Research for pharmaceutical companies has long been a source of division in primary care. To some it is seen as fraternising with the enemy; using our patients as guinea pigs and largely driven by financial greed. Others see it as a welcome change from the usual clinical load, a useful partnership in the development of new therapies and also potentially profitable. Rarely are practices neutral about this subject. To date, more than 460 GP practices have taken part in commercial studies adopted by the Government-funded National Institute for Health Research (NIHR) and in particular its Primary Care Research Network (PCRN).1
In these difficult times of dwindling practice income, income from drug trial work is welcome. Although participating in drug trials is not for everybody, it is surprising how many patients, from all walks of life, agree to do it.
Here are seven important steps that will help you to set up a research trial and develop a fruitful relationship with the pharmaceutical industry.
Getting other partners on side
Some GPs feel uncomfortable working with the pharmaceutical industry, as it hasn’t always behaved in a totally honourable manner. Partners can also often have concerns about initial risks and outlay.
Although the viewpoints of these GPs might have solid foundations, many patients are surprisingly willing and enthusiastic about participating in research. To most, it doesn’t matter whether the project is academic or industry led.
The NIHR is keen to play its part in supporting the economically important life sciences industries, and takes the view that more patients should be offered the opportunity to take part in research through achieving a greater geographical spread of practices able to offer this.
All patients enter research voluntarily and there should be no duress whatsoever. It is clearly stated at the initial consent process that they can withdraw at any time without having to give a reason. All primary care trials require ethics committee approval before the sponsor can appoint investigators, and all trials adopted by the PCRN have been assessed by experienced researchers as well designed and beneficial to NHS patients, and approved.
It is a source of much frustration to practices who are interested in developing industry research that they can repeatedly submit recruitment feasibilities, but are never selected. There is an irony at work here – the industry wants more sites with experience, but practices cannot become experienced if they are never selected.
The PCRN is running several initiatives to open up access to clinical research to more patients in England.
At local levels, financial support for infrastructure development, training days on the basics of good clinical practice (GCP), mentoring schemes and hub-and-spoke models offer support and encouragement to practices keen to get started but not sure where to begin.
On a national level, there is much interaction between the PCRN and industry, with both parties recognising the common goal of improving recruitment and retention in research in the UK. Initiatives such as kitemarking to set a baseline minimal requirement standard at site level and developing the hub-and-spoke model of recruitment are being explored and developed.
Similarly, there are ongoing developments in the adoption, feasibility and application procedures, with the aims of improving transparency, simplicity and speed in these processes.
The PRCN is comprised of eight local research networks (LRN) that cover the whole of England. Typically, LRN teams include a network manager, research support staff from nursing and other health professions or life sciences backgrounds, data managers and administrative staff. A contact list for LRNs is available on the NIHR website (http://tinyurl.com/6wxpkpx), and you can also register your interest in running a research trial online by filling in a form (http://tinyurl.com/7z6ndlk).
For specific queries relating to industry research, Louise Forster is the PCRN industry liaison manager and can be contacted on email@example.com.
Through these networks, training will certainly be available and there is also the possibility of some financial support through the primary care incentive scheme (PCIS).
Some LRNs may be able to supply equipment and support staff, but most sponsors will provide the necessary equipment to undertake the trial work if it is not already available within the practice.
Finding the manpower
This is something of a chicken-and-egg situation. It takes a leap of faith for a practice to invest time and staff with a view to taking on research, unless it is guaranteed work and income. Yet a serious approach demands these investments as a minimum.
Start small, perhaps with just one doctor and a practice nurse interested in research. Reserve a portion of their week for research time and build this up gradually as work comes in. Consider gaining experience and confidence with non-commercial studies, which are less financially rewarding but often more straightforward.
Unfortunately, there are no guarantees about future work streams. In fact, if recent years are anything to go by, the opportunities for industry research in primary care have seemed to shrink rather than expand. The PCRN and industry are starting to work together, recognising the quality of research undertaken in the UK, and work that has diverted from the UK to cheaper alternatives may slowly return.
Dealing with a daunting training and contractual process
Most people working in research agree that the whole process has become bureaucratic and unwieldy. There is a protocol of more than 100 pages, along with a tranche of legal documents and financial disclosures, all requiring signatures confirming that you’ve read and digested every word. GCP training can also be off-putting, with
a heavy dependence on acronyms and quotations from European directives. The cost of GCP will vary depending on which members of staff are doing it, but all of it can be accessed through the local research network, most of which run at least annual training days.
The introduction of the Co-ordinated System for Obtaining NHS Permissions (CSP) is shortening the length of time it takes a clinical trial to start in the UK. Training is available through most LRNs and these courses tend to be sympathetic to those with little or no previous research experience.
Although it can be intimidating, GCP is necessary and offers the legal framework for what is, for the most part, common sense. If you practise in an ethical manner and follow protocols, you’re already a good way down the right track.
Getting extra support
In terms of support, for once we seem to be in something of a purple patch. There has probably never been more support and advice available for practices wanting to embark on research, either in industry or academia.
The NIHR and particularly the PCRN are now well established throughout a nationwide network. The Government has committed to support and fund more health research and indeed research seems to be one of the few areas in healthcare that is not being cut back.
Although reimbursements remain at a level that makes the extra work worthwhile, the overall trend is that trials have generally become a lot tougher to recruit for. It takes more and more time to search for suitable patients and go through the increasingly detailed trial procedures.
Having reliable, organised and experienced primary care nurses makes a tremendous difference in terms of day-to-day workload and it’s almost impossible to be a competitive trial site without these dedicated staff. Protected time for the investigator is vital and requires commitment from all practice staff.
Once established, it’s not difficult to achieve enough income to cover the basic extra staffing costs and there are still opportunities to make a worthwhile boost to practice income.
It might only take one trial with good recruitment to make a significant difference to practice income.
Income is variable. It is hard to estimate pay per patient. However, in my experience, an established and efficient research practice can earn in excess of £100,000 in a year through research work. But there is an element of luck required as you need to be selected as a site first, and then successfully recruit to time and target.
Be prepared to work
It would be wrong to pretend that all is rosy in clinical research in the UK, and to a large extent we are paying the price for past inefficiencies and mismanagement.
All pharmaceutical companies operate on a global scale and most will take their research where it can be done most cost effectively and efficiently.
Sadly, the UK has failed to compete at many levels and over the past 10 years we have seen a marked decline in pharmaceutical research activity, with some companies closing down their UK operations completely.
However, the industry recognises that for UK operations to survive there is a need to improve communications with trial sites.
In the same way that buying shares when the stock market is at a low ebb can produce better dividends later on, it could be argued that there has never been a better time to buy into industry research.
Dr Nick Jones is a GP in Midsomer Norton, Somerset, who has been actively involved in industry clinical research for more than 12 years. He is a member of BARONET (Bath Area Research Network) and industry clinical lead for the NIHR PCRN
1 Data from the National Institute of Health Research from 2008 to time of going to press