Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials

Record-Breaking Trial Recruitment Now a Reality

A unique, wholly government-funded initiative has made the UK the hot ticket in clinical trial recruitment.



The tedious and slow process of clinical trial recruitment can be the bane of any pharmaceutical company engaged in clinical development. What if there were a service that had the required databases and registries, as well as accurate patient population data and a proven performance in record-breaking clinical trial recruitment?

Now, imagine this service already exists and is available to pharmaceutical companies free of charge. But you don’t have to imagine it, because it’s happening right now, with seriously impressive results.

Matt Cooper is Business Development & Marketing Director at the National Institute of Health Research Clinical Research Network (CRN) – the research arm of the UK’s National Health Service (NHS). Wholly funded by the Department of Health in the UK, this unique initiative aims to aid researchers to set up trials quickly and easily, by working closely with pharma, healthcare professionals, and of course, patients.

 

Accurate predictions

Cooper spoke to eyeforpharma ahead of his presentation at Clinical Excellence Europe 2016 about feasibility offers via the CRN, which have allowed the Network to more accurately predict recruitment targets with the result of significant increases in the timely delivery of commercial clinical trials to their agreed target.

The Network appears to function as a conduit between patients and industry, yet its lack of private interests is unique.

“The difference with CRN is that it is wholly funded by the UK government to build and run a national research infrastructure. We don’t design or conduct trials as such; rather our research nurses, data managers and administrators are all based in NHS organizations across the country and the researchers use our staff to help them run successful trials,” explains Cooper.

These staff work across all areas of the health service, primary, secondary and tertiary care; essentially, this network functions as a “backbone” for the operation of clinical trials by industry.

He explains that the CRN is focused on enabling patients to understand more about the trials process; for example, the CRN incorporates a country-wide portal listing all ongoing trials, resulting in a greater level of transparency to where those trials are taking place.

In addition, the UK Clinical Trials Gateway is another avenue that will soon be available – patients can search for trials and look at what is open in their locality via the geographical search function.

Unprecedented

While these efforts undoubtedly aid in clinical trial recruitment, the pragmatic approach taken by the CRN to trial feasibility is what has led to unprecedented results.

“With regard to the network infrastructure itself, what we have done to really increase the delivery of clinical trials quite dramatically is doing much better feasibility up front at a local level. We look at a trial protocol and we go and ask different clinical experts to really concentrate on the actual data rather than what they perceive to be the data,” Cooper outlines.

He says this concentration on feasibility has led to much greater levels of trials achieving their opening time and delivering trials to the target that has been agreed.

“It’s a fact that, if we are talking about commercial trials, these are carried out on a global basis as there is no one country that can deliver all the patients needed for any particular trial. The companies, by default, have to rely on information they obtain from each of the local areas where they are setting up their trials; it cannot be successfully run from just the global office based out of New York or Boston because they won’t understand the local issues around patient flows and the current standards of treatment in those countries and that’s where the CRN and our locally-based teams come into play.”

The CRN offers three different levels of feasibility studies to companies seeking to engage in research in the UK. According to Cooper, engagement as early as possible is preferable, even if the idea is just forming or the company has only a rough outline or synopsis of the study.  At a very early stage, a top level feasibility study can be carried out, meaning the CRN look at whether the study is going to be feasible, with regard to parameters such as the standards of care being used, the types of patients the company is looking for, or the various settings in which they want to see those patients.

The CRN’s national clinical experts convene to provide that feedback to the company in question, often within a very quick turnaround time and before they have begun looking at potential sites.

When the decision has already been made that a company wishes to bring a trial into the UK, two further levels of site feasibility can be offered. Often companies will come ready-armed with a number of pre-identified sites that they wish to work with, and the CRN will use its locally-based network of staff to check if those sites are appropriate. These may not be suitable for any number of reasons, which the company may not have previously been aware of.

“Often there will be key opinion leaders involved, so you sometimes have to make sure that the target for each of those sites are realistic and not necessarily the same targets as for all the other sites. Also,these key opinion leaders could be involved in other trials within the same setting so we need to ensure the patient population is sufficient for all trials at the site,” according to Cooper.

 

Quick and efficient

For companies that don’t have any idea of which sites they would like to use and are unfamiliar with the jurisdiction, the CRN then works to identify several potential sites across the country, also determining the potential patient population in these areas and what the recruitment levels could be. Companies can then select from this pre-identified list of sites.

“The feasibility process makes it easier to get things set up in a quick and efficient manner – to the companies the important thing is to get these up and running in a timely manner.”

This removes much of the legwork for pharmaceutical companies and, importantly, is a free service; Cooper explains that companies would previously have utilized third parties to carry out similar work, often at a hefty cost.

Another major advantage is access to data collected over the years by the NHS; a wide variety of long-running databases and registries. This type of information is particularly useful and highly coveted by companies when it comes to trials involving long-term chronic conditions.

We are really trying to challenge ourselves to be a world-leading destination for clinical trials; last year we recruited just under 35,000 patients into commercial clinical trials, which is a huge number of patients and a 35% increase on the previous year. That’s against the background of the academic clinical trials setting – we recruited over 600,000 participants in academic trials.

“Where it becomes slightly more challenging is in the disease settings where you are waiting for someone to present with something that isn’t a long-term condition. But in that case, it comes down to our track record and the background data; we have all the back catalogue of past sites and studies and how they worked in terms of what their target was and what they achieved. We can give a level of certainty to companies when they are placing trials here by providing the track record for centers that are being put forward.”

Trial destination

Unsurprisingly, this Study Support Service functions to attract clinical trials to the UK, and the number of patients involved in trials is growing exponentially.

“We are really trying to challenge ourselves to be a world-leading destination for clinical trials; last year we recruited just under 35,000 patients into commercial clinical trials, which is a huge number of patients and a 35% increase on the previous year. That’s against the background of the academic clinical trials setting – we recruited over 600,000 participants in academic trials. There is a vast amount of work going on here,” according to Cooper.

In terms of patient engagement, the CRN is split into 15 different localities, and it has patient/public involvement representatives in each who work to engage patients on an ongoing basis.

The CRN also run patient-facing campaigns, such as the “Ok to Ask” campaign, which proved to be very successful and garnered significant media attention in the UK.

“This served to empower patients so that when they entered an NHS organisation to have their routine treatment, they understood that they were perfectly entitled to ask whether this is a research-active organization and are there clinical trials which they could be suitable for,” explains Cooper.

Interestingly, the Network also ran a “mystery-shopper” style campaign, where patients were sent into organizations to ask frontline staff if it is a research-active organization and quiz them on the types of research ongoing in the center. The results were not positive, highlighting a high level of ignorance among staff about clinical trials.

“This illustrated that many frontline staff weren’t aware of research that was going on in their organizations and that led to a new wave of awareness campaigns, with the NHS saying that if you are going to be a research-active organization, then all your staff have to know about it and when patients come in, direct them to the best person to discuss their needs,” Cooper admits. As a result of the findings, the CRN produced a tool kit to help the NHS promote research to their staff and local community.

An unusual position

One particularly successful trial the CRN was involved in concerns the field of hepatitis C – one that has exploded in terms of new and better treatments in recent years. The CRN partook in the major international trial BOSON, run by Gilead to investigate Sovaldi, now on the market.

“We were recruiting so quickly within the UK, they asked us to stop recruitment in order to allow other countries to catch up, which is a very unusual position to be in.”

The trial took place in five different countries, and with the help of the CRN, the UK played host to 25 sites out of the total of 80. Cooper says the CRN recruited 248 of the 592 patients into that trial, with four of the top 10 recruiting centers from the UK sites.

“We were recruiting so quickly within the UK, they asked us to stop recruitment in order to allow other countries to catch up, which is a very unusual position to be in.”

Indeed, one trial site contract was completed and signed off within 25 days, which represented a new company record for Gilead. It’s unsurprising that this service is so coveted but what is surprising is that companies still rely on external parties to provide this level of expediency and efficiency.

Cooper believes that in many cases companies are victims of “more haste, less speed”.

“Companies are usually trying to get things up and running across many countries from their global office and are under pressure from their management to get things done quickly; I don’t think they always take the time to see what’s on offer and how the different countries can help them. We go out and talk to companies about what we can offer and what the CRN involves; we need to raise that awareness and keep reinforcing that message as staff within a company can change too.”

This raises the question – does such an organized approach to clinical trial recruitment require a fundamental culture change, instigated from the top down?

In fact, the CRN has changed its own approach, ensuring good relations with the UK affiliates but also engaging directly with the global teams at head office, which is often US based.

“We have a fantastic relationship with Pfizer for example; their Chief Medical Officer Freda Lewis-Hall came to the UK to meet with us about what the UK can offer, and how we can engage more and how the company can make best use of the resources within this jurisdiction. That message is now getting through and we are seeing the number of trials coming into this country increasing year on year and so is the number of patients recruited to clinical trials.”

Yet what has been crucial for this is the government support; something that other countries are envious of and undoubtedly gives the UK the edge when it comes to clinical trial site selection, Cooper admits, adding that this generosity is rewarded both from a health outcomes perspective, as well as budgetary implications.This is pertinent particularly in therapy areas like oncology, where an expensive therapy may be provided free by company, thereby saving potentially millions of pounds for the health service.

“It’s that support for the CRN that is funded by the Department of Health England which allows us to have that framework that companies can come into. That’s what other countries don’t have. For us, it’s a win-win. It is not just the trials that this brings into the UK, it is the patient opportunities as well as the cost savings to the local health economies by participating in these clinical trials, which can be quite substantial.”


Read more about the work the CRN do in our latest clinical whitepaper, "Advancing Patient Recruitment & Engagement in Clinical Trials".


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Patient-led Clinical Trials

May 8, 2017 - May 9, 2017, London

Where patients and pharma join forces to deliver empowered trials

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