Ian Halstead talks to Pauline Boyle, acting chief operating officer of the National Institute for Health Research in the West Midlands, and hears the stories of two of its patients; Dr Andrew Thompson and Dietmar Bruck.
In this era of personalised medicine, where treatments are increasingly novel and specific, rather than traditional and generic, it’s vital that the NHS creates ever-more efficient pathways for patients to access innovative drugs as early as possible in their development.
The National Institute for Health Research (NIHR) operates through a 15-strong network of regional clinical research networks (CRN), giving patients the opportunity to take part in clinical studies; in the primary care system, at GP surgeries, dentists or pharmacies, or at hospitals and NHS Trusts. Such research offers individuals early access to new treatments, interventions and medicines, allowing the NIHR to assess which options can then be rolled out nationwide, ultimately delivering better and more cost-effective patient care through the NHS.
Pauline Boyle is acting chief operating officer of the Stafford-based West Midlands arm of the NIHR, and is rightly proud of the contribution which this region makes to the national network.
“Our primary aim is to increase the health and wealth of the nation through clinical research, and we offer patients the opportunity to participate in our trials, across a range of conditions,” she says. “For the 2016-2017 year, the West Midlands NIHR is the largest recruiter of people on to commercial clinical trials of all the regions, more than 3,000 patients, and we also have something like 850 ‘live’ research studies underway here.
“In March 2017, national NIHR data showed that one million patients had now taken part in research via their local CRNs, and it was very pleasing to see that at least 175,000 of those patients came from this region.
“More than 40% of our local GP practices take part in the primary care studies, and all our 28 NHS Trusts across the West Midlands participate in clinical research, which is of benefit to all patients in this region, regardless of whether they choose to join the research studies.
“It’s always been known anecdotally, that if you were treated somewhere which specialised in interventional studies that you had a much greater chance of survival than if you went somewhere else.
“However, there was also a recent two-year study of colorectal survival rates throughout England which generated ample evidence to show that patients did receive higher quality of care, at hospitals which carried out clinical research, and therefore had a greater chance of survival.”
Boyle also highlights a report commissioned by NIHR from KPMG’s economics team, published last November, demonstrating that clinical research created significant wealth and employment, in addition to delivering improved patient outcomes.
“Put simply, if a patient enters a clinical trial they benefit from access to novel treatments, and the NHS benefits because it isn’t paying for the drugs which are being trialled.
“All the CRNs look to engage with pharma companies of all sizes, but in the West Midlands we have a specific focus on SMEs, because there are so many of them in this region. We consider our SMEs to be a rich resource, and have established a dedicated industry team to which they can pitch ideas.
“At the moment, we are having a big push on what are known as ‘biosimilar’ drugs, which are drugs almost identical to an existing drug which has come to the end of its licence. Once copyright on the original drug expires, other manufacturers naturally try to produce something which has the same benefit for patients.
“We are very keen to promote clinical trials using biosimilar drugs, because the potential savings for the NHS will be enormous, as once the drug comes off licence, the price will tumble sharply, so we’re always looking to engage with innovative SMEs, who are capable of manufacturing such drugs.
“Patients receive the same quality of care as before, but the NHS can save its limited resources, and then switch those resources into other areas of healthcare. At first I was uncomfortable talking to patients about health, wealth and finance in the context of clinical research, but now it makes perfect sense.
“We’re also looking at how new research can guide us to the effectiveness of treatments. It might be, for example, that 10 sessions of chemotherapy using the latest equipment are as effective for patients as 20 sessions used to be.
“Obviously, the original figure was based on earlier clinical trials, but as technology improves, and as we understand more about particular conditions, then the numbers change. It’s always about delivering better outcomes for patients, but we also have to do more with less.”
“I’d never heard about clinical trials, but the advantages of taking part were pointed out to me by my doctor when I visited him for my constant coughing for over three weeks.
“My cough came on suddenly, I thought I was going to get a cold so wasn’t too concerned, although it did get progressively worse and then I happened to see a newspaper article advising anyone not to ignore a persistent cough that had lasted more than three weeks.
“As an ex-professional footballer for Coventry City, I am accustomed to having very regular medical attention and check-ups, so the thought of seeing my GP held no fears.
“I would advise people of all ages not to be afraid. Go and get checked out, because thinking it will be all right and will go away could be fatal.
“Sadly, three people very close to me thought their problem would go away, and I lost them all, including my wife, Maureen who was only 51. She was constantly tired and lacking energy, but thought it was because she was working hard, and that it would be OK soon.
“I insisted she seek help and took her to see her GP. She received excellent attention from the NHS, but blood tests and x-rays confirmed she had leukaemia, and she passed away three months later.
“From my experience, there were no downsides to participation in research. As anticipated, I was tested, x-rayed and generally well looked-after; I also had the advantage that I found out more about my body and learned more about my condition.
“Fortunately, my outcome was good. I would most certainly recommend it, and it made me feel good to know and understand.
“I would certainly be prepared to take part in another study: the more you know about yourself the better, and such knowledge could be very important.
“Participation in research is something I would wholeheartedly recommend. My own health is important to me, and I always try to make sure I keep myself fit by doing exercises, swimming, healthy eating and keeping my weight down.
“Now health research means so much to me, it shows how much the NHS is trying to help by making us aware of the importance of keeping healthy and fit - and by giving us good advice.”
Dr Andrew Thompson was a successful GP working with the homeless when a stroke changed his life, but taking part in clinical research gave him back his sense of purpose. After his stroke, which happened at home in May 2016, he got involved in several clinical trials almost immediately, having been approached whilst he was in Sandwell General Hospital.
He says: “It gave me something to focus on and was a positive in a negative situation. As a GP, and as an Honorary Senior Lecturer at the University of Wolverhampton, I had been involved in carrying out research in the past, so I was aware of the benefits it can bring to patients and the wider NHS.
“The experience has been positive and I have always got in mind that in being treated for my stroke, I am the recipient of the accumulated knowledge of colleagues.
“It’s the same response as when you are asked if you will be examined by a medical student - why not? If people don’t sign up to participate, then medicine wouldn’t be able to move forward.”
The studies he took part in included a drug trial, a speech and language trial and a cognitive capacity trial. He joined the first just a month after his stroke, whilst on the rehabilitation ward.
“I had no previous history of stroke, but was working a 90-hour week with substance misusers, as well as carrying out my duties as Assistant Coroner for the Black Country, and I am sure that fatigue and stress contributed to my condition,” says Thompson. “Taking part in research gives positive meaning to the experience of illness and I am now living independently again and am getting more involved in community life. I have always been active in the trade union movement and am still able to play my part.
“I would encourage others to ask about taking part in relevant research - it was part of my treatment anyway and some parts are really fun and interesting, which stops you from dwelling on your condition.
“The researchers were exceptionally helpful and flexible and if you are fortunate, the study can make a big difference to your recovery.
“Sometimes it can be hard to stay positive after such a life-changing event, but knowing you are helping to improve treatments for future patients gives you a whole new perspective.”