There may never have been a more difficult time to be on a trust board. The pressure on boards to balance finances, quality, operational delivery and long-term strategy can seem overwhelming. In this context, participation in clinical research by a trust might seem to be a lower priority, or even a non-essential luxury. However, what if, instead of being an additional challenge, clinical research actually proves to be part of the solution, and a useful mechanism for meeting many of the challenges which trusts face, without additional cost?
For over a decade now, NHS research and development has been the responsibility of the National Institute for Health Research (NIHR) and within this, the Clinical Research Network (CRN) supports research delivery. All NHS trusts participate to some degree in research, and the opportunity for patients to take part is recognised as a right in the NHS constitution. There are at least six good reasons why it is important to begin to consider clinical research on an equal footing to service delivery, and indeed why it should come to be thought of as an "integral part" of the provision of clinical care, wherever practicable. This makes it central to the mission of every trust.
Evidence shows that trusts which are more intensively involved in research have better clinical outcomes.
clinical director for NHS Engagement at the NIHR Clinical research network
Firstly, evidence shows that trusts which are more intensively involved in research have better clinical outcomes, even for patients not directly enrolled in research trials (appendix 1). Participant experience surveys run regularly by the NIHR CRN show that 90% of patients have a good or better experience of research. The majority take part through altruism. They want future patients to have improved treatments and for knowledge of their condition to advance. They also often receive access to novel treatments or better monitoring of their condition. Research-active organisations encourage their clinicians to be aware of current thinking and best practice for all the care they provide.
Secondly, future improvements in care will rely on evidence generated by current research. During 2020, the COVID pandemic demonstrated what can be achieved when research is prioritised. 'Urgent public health' studies were completed in record time, and swift progress was made in discovering effective treatments. In the RECOVERY trial, recruitment was disproportionately high in many smaller trusts, often supported by clinicians not previously involved in research. The fact that the CRN was already in place was fundamental to the swift response, enabling over 130,000 participants to be recruited in just eight weeks. Similar rapid progress is now being made for vaccine trials.
Staff participation in research can improve recruitment and retention of the workforce.
clinical director for NHS Engagement at the NIHR Clinical research network
Thirdly, staff participation in research can improve recruitment and retention of the workforce. There is a national shortage of nurses, doctors and other allied health professionals, and strong candidates for posts have choices about where they work. Opportunities to participate in research can add greatly to the attractiveness of a post. Every employer needs to appeal to as wide a range of candidates as possible.
Fourthly, regulators such as Care Quality Commission have begun to take an interest in this area, for good reason. They are persuaded by the case that research participation leads to better care, and they expect all the organisations that they inspect to be able to give a good account of their involvement. This currently forms part of the "well-led" inspection regime in trusts, and the basic principle that research participation is associated with better care and better patient outcomes is well established in this context.
Research can provide additional income and substantial savings on the costs of treatment.
clinical director for NHS Engagement at the NIHR Clinical research network
Fifthly, research can provide additional income and substantial savings on the costs of treatment. Research is funded by a variety of sources, including NIHR, other governmental bodies such as the Medical Research Council, the major charities (such as Wellcome Trust, Cancer Research) and a range of industries. Research which meets quality standards will be recognised by adoption to the NIHR portfolio, and organisations helping to deliver such research will receive support from their local CRN. A recent report produced by KPMG and commissioned by CRN (appendix 2) highlights the financial benefits that trusts can expect.
Finally, participation in clinical research can be beneficial to the reputation of a trust. Winning awards and receiving good publicity can boost morale across the workforce. Being known as an innovative and forward-looking organisation has positive benefits for all staff, and patients are attracted to organisations which can provide access to the most up-to-date treatments.
Some board members may read this and think: "Well that’s fine for large trusts and university hospitals, but it’s not really feasible for us." In fact, every trust in England (including community, mental health and ambulance trusts) is already participating to some degree in research, and has the potential to grow their involvement. The extent to which research activity is reported to boards in smaller trusts is variable, and there may be more happening than the board is aware of. It is important to ensure patient access to research treatment is available widely, and not just to the privileged population that can travel to a teaching hospital. Research conducted in the type of trusts that deliver most care is likely to deliver results which are more representative and applicable.
It is essential that all members of the board are aware of what is happening in the trust, and can assess the contribution of research to the overall performance of the organisation.
clinical director for NHS Engagement at the NIHR Clinical research network
So, what actions should be taken in the light of this understanding? Firstly, there should be regular reporting and oversight of clinical research activity at board level. It is essential that all members of the board are aware of what is happening in the trust, and can assess the contribution of research to the overall performance of the organisation. Secondly, all trusts should have a well-developed research strategy, and an identified board member to take responsibility for its delivery. Research needs to be seen as a whole board issue, and not just something for the medical director to worry about. An excellent source of help and support is the local CRN, and all trusts are strongly encouraged to develop close links with these. Finally, there are benefits to be had from engaging patients, the public and trust governors in the research agenda. Levels of interest in clinical research have never been higher in these groups than they are now, and it is the duty of all NHS leaders to provide opportunities for them to get involved. Recent events have demonstrated the value of clinical research in a crisis, and its importance in the delivery of routine care is becoming equally clear.
Appendix 1
- Levels of research funding and patient recruitment were associated with lower mortality among non-elective admissions in English trusts. (Ozdemir et al, 2015)
- There is a link between recruitment of patients to interventional studies and lower mortality among patients with colorectal cancer. The effects were found across all trusts (not just specific centres of excellence) after adjustment for casemix, and there was evidence of a dose-response relationship with increasing levels of participation leading to better survival (Downing et al, 2017).
- A correlation was found between clinical trial activity, mortality rates and Care Quality Commission ratings in English trusts. Patients admitted to more research-active hospitals had more confidence in staff and were better informed about their condition and medication. Associations were particularly marked for interventional research activity (Jonker and Fisher, 2018 and 2020).
References:
Downing A, Morris EJ, Corrigan N, Sebag-Montefiore D, Finan PJ, Thomas JD, Chapman M, Hamilton R, Campbell H, Cameron D, Kaplan R, Parmar M, Stephens R, Seymour M, Gregory W & Selby P. High hospital research participation and improved colorectal cancer survival outcomes: a population-based study. Gut 2017 66 (1), 89-96.
Jonker L & Fisher SJ. The correlation between National Health Service trusts' clinical trial activity and both mortality rates and care quality commission ratings: a retrospective cross-sectional study Public Health 2018, 157, 1-6.
Jonker L, Fisher SJ & Dagnan D. Patients admitted to more research-active hospitals have more confidence in staff and are better informed about their condition and medication: Results from a retrospective cross-sectional study. Journal of Evaluation in Clinical Practice 2020, 26(1) 203-208.
Ozdemir BA, Karthikesalingam A, Sinha S, Poloniecki JD, Hinchliffe RJ, Thompson MM, Gower JD, Boaz A, Holt PJ. PLoS One 2015 10(2), e0118253.
Appendix 2
Over a three-year period (financial years 2016/17 to 2018/19):
- For each patient recruited to a commercial trial supported by the NIHR CRN, on average NHS providers in England received an estimated £9,200 from life sciences companies, and on average saved an estimated £5,800 per patient (where trial drugs replaced the standard treatment).
- The estimated annual economic contribution of NIHR CRN supported studies increased by £0.1bn (gross value added) (up from £2.6bn in FY 2016/17, to £2.7 billion in fiscal year 2018/19) - linked to increased commercial contract research activity supported by the NIHR CRN.
- The number of studies and patients recruited onto NIHR CRN supported studies have both increased by approximately 30% in three years. (fiscal year 2016/17 – fiscal year 2018/19)
For the financial year 2018/19:
- Supported clinical research activity generated around £2.7bn of gross value added to the UK economy and an estimated 47,500 full-time equivalent jobs
- The total estimated income for the NHS from delivering commercial clinical trials was £355m, and the total estimated cost saving was £28.6m (where trial drugs were used in place of standard).
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