff provide and the quality of life for residents in care homes. This may have been because people incorrectly assumed that care homes have nothing to offer or that it is too difficult to engage them in a meaningful way.

“To encourage more research in care homes, Dementia & Neurodegenerative Diseases Research Network (DeNDRoN) has developed the Enabling Research in Care Homes (ENRICH) toolkit which has so far proved a very successful aid for researchers wanting to set up studies.

“The toolkit is web-based and provides information on funding arrangements for research in care homes, as well as useful resources and guidance on best practice for researchers. It includes information on preparing and carrying out studies for staff, patients and families. ENRICH has been developed to help researchers understand the complexities of conducting research in a care home with advice from experts in the field. Whilst the website focuses on research in dementia, the principles for carrying out research in care homes are valuable to all areas of health research.

“ENRICH hasn’t just been designed for researchers, it can be used by care home staff and residents, as well as carers to find out more about the different types of research and the different ways in which they can get involved, how they can prepare for it, and what the benefits will be.

“There are also a number of detailed case studies that have been specifically developed to demonstrate some of the practicalities and benefits of conducting research.

"The NIHR Clinical Research Networks are here to provide the infrastructure to allow access to high-quality research. Opening up more care homes to research increases access to new and better treatments and care."

If you want to get involved in research or be a part of the network of ‘research ready’ care homes please email DeNDRoN at and visit the ENRICH Toolkit website at www.dendron.org.uk/enrich.

The Pennine Acute Hospitals NHS Trust is the largest Trust in Greater Manchester and has successfully increased the amount of research it carries out over the last two years. With over 50 NIHR Portfolio research studies currently active in cancer research, nurses and consultants are keen to develop this further for the benefit of NHS patients. Steve Woby (pictured right), Head of Research and Development, shares his experience of helping to grow research at the Trust.

“At the Pennine Acute Hospitals it has been important for us to boost the amount of research trials our patients take part in. We want to contribute to some of the ground breaking studies taking place in the country today – not only to benefit our patients but also to help improve the situation of others.

“We started working more closely with GM CLRN two years ago to find out the types of cancer trials taking place in the UK and identify how Pennine Acute could get involved. Initially we were particularly keen to open those studies that demonstrated the greatest recruitment potential. Once we’d established that it was feasible to carry out quite a number of these trials in our hospitals we were able to set up the studies quickly and recruit patients onto them fairly easily.

“We now have a very proactive and driven team of research nurses and trial administrators here who are constantly working with their consultant colleagues to identify new studies that we could open within our Trust. Our patients frequently tell us what a positive experience taking part in a trial has been.

“Cancer research is now a very big part of our Trust; we have over 1000 patients across our sites voluntarily taking part in cancer research. Compare this with three years ago when we didn’t have 100 and you can see the improvements that we’ve made. We currently have nine dedicated cancer research nurses working across all four hospital sites which has made a real difference to the types of studies we can support. It has meant that we can now take on more specialised and complex studies across a range of tumour groups.

“Often, recruiting patients to trials within the required time can be challenging. Problems with resourcing can have an effect on how quickly we are able to recruit patients on to trials. To manage this we’ve set up monthly reviews within the research team, where we identify any issues concerned with particular studies and assess projected targets for recruitment. For example, if there is a study we are struggling to recruit to, we will screen all the relevant clinics at all our hospitals, liaise with the doctors and nurses, make them aware of the study and see if they can identify any patients who might be eligible for the study. This direct communication with the clinical care team has proved a very successful way of ensuring that we meet recruitment targets.

"We are keen to open up studies into new specialities. For example, last year we opened some gynaecology studies at Rochdale Infirmary. This provided some of our Rochdale patients with the opportunity to participate in high quality cancer research.

“With support from the CLRN we’ve also recruited a research nurse to support colorectal research, and we are now one of the top recruiting sites for an academic study into the recovery of patients following primary treatment of colorectal cancer.

“Pennine Acute’s hospitals cover some of the most deprived areas of the country with the some of the worst health outcomes so these are people who could benefit the most from research. We feel that as a Trust, this is only the beginning and we’ve much more room for growth. Clinical research provides invaluable information about a range of issues experienced by patients, from the effects of treatments on their lifestyle to their responses to certain drugs and their rate of recovery as a result of different treatments. For the future we intend to expand our research capabilities even more by doing more research into other diseases as well as more specialised cancers.”

Aaron Gow, Communications Manager, talks us through the new Greater Manchester Research Map.

While Greater Manchester might be at the centre of our little piece of the universe, it still surprises me that some people don’t know where in England it is. What can be a little more difficult to visualise is the number and location of all the NHS sites and organisations that GM CLRN supports to carry out health research.

With this in mind, we’ve developed The Greater Manchester Research Map of all our Primary Care Partner Sites, NHS Organisations, NIHR Local Research Networks, and other research facilities in the area.

We’ve started by bringing together information from all organisations into one place so anyone who we work with or is interested can see it.

If you’ve used a Google Map before it should be quite intuitive to use but if not there is a brief ‘how to’ guide at the bottom. Currently the categories are searchable by:

• GM CLRN Primary Care Partner Sites – these are our GP partners who receive funding from us to carry out research within Primary Care
• NHS Organisations – these are all our Partner Trusts that we work with. We had tried to separate this into types of organisations, such as Acute Trusts, Mental Health Trusts, etc but the types of care NHS Trusts provide is changing and it makes it difficult to categorise in this way
• NIHR Local Research Network – these are the head offices of the various local research networks in Greater Manchester.
• Research facility – these are a number of other research facilities in Greater Manchester

The map is very much in its first stages and we have ideas about how we would like to develop it and already had people asking for similar for their organisations. We also want to hear your feedback about the information we currently display and what you would like to see in the future. Feel free to post in the comments section below.

How it works
Clicking on the tabs just above the map will show only places in that category, or a selection if you’ve clicked more than one tab. You can toggle the categories by clicking more than once. If you click the ‘All’ tab it will show all the markers from all the categories.

Clicking directly on any of the markers will bring up more details about that site .

To the right of the map is a scrollable list of the various sites. If you click on any of the tabs it will bring up more information on that organisation. You can also zoom in and out of the map with the scale tool on the left of the map or move the map around by left-clicking on the map (away from one of the places ‘pins’).

Natalie Goulden, Programme Manager at Greater Manchester Comprehensive Local Research Network (GM CLRN), explains how we the NIHR Clinical Research Network can help commercial partners in feasibility.

There should be no room for guess work in the set-up of commercial research studies. They usually need to be set-up quickly, have rigid recruitment targets and short recruitment windows.

The GM CLRN team spends a great deal of time on feasibility, and not a meeting goes by without it being mentioned. But why is it so important?

NIHR Clinical Research Network (CRN) feasibility ensures that studies are only set up at sites that have the right facilities and can recruit the patient numbers required. It takes account of other studies that are taking place, the track record of the investigator, staff available to support the study, and any special equipment or facilities that are required.
However, the way pharmaceutical companies approach finding sites for studies hasn’t been particularly evidence-based in the past. Sites have been selected because the investigator is well known, or the company have worked with them before – regardless of past performance or ability to deliver the proposed study. Sometimes companies end up approaching every possible site in the country.

Network feasibility takes the guess work out of study set-up for sponsors. Rather than approaching sites at random, or only going back to sites they have worked with before, sponsors are able to rely on CRN staff, who have specialist local knowledge and relationships with research teams, to ensure that the right sites are put forward for studies.
When a company approaches the Networks about conducting a commercial study, rapid national feasibility is carried out to ensure that the study is compatible with current clinical care in the UK and can be carried out within the NHS. Once confirmation has been received that the study can be delivered in the UK, the process of identifying local sites begins.

The Industry Team at GM CLRN coordinate the feasibility process for Greater Manchester, working closely with the leads of our Local Specialty Groups to ensure studies are matched with sites and investigators who have the interest, capability and capacity to carry them out.

Expressions of Interest (EOIs) are completed by Investigators (in collaboration with the Industry Team) and provide information on projected recruitment numbers, as well as any additional resources that may be required. The aim in Greater Manchester is for these forms to be circulated, completed and returned to the sponsor in five working days. The sponsor will then decide which sites they are interested in and begin site selection visits, which can go into a much greater level and detail. Whenever possible, a member of the Industry Team will attend these visits, to provide Network input and assess any resource issues.

Since April 2011, we have used this system on the 62 studies that we have performed Network Feasibility for. As these studies open to recruitment we will compare their performance with the original feasibility that was carried out. This is so we can see how our feasibility can be improved in the future and ensure commercial studies are being placed with sites and investigators that can deliver to time and to target.

Natalie Goulden is the Programme Manager for Greater Manchester CLRN, where she leads the industry and primary care team. Her role focuses on developing a strong infrastructure to support the delivery of commercial research, and on building long-term and effective partnerships with industry.

Prof Christi Deaton, GM CLRN Cardiovascular Theme lead, shares her experiences and achievements to reach the role.

“Evidence-based practice is a professional responsibility for all clinicians and we owe it to our patients to practice according to the best evidence that we have. Research activities, such as reading one paper, leading a journal club, reviewing evidence for practice, designing and conducting a study, collecting and analysing data, can be personally satisfying and challenging. It can add another dimension to your work, and potentially lead to other opportunities, regardless of your role.

"As a nurse, midwife or allied health professional, becoming involved in research can start with reading papers and questioning practice and the evidence base for what you're doing. Across all Trusts investigators and research nurses are usually keen to talk about the studies they’re currently carrying out. If you are serious about research, then education is the best option, especially the MRes, MPhil and PhD programmes.

“As Professor of Nursing at Central Manchester University Hospitals NHS Foundation Trust (CMFT), I work with nursing, midwifery and allied professional staff to build research capacity and capability.

“My research activities include everything from reading and discussing a specific study to building a programme of research that is externally funded. At CMFT we have a nursing administration that really values research and wants nurses, midwives and allied health professionals to contribute to the research mission of the Trust. We want to develop a 'research culture', where practice is questioned and evidence sought for best practice, and where research activities are seen as an integral part of practice, not as something additional.

“Like many nurses I spent many years in clinical practice before turning to a research career, but I was always interested in research. When I was studying, I wanted to be a scientist, although at that time I was particularly inspired by Jane Goodall and the work she did studying chimpanzees. I think that curiosity and the desire to understand 'why' and 'how' has stayed with me throughout my nursing career and that's what led me to research. I like asking questions and thinking about what we know and don't know, and then developing a study to hopefully provide some answers while stimulating other questions.

“As you won’t be able to tell from this blog, but you would be able to tell if you heard me, I am an American and the educational system is different there. I started my career as a registered nurse after a two-year associate degree programme and didn't go back for my baccalaureate degree until seven years later. I worked several years in a very small – 50 bed – rural hospital, where the nurses had to take on a lot of responsibility because there was no one else around. You couldn't specialise, but it was the cardiac patients that had the biggest impact on me. I started practice before thrombolytic therapy so there was little that we could do when patients had a myocardial infarction (MI) except to try and reduce myocardial oxygen consumption and increase collateral flow. I remember our excitement (and some scepticism) when a cardiologist from the nearest tertiary centre came to talk to us about transferring patients for streptokinase infusion into the coronary artery. I decided that I wanted to work somewhere that was at the cutting edge of practice and to continue my education. So I moved to Atlanta and began work in the coronary intensive care unit of a university-affiliated hospital.

“We were involved in the early Thrombolysis in Myocardial Infarction (TIMI) trials, and a number of other clinical studies. I went back to university for a baccalaureate degree and then a Master's degree. I enjoyed my research courses and knew that I wanted to combine research with practice.

“After that, I led a group reviewing the evidence for best practice for hemodynamic monitoring as we had different protocols and practices in each ICU. The use of research (much of it done by nurses) to improve our practice was very satisfying. My first research grant with some nursing colleagues was $250 (about £125); we conducted a randomised study on teaching a relaxation technique to patients prior to cardiac catheterisation. We found that patients randomised to relaxation-therapy received less sedation in the laboratory after controlling for weight.

“I continued to work clinically when I went back for my PhD and a year after I finished I took a post as the coordinator of outcomes research for the University cardiac service. Two years later I joined the faculty at the School of Nursing at the University. I have been lucky to have some wonderful and very generous research mentors, and to work with inter-disciplinary groups.

“I came to Manchester as a senior research fellow in 2003, and became Professor of Nursing about nine months later. To become a professor you need to develop a programme of scholarly work demonstrated by research and publications. Having mentors and good people to work with is essential!

“I’ll be honest, besides its reputation for wet weather, I didn't know much about Manchester until I moved here, but it is a vibrant city that has changed greatly from its industrial beginning. It's also surrounded by some of the most beautiful areas in the UK. I was attracted to CMFT for its outstanding research environment and high quality care and I already knew many people here when I took the position, and thought that I could continue to build on my collaboration with clinicians at CMFT. It's also exciting that nursing and allied professional research is so well supported by the nursing administration and the Biomedical Research Centre.

“As a researcher, you are always aware of the tension between the need to deliver the clinical service and the time required for research activities: that's a difficulty everyone struggles with. There are no easy answers but should always find time to do the activities that we value. If we value research, then we have to make the commitment to make time, while balancing the needs of the clinical service. It does require some dedicated or protected time for research and the commitment to use that time, rather than catching up on something else. There are always demands on time and too many things that need to be done. Research has to be a priority during non-clinical time. It also requires support from the environment and it helps to have a community or network of others who are also struggling with the same issues. Research is part of practice after all, and there should be a strong relationship between practice and research.”

Prof Tony Morrison, the new joint GM CLRN Mental Health Theme lead with responsibility for psychological research, explains how involving service users is vital for both researchers and patients.

“Mental health research has a number of specific issues which need to be considered in order to ensure benefit for patients, the NHS and researchers.

“As clinical researchers, it’s vital that we strike a balance between delivering care for people within very busy services and embedding and integrating research into these services. We also need to consider what research is of most benefit for service users as well as what is of interest to researchers.

“One aspect of mental health care that is perhaps different to other areas of health care is that treatment for patients with mental health problems is, at times, against the will of the patient. For instance, if you present at A&E with a broken limb then both you and your physician have a shared goal to make you better. But if you have psychological symptoms such as hearing voices or believing things that other people don’t believe, but you’re perfectly happy in hearing or believing them, it might not be a problem for you but it might be for those around you. So as researchers we need to consider the needs of everyone.

“Though service user involvement is vital in all health research, I believe this is particularly so in mental health, and especially in the more severe end of psychosis that I see. It’s vital from a research point of view that we involve patients in the research process, to ensure it makes an improvement to people’s care.

“Within my own area of research I’ve been very keen on service user involvement in research wherever possible. So within our own services’ research team we have several employees who have previously been or are currently service users who work in a variety of ways within our team – for instance one of these people is now studying for a PhD which I now supervise. This helps to ensure the research we are doing is relevant to patients.”

Prof Morrison is a professor of Clinical Psychology at the University of Manchester and works clinically for the Greater Manchester West Mental Health NHS Foundation Trust.

Dr Fiona Lecky (pictured), lead for the Emergency Medicine and Critical Care Local Specialty Group (LSG) provides an introduction to one of our newest teams.

“We got up and running in January 2011 following a successful application to the NIHR contingency fund.

“Our first area of work we’ve carried out is to see what was already happening across Greater Manchester within Emergency Medicine and Critical Care research. We found that there are pockets of research happening across a number of Trusts in the region in and we’ve started to bring together our local PIs to see what extra support we can offer.

“Because of the nature of emergency medicine, there are a number of issues around recruiting patients to trials that must first be overcome. Depending on the trial and the patient’s symptoms when they arrive in the emergency room, consent can be difficult. Also, the recruitment window is often very short and then follow-up can be tricky as the patient can end up in any area of the hospital. It can also be difficult for staff – who are in a very busy and time-sensitive environment – to spend 30 minutes or more explaining a trial to a patient. So we’re aiming to use our GM CLRN funding to provide a core of dedicated staff who are funded or GCP trained.

“Currently we only have academic studies on our portfolio but we have a number of commercial studies that are in the pipeline. In the future I see this area expanding as we have more support across Greater Manchester sites. Collectively, these sites must have over a million people visiting them each year so we have a massive potential for increasing our recruitment.”

Dr Fiona Lecky is a Senior Lecturer in Emergency Medicine at the University of Manchester and Honorary Consultant at Salford Royal NHS Foundation. For more information Fiona can be contacted via email.

Written by Prof Nigel Bundred (pictured), GM CLRN Cancer Local Specialty Group and Clinical Lead for the Greater Manchester and Cheshire Cancer Research Network.

Last year – April 2010 to March 2011 – was an excellent year for the Greater Manchester & Cheshire Cancer Research Network (GMCCRN) as it was our most successful yet in terms of recruitment to clinical trials and overall performance.

During this time all 12 of the Acute Trusts that we support recruited 10% of their new cancer patient population into National Cancer Research Network studies. On top of that, eight of those Trusts also succeeding in recruiting over 7.5% of their total population into randomised controlled trials.

Of course, this increase in recruitment means that more patients are accessing new and novel cancer treatments or procedures and I’d like to thank all the patients who agreed to take part in trials. Without patients agreeing to take part in clinical trials, at what is obviously a difficult time for them, then we wouldn’t be able to achieve these results and develop cancer services and treatments further.

As well as patients, I’d also like to thank the 12 hospital trusts that we work with for making this year so successful. By working with all of the Trusts in our area we’re ensuring ‘equity of access’. This official-sounding term means that we’re giving every patient the same access to clinical trials, regardless of where they are treated, whether in a world-renowned centre such as The Christie or at any of the District General Hospitals across the region.

How do we measure success?
As a Cancer Research Network (CRN), our success is measured against the other 31 CRNs and this year we were the top performing CRN in the UK. For three of the four indicators used to measure the performance of CRNs, we were top and in the final category we were second. This means, in 2010-11, GMCCRN recruited:

• The highest percentage of its cancer patient population into randomised controlled trials
• The most cancer patients into NIHR Portfolio adopted commercial trials
• The most participants into cancer and cancer-prevention studies
• And the second highest percentage of its cancer patient population into all types of studies.
  

However, such a successful year doesn’t mean we will be resting on our laurels. We’re always looking at ways to improve the amount of research into new treatments as well as working with new investigators at different sites.

We’ll be sharing some of the ways we’ve been able to achieve this success very soon.

GMCCRN is one of 32 Cancer Research Networks in the UK. It was established in 2003 to provide NHS organisations in the region with an infrastructure to support high quality cancer clinical trials. It has a remit to being benefit to patients, the public and the NHS by improving the speed, integration quality and inclusiveness of cancer research.

GM CCRN serves a population of 3.2 million people and covers 12 NHS Hospital Trusts.

Prof Nigel Bundred is Professor of Surgical Oncology and Consultant Surgeon based at the University Hospital of South Manchester NHS Foundation Trust as well as at the Christie Hospital NHS Foundation Trust, where he has a large clinical commitment to the Manchester Breast Service.

Written by Dr Pippa Tyrrell, Clinical Lead for the North West Stroke Research Network and GM CLRN Stroke lead.

Our North West Stroke Research Network meetings are excellent events for researchers, healthcare staff, patients and the public to come together to discuss the latest findings in studies and look at the priorities for the future.

This year’s event is titled ‘Advancing Stroke Care through Research’ and we’ll be discussing what future stroke research will be investigating and what the benefits could be for patients, during both the acute and rehabilitation stages of stroke.

Our keynote address this year is concentrating on the rehabilitation aspect, with Professor Derick Wade, consultant in neurological rehabilitation at the Nuffield Orthopaedic Centre, giving the address on: ‘What will research deliver for stroke rehabilitation in the next decade’?

Building on feedback from previous years, the first morning session has been designed to be of specific interest for health professionals, who will hear from Professor Sarah Tyson about the outcome measures used in stroke research, and from Professor Keith Muir about stem cell research with potential benefit to stroke survivors. The rest of the day has been designed primarily for lay people, especially stroke survivors and their carers, but the event is open all day to anyone who is interested in attending. Please feel free to drop in and out of the talks and exhibition area as you like.

The full programme is available to download and there will be exciting exhibitions from many stroke organisations throughout the day.

This year the meeting is being held on Friday 28th October, just one day before World Stroke Day, and is at the DW Stadium in Wigan.

As ever, it is free of charge but places are limited to 150 spaces and in previous years we’ve had a waiting list for people wishing to attend. If you’d like to come you must book your place with the NW SRN Administration Team Pamela Haslam and Catherine Keaveney by calling on: 0161 206 2018.

The deadline for registration is 23rd September 2011.

Written by Jo Nugent, Online Communications Officer, Greater Manchester CLRN

I started working for GM CLRN in March 2011 and as part of my training I’ve recently completed a Good Clinical Practice (GCP) training course.

The course was delivered by Julia O’Toole, Senior Manager,Greater Manchester Comprehensive Local Research Network (GM CLRN) and is aimed at GPs, practice nurses, healthcare assistants and admin personnel who will be working in the clinical research area.

The course outlined the principles and key components of GCP, as well as the regulations and the responsibilities of the different people and organisations involved in research.

As I’m new to research, I found the course was really good at giving me a background to the field as well as providing valuable information on:

• Why research is important and lessons learned from past experiences
• Responsibilities of the Sponsor, Investigator and Care Organisations
• Consent – who can take consent, what this means and how to obtain consent
• Trials – provides background information, description of objectives and details about the different phases of research.
• Phase 1 – The experimental drug or treatment is given to a small group of healthy volunteers (20-80) to evaluate its safety, determine a safe dosage range and identify side effects
• Phase 2 – a larger group of participants (100-300) trial the experimental drug or treatment to see if it is effective and to further evaluate its safety
• Phase 3 – large groups of participants (1,000-3,000) trial the experimental drug or treatment to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely
• Phase 4 – this phase involves post marketing studies to delineate additional information including the drug’s risks, benefits and optimal use
• Safety – talks about Adverse Events (AE), Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) and how they should be reported
• Documentation – outlines responsibilities of keeping the Trial Master File (TMF) up to date, importance of storage and archiving
• Audit – Accurate and complete records that are legible and data should be consistent with source documentation and made available for inspection
  

GM CLRN organises a number of GCP training events for all levels of people who are involved in research. If you would like to attend GCP training or for more information please email the GM CLRN Training team

Written by Craig Johnson, Information and Portfolio Manager, Greater Manchester CLRN

I work across all areas of the network to provide up-to-date and accurate data on all aspects of clinical trials.

I’ve been at the CLRN for nearly two years now and during this time there has been a significant increase in the amount of information I have to provide both nationally and locally. During this time we’ve seen recruitment double, which has brought a subsequent increase in requests for reporting and uploading.

One of the main parts of my role that most people see is to produce clear, simple tables and graphs that pull together all the data we receive from UK CRN.

I also produce GM CLRN’s regular monthly performance information for our Trusts and Local Specialty Groups (LSGs). They’re very popular with our researchers and RM&G staff and have helped to encourage ‘healthy competition’ between our Trusts and LSGs and I believe they have contributed to us consistently remain as one of the top recruiting CLRNs. We work very closely with them and their researchers to ensure the timely uploading of recruitment data to the NIHR CRN Portfolio, which is in their best interests as well as ours.

Also, they aren’t shy when it comes to telling me if they think there is a mistake or they have a query with the data. But this is a good thing as it helps us to have more accurate records as well as proving our information reports are being read!

In the last 12 months I’ve been working closely with my RM&G colleagues to record CSP information for our regular CSP metrics. Again, we have had queries and questions about the data but we’re being open and honest about our performance and I think that it has helped our Trusts and researchers to improve their CSP data. It’s also helped to improve the links between portfolio, CSP and recruitment information reporting.

As more importance has been put on commercial activity, I’ve been working closely with our local industry team to develop how we keep track of commercial activity and activity at local GP partner sites. I’ve also been working with Jonathan Aitchison, my counterpart at Cumbria and Lancashire CLRN, on a database to track studies recruiting to time and target.

All this reporting helps to show just how well we are doing as a CLRN locally as well as contribute to the work all the Networks do nationally. It not only shows our business performance but also reflects the hard work of all our research teams in Greater Manchester and our shared goal of improving public health.

If you have any Information or Portfolio queries please get in touch via email or call me on: 0161 291 5889

Written by Adrian Warner, TrusTECH Project Manager

We’re now over three months into the Greater Manchester pilot that is working to bring more medical devices and diagnostics (known more broadly as Medtech) research into Clinical Research Network activity.

So far we’ve been working with ten studies to help them be accepted onto the NIHR Portfolio and gain support from GM CLRN. Support for these studies has varied but we’re helping in a number of areas, including matching industry with potential clinical researchers, helping to design research protocols, assisting with costing the research and acting as the interface between Medtech companies and the NHS.

In order to benefit from Clinical Research Network support, the research project has to have a scientific protocol with endpoints that generate the clinical evidence of value to the NHS and for patients. Research projects, whether commercial or non-commercial must be fully funded. The highest priorities for provision of NIHR CRN support are those studies that are: funded by the NIHR, other areas of central government or an NIHR non-commercial partner; adopted commercial contract research (i.e. both funded and sponsored by industry).

Initially, our focus has been on the following GM CLRN priority group areas:

• Ear, Nose and Throat (ENT)
• Ophthalmology
• Endocrine/Diabetes
• Gastrointestinal (GI)
• Musculoskeletal

But we’re now open to all Medtech companies as well as researchers who have specific interests in devices. So if this applies to you or if you’re just interested in finding out more about the pilot and what we can offer, please contact me

The Greater Manchester Medtech pilot is being run by TrusTECH with support from GM CLRN and Adrian Warner is the Project Manager.

TrusTECH is the NHS innovation hub for the North West and is dedicated to improving healthcare through: maximising the potential of innovation for innovators; assisting Trusts to manage innovation; and helping industry access NHS innovation and expertise.

Written by Professor Chris Griffiths, Theme Lead for Skin and Wound Healing

There is a substantial and diverse collection of dermatology studies being conducted in the region. Current work ranges from efforts to increase our understanding of skin aging and inflammation, to commercial trials of state of the art treatments for psoriasis.

The number of trials adopted onto the NIHR Clinical Research Network portfolio is increasing, along with the number of patients taking part in dermatology research in the area. We now have approximately 20 NIHR adopted trials, of which six are commercially sponsored.

I am delighted to be leading the IMPACT programme of research, which aims to improve the care of people with psoriasis. IMPACT (Identification and Management of Psoriasis Associated CommorbidiTy) has been awarded a £2m NIHR grant and is only the second NIHR programme nationally to be awarded in the field of dermatology. Psoriasis can have a major impact upon patient’s quality of life, and it appears that many psoriasis patients may be at increased risk of developing other conditions, including depression and cardiovascular disease. I believe that this five year programme will allow us ascertain the true association between psoriasis and these conditions and will enable us to design community-based services that will be of direct benefit to this overlooked group of people. One of the key aspects of the programme is its multi-disciplinary nature, involving professionals with wide ranging expertise.

Considerable progress has been made over the last decade in our quest to find the cause of psoriasis. The consequence has been the development of more effective treatment options in the form of targeted ‘biologics’. NICE has recommended registration for all UK patients receiving these new therapies for psoriasis, and we are proud to be an active recruitment site for the British Association of Dermatologists Biologic Intervention Registry (BADBIR).

As an increasing number of clinical trials in dermatology are on mild to moderate severity disease we are starting to actively engage with primary care for recruitment. Additionally we have been asked to manage the dermatology portfolio in the Cumbria and Lancs CLRN.

I would like to take this opportunity to welcome any interests of collaboration, particularly from primary care. I believe that forging closer links with centres will improve the efficiency and effectiveness of dermatology research in the region. Please contact Susan Moschogianis, Research Assistant for more information.

Professor Chris Griffiths (pictured) has been GM CLRN’s Theme Lead for Skin and Wound Healing since 2008. He is Professor of Dermatology at The University of Manchester and Consultant Dermatologist at Salford Royal NHS Trust.

Written by Julia O'Toole, Senior Manager, Greater Manchester CLRN

To give some context to our funding news for 2011-12, Julia O’Toole, Senior Manager, (pictured) sets what the funding means for GM CLRN in the coming year.

First of all we’ll be building new capacity. The two new Local Specialty Group initiatives – Infectious Disease & Vaccine Research; and Accidents, Emergencies, Critical Care – which were successful in receiving additional national funding towards the end of 2010 will now be embedded into CLRN core funding and continue to be supported in 2011-12.

Secondly, as there has been no inflationary up-lift in funding for 2011-12, increases in operational costs and salaries will need to be met through efficiency savings. We will make every effort to work with our member NHS Trusts, Local Speciality Groups and Theme Leads so that all research infrastructure posts that contribute to recruitment into NIHR portfolio studies and the performance of their speciality groups will continue to be supported.

Thirdly, we have been tasked with reducing our overall RM&G funding to member NHS Trusts. Therefore we will need to work closely with our member NHS Trust R&D departments so we can identify any possible efficiency savings. Any savings that are made will be re-invested in our research infrastructure support. This important work is being led by Jane Pearson, Lead RM&G Manager.

And finally, thanks to the work done with our researchers and partner R&D departments for 2011-12 we have been able to predict an overall increase in recruitment of three percent. Of course this figure will vary Trust-by-Trust, depending on which specialties they represent and the studies being undertaken. We look forward to beating all our predictions again.

So whilst 2011-12 has seen a significant uplift in funding we will need to continue to work closely with all our partners to support new initiatives, maintain stability in the workforce, meet the required efficiency savings, beat our predicted recruitment figures and meet national objectives.

I would like to thank everyone across our CLRN and partner organisations for your hard work in the past year in making Greater Manchester such a successful region for clinical research.

If you have any more questions on funding, Julia can be contacted via email or on Tel: 0161 291 5910

Written by Tariq Aslam, Theme Lead for Ophthalmology

I’ve been in post about a year now and was appointed when the theme started in 2010. Before then only one patient was recruited to NIHR adopted ophthalmology trials in 2009/10. For 2010/11 we’ve already recruited 40 patients and we’re seeing the number of patients nearly double every six months as the number of studies we have increase.

On the commercial side of things we’re concentrating on trials that help people with the most common visual impairment. We’ve already seen treatments for wet macular degeneration and diabetic retinopathy really improve in the last few years with the introduction of anti-VEGF agents. We’re now looking at how we improve the delivery of these treatments and how we can better treat dry macular degeneration, which is a much more common problem but has fewer treatment options.

The Theme specialises in a number of different areas. Personally, my own research focuses on using existing technology to develop new and novel therapies. There’s been so many technological advances in imaging in the last few years but there’s currently very little interface with medicine. So I’m using at current technology, such as multi-spectral cameras and game technology, and seeing how they can be adapted using our own software to treat patients. By doing this, we’re aiming to diagnose and treat vision problems faster and more accurately.

Using this technology can also help with diagnosing problems in children. Because vision tests require the child to sit with their head still for quite a long time – and we all know that is very difficult for them to do – it can be very difficult, and at times impossible to get a proper reading. This technology gives them something interesting to concentrate on and enable us to get a proper reading.

We’re also investigating better ways to monitor patients’ vision. This could mean them testing themselves at home via a mobile device or at a GP surgery rather than coming into hospital. This would save time and money for both the patient and the NHS and be a far more accurate way of testing their vision. We’re looking at how we can join together the many aspects of testing vision to improve the service patients receive as well as the treatments we can offer.

We’re very keen to work with companies who are interested in developing new treatments or from patients who would like to take part in research so please get in touch.

Mr Tariq Aslam is GM CLRN’s Theme Lead for Ophthalmology. He is a Consultant Ophthalmologist at Manchester Royal Eye Hospital, which is part of Central Manchester University Hospitals NHS Foundation Trust. He is also an Honorary Senior Lecturer at the University of Manchester.

Written by Natalie Goulden, Programme Manager, Greater Manchester CLRN

Last week I attended the NHS Innovation Expo at ExCel, London which provided an opportunity to see how ideas in the NHS can be translated from a ‘light bulb’ moment, through research, into innovations that can be implemented and make a real difference for patients.

I was part of a team demonstrating innovation across NHS North West and the event provided a great opportunity to talk to colleagues from across the country.

Perhaps the major challenge for the next twelve months that came out of the Expo was to ensure that research and innovation stay at the forefront as GP consortia are formed and huge changes take place in the way that care is commissioned .

The Expo featured a wide range of speakers, seminars and exhibitors, all attempting to demonstrate how innovative ideas can improve patient care and increase efficiency in the NHS. Innovations ranged from simple streamlining of services to highly complex technology.

Speakers included: Andrew Lansley, the Secretary of State for Health; Sir David Nicholson, NHS Chief Executive; Lord Howe, Parliamentary Under Secretary of State at the Department of Health; and Ben Page, the Chief Executive of Ipsos MORI.

Andrew Lansley said that the NHS will encourage innovation in three ways: by placing the patient at the centre of decision making about their own care; through a focus on improving outcomes; and by placing power in the hands of local clinicians while getting rid of bureaucracy.

Ben Page of Ipsos MORI reminded the audience that we shouldn’t assume that we know what is important to patients. For example, the vast majority of people surveyed by them would always choose to be treated at their local hospital, rather than travelling to another site, in spite of the choice available to them.

There are real challenges in continuing to maintain high quality health care, innovating and improving that care; and doing all this at a time of rapid change, particularly in primary care.

We need to ensure we meet these challenges and ensure the ‘light blub’ moments continue to deliver real benefits for patients.

Written by Professor John McLaughlin, Theme Lead for Gastrointestinal

I've been theme lead for about 12 months and it's been great to see the increasing number of people who are interested in research across Greater Manchester and in the wider North West. We’ve seen improvements in both the number of sites and investigators who are taking part.

As a clinical discipline, Gastrointestinal (GI) works across a number of hospital areas and this is reflected in the research we do. This is often in collaboration with other disciplines. For instance, some of our studies are co-adopted onto the NIHR portfolio with the Cancer, Primary Care or Genetics themes. One of the main studies we’re recruiting to is looking at the genetics of inflammatory bowel disease. This study is being run by Dr Bill Newman, GM CLRN's Genetics Theme Lead, but involves a lot of GI work to identify and recruit particpants, so it's co-adopted. We’ve also recruited over 70 patients across seven sites to the BOSS study which is a long-term, NIHR-funded study looking at the value of endoscopic surveillance in Barrett’s oesophagus patients. This is a large part of the endoscopist’s workload, yet the evidence that Barrett’s surveillance is useful is surprisingly limited.

Historically, GI research in Greater Manchester has been carried out in the large teaching hospitals. However, I'm glad to report that we’ve seen an uptake in research at a District General Hospital (DGH) level. A real exemplar of this is Dr Yeng Ang who is a Consultant Gastroenterologist at Wigan Royal Albert Edward Infirmary. Dr Ang has a number of studies up-and-running and we're working with him on future plans and support from the CLRN.

I'm very pleased to say that we’ve seen a number of new GI consultant appointments in the region and these staff are keen to be carrying out research. Many of these consultants trained in the North West and have recently done research as part of their PhDs.

On the commercial side of things, there aren’t very many Pharma studies out there at the moment in Gastroenterology, and across the theme we’re taking part in nearly all those on offer. We are working with companies to look at studies around new treatments for inflammatory bowel disease and complications of diabetes affecting the gut, as well as looking at how anti-TNF drugs compare against other treatments. We’re also looking at how we overlap with the nutritional side of gastroenterology. For example, iron deficiency can be a major issue with some GI patients and we're interested in developing this side of our research.

Another area of interest is in diagnostics such as those used in GI Physiology departments and nuclear medicine. Gastroenterologists are usually busy endoscopists, so use of such devices may also prove fruitful avenues to explore. We also have several academic studies underway looking at physiological aspects of the gut-brain axis with Research Council funding.

In terms of NIHR and GI in Manchester we've been successful in what I think is the NIHR's only programme grant for GI in the UK. Led by Prof David Thompson and Prof Sarah O’Brien it's co-adopted with the Primary Care Research Network and is evaluating better patient orientated management of chronic gastroenterology disorders.

One of Manchester's very active research nurses - Karen Kemp - has also secured an NIHR PhD fellowship to look at qualitative research from the experiences of both patients and clinicians with inflammatory bowel disease. Another IBD Grant was secured by Dr Simon Campbell at Central Manchester with Karen from the National Association of Crohn’s and Colitis: both will be on our portfolio. And we also have a research fellow, Caroline Henson, who has recently been awarded a Macmillan grant to look at post-radiotherapy gastrointestinal dysfunction.

While we may be one of the smaller themes within in Greater Manchester, we're very much involved with collaboration to further increase research that has real benefits to patients so if you're interested in GI research then please get in touch.