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Spotlight on Commercial Research

The Myths of Commercial Research

By Sinead Collinge, Industry Operations Manager, Clinical Research Network West Midlands

sinead.collinge@nihr.ac.uk

In this article, I am going to address some of the most commonly asked questions about commercial research in the NHS.

 

What is ‘Commercial Research’?

This is the term used to describe medical research sponsored and funded by for-profit organisations such as pharmaceutical, medical device and technology companies. These organisations are private companies that can design, collaborate and fund research to be delivered in the NHS.

 

If it’s ‘for profit’, aren’t patients just guinea pigs being used to make companies more money?

No, in the NHS this really isn’t the case. Any NHS patient who gets involved in medical research, is a volunteer - they are never entered into any NHS research - commercial or non-commercial, without knowing and providing informed consent, so the term ’guinea pig’ isn’t helpful. The aim of the research, what the research will involve and any associated risks and benefits are fully discussed with the patient, prior to their involvement and they are able to withdraw from the research at any point, without their care being affected. Most clinical trials undertaken within the NHS are Phase II or later phase, where the aim is to see if the desired outcome is obtained over larger numbers of people. Some UK hospitals do have the capabilities to deliver early Phase I research. Patients are informed of all risks, their medical history is fully considered, and they are extremely closely monitored throughout the study. All research delivered in the NHS is reviewed by an independent national Ethics committee and ensures the research is of sound value and will not endanger patients. Each study is also reviewed by each hospital to ensure it can be safely delivered and patients cared for. Patients are not paid to be involved in NHS research, even if it is commercial, so there is no expectation from that side of things.

 

But don’t the companies make money from it?

The fact of the matter is that commercial companies do make money from selling new drugs and devices; however they are only able to sell them if there is a need. The NHS will not buy new products that it doesn’t need - they have to be approved by the

 

National Institute for Health & Care Excellence and be able to prove they can improve patient care and outcomes. A commercial company will be doing research to prove there is a need for their product, and that the product is effective. Importantly, commercial companies will also do studies that can prove their medications or products are not effective and therefore will no longer pursue their development. This information is published and this will also prevent anyone duplicating that research. The commercial company will pay the NHS to deliver research, the funds will cover the activities performed by the NHS for the research and provide some capacity building so the Trust Research department can grow and further its own research capacity.

Are the doctors paid to do the research?

There is no personal payment to the doctors who deliver the research - so there is no conflict of interest. Doctors will only take on research that they truly believe will benefit current and/or future patients. There are also collaboration opportunities between commercial sponsors and doctors - where the doctors on the front line who know the clinical issues, can work with commercial sponsors to try and solve these issues.

 

Myths such as these can compromise the progress of medical research which is essential to advance the medical care we receive as NHS patients. Commercial research can provide patients the opportunity to access new treatments, and also provide a source of income for a Trust to be able to develop and expand its own research. Without the support and input from commercial sponsors we would not be able conduct the research we do and advance and improve patient care.

 

 

Commercial Research in Primary Care

By Raj Gill, Industry Manager (Primary Care)

Clinical Research Network West Midlands

rajvinder.gill@nihr.ac.uk

 

This time last year the Primary Care Specialty nationally reached a fantastic milestone of recruiting the 1 millionth patient to clinical research. This milestone demonstrates how committed we are to giving our patients access to research and new treatments and innovations in healthcare.

Our vision for the future is to support general practices to continue their engagement in research amidst all of the changes in the NHS landscape. One way to continue this is to explore working with commercial research partners in order to give patients access to a wider range of research, access to cutting edge treatments, investment into practices wanting to expand their research capacity and drive economic growth for the UK. Supporting the life sciences industry is one of the NIHR’s high-level objectives and there is certainly an untapped potential within primary care.

 

How does Commercial Research work in NIHR Clinical Research Network (CRN)?

● All commercial studies promoted through the NIHR CRN are NIHR portfolio adopted, ethically approved, and undergo Health Research Authority approval as with any other study you may take part in.

● Commercial studies in primary care can be observational or interventional. Interventional studies compare a new or different type of treatment with the best treatment currently available. Observational studies simply observe and collect data on participants within a particular condition to learn more about how their condition. Data is usually collected via questionnaires or interviews.

● The studies within primary care are generally later stage phase III or IV trials testing new treatments for marketing authorisation purposes or to learn more about the long term effects of currently marketed medical products.

● All research activity undertaken by the practice is reimbursed by the commercial company via an approved NIHR Industry Costing template. this includes salaried costs, additional overhead costs and 20% capacity building element which

can be reinvested back into the practice to generate further research capacity.

● Our CRN GP steering group review all commercial studies to ensure they are suitable to run in primary care.

 

Why Primary Care?

Commercial Research has been conducted in the CRN West Midlands for a number of years with 86% of our trusts and a few practices engaging in commercial studies. Primary care accounts for over 90% of patients’ first interaction with the NHS and holds a rich source of data in the form of medical records for registered patients. Also, with the changing NHS landscape, primary care is delivering more services than ever meaning that commercial companies can look to this setting to identify patients for their studies, especially those with long-term chronic conditions. The new models of care emerging provide even more opportunities to deliver commercial studies within the primary care context taking advantage of the larger patient population and specialisms within the clinical teams. With income for general practice declining each year and costs of running a practice on the rise, commercial research can be one way of securing an alternative income stream.

 

Current Commercial Research activity in the West Midlands

In 2017, the CRN appointed an Industry Manager for Primary Care to increase commercial research activity across the West Midlands. There has been a significant increase in the number of expressions of interest submitted by practices across the region, especially due to a lot of ‘new’ practices undergoing training provided by CRN. We are currently seeing a number of our ‘new’ commercial research practices being selected for commercial studies in areas such as Dermatology, Diabetes and Osteoporosis. A number of our practices have also excelled in recruiting to studies on time and to target which not only enables implementation of the scientific findings into clinical care quicker but also ensures that the reputation of the practice is upheld which will ensure repeat business with commercial companies in the future.

 

Did you know . . . . The DECIDE study is a commercially sponsored study so your practice may already be involved in commercial research!

 

What does Commercial Research entail for the practice?

Practices wanting to deliver commercial research will act as research sites meaning that they take on the delivery of the study using their own practice staff.

 

Working in this way does require a cultural shift in the practice’s approach to research. It is advised that practices wanting to deliver commercial research develop a ‘research team’ at the practice including representation from each staff group i.e. GP, practice nurse, administrator and practice manager. Forming this ‘research team’ facilitates better communication, enables quick assessment of studies to determine interest and ensures efficient set up and delivery of commercial studies. Utilising practice nurses / HCA’s / medical associates enables the wider practice to develop professionally through research as well as reducing burden on the GP’s.


“With the support of the Network’s Industry Manager we were able to secure a commercial study and were assisted with set up at the practice which enabled us to deliver the study efficiently and successfully recruit to the study on time and to target. We shared the delivery of the study with a core research team at the practice including our practice manager to facilitate contract and costings negotiation, two GP’s receiving informed consent, our practice nurse to deliver the intervention and a member of our admin team to support the data entry requirements. This enabled us to deliver commercial research in the context of a busy general practice.”

Feedback on commercial research by a GP in Dudley


How does a practice get involved in commercial research study?

Applying to take part in a commercial study requires practices to follow a nationally defined process and is different in the way in which practices may apply to take part in academic studies.

As commercial studies are promoted to the CRN at a national level and studies may be in the funding/application stage, the companies want to be able to assess quickly how many sites they can find in the UK to deliver their study with the required number of patients needed per site. To express interest in these studies requires practices to complete ‘Site Identification’ forms which demonstrate to the study teams how they can reach the criteria specified. These forms are then sent to the commercial company to assess which sites they want to progress with. Competition is high for commercial studies as they are

often looking for a small number of sites across the UK and companies can receive a huge number of applications from interested sites. The key to securing a commercial study is providing an accurate and high quality Site Identification form, demonstrating previous clinical research experience and being available to liaise with the commercial company when they make contact.

 

How can the Network support you?

The Industry Manager is available to support practices with engaging in commercial research. This includes:

- Providing training on how to complete high quality expressions of interest.

- Support the practice to set up commercial studies at the practice including target setting, contract reviews, and cost negotiations.

- Attendance at all study set up visits

- Oversee and review patient recruitment

- Escalate any issues with delivering the study at local or national level for support and to share best practice

- Capture lessons learnt at study closure


“We had applied for a number of industry studies but recently had received no interest. It was frustrating and time consuming filling in the lengthy forms with no results. We were shown how to complete more effectively adding considerably more information and 'selling ourselves’.

I am delighted to say we have received a call this week checking out our continued interest and an agreement is to be sent out. Thank you…"

Feedback on the Commercial Research Training by a GP in Worcester


Not ready to deliver commercial studies yet?

Have you considered acting as Participant Identification Centre (PIC)?

Practices can refer potentially suitable patients to commercial trials taking place in local practices or hospitals through the use of postal invites, posters or opportunistically in consultation. This enables your patients to still access commercial studies taking place locally but also allows practices to experience commercial research with less commitment. If you would be interested in this please let your local Research Facilitator know.


Interested to hear more about Commercial Research?

If you would be interested in engaging with commercial research and to learn more about how to make it work within your practice, please contact:


Raj Gill | Industry Manager (Primary Care) rajvinder.gill@nihr.ac.uk | t: 01902 447196

Thu 22 Mar 2018, 09:49