What is clinical research?
Clinical research is the study of health and illness in individuals. By conducting this research, healthcare professionals and scientists can develop a deeper understanding of various diseases, specifically regarding the detection, diagnosis, treatment and prevention of disease. Clinical research may take the form of clinical trials e.g., drug or medical device trials or observational studies.
Benefits for patients
Ultimately, the goal of clinical research is to increase knowledge and provide evidence to inform clinical decisions, which is vital for ensuring the best possible care for patients. Following the COVID-19 pandemic, the benefits of clinical research have never been more apparent.
It is known that patients in research-active institutions have better outcomes than those who are not involved in research. For example, patients are more likely to benefit form earlier access to new treatments, technologies and approaches. It is therefore necessary that more research is translated from bench to bedside within the National Health Service (NHS) so that even more patients can benefit from improved outcomes. To facilitate this, improved physician engagement in research is necessary.
A unique role for doctors
Daily clinical contact makes doctors uniquely well placed to identify which research questions will make a difference to the lives of patients, and what kinds of new treatments or processes would readily be translated into clinical practice – meaning that if research is to have an impact, it is necessary to ensure that doctors have the time to contribute.
Participation in clinical research is in fact a key requirement for doctors in training to keep up to date with the advances in modern medicine and it forms one of the seven pillars of Clinical Governance defined by the General Medical Council (UK). Accordingly, participation in research is included as an assessment criterion as part of doctors’ ongoing professional development portfolio whilst working within the NHS.
Additional skills/benefits of undertaking clinical research include:
- Developing critical appraisal skills,
- Understanding research methodology,
- To be able to answer questions that arise in daily clinical practice,
- To develop/refine skills in manuscript writing and oral presentation and create potential opportunities to present at local and international conferences,
- To develop networking opportunities: Research is frequently collaborative and multidisciplinary therefore, being involved in research projects will help junior doctors get to know seniors in the field of career interest and related careers, which is beneficial for job applications. It is also great for creating partnerships and relationships with other researchers and clinicians within the hospital/network.
- Gaining a competitive edge: Undertaking research is highly valued when applying for more senior positions in certain specialties e.g., surgery and academic specialties where research publication and conference presentation is required to accrue extra marks or points towards your CV,
- Academic job opportunities.
Barriers to research participation for doctors in the NHS
Without clinician participation clinical trials would not be possible; however, doctors can face multiple barriers to participating in clinical research.
With highly demanding and frequently unpredictable working hours, it can take considerable planning and determination in order for junior doctors to become involved in research. As highlighted above, undertaking research projects and publications is considered even more critical with the acceleration of evidence-based medicine and the increased competition for jobs, especially with the rising number for medical school graduates.
1. Lack of time
Generally, there is high enthusiasm amongst doctors to participate in clinical research, although this is often offset by the overwhelming amount of work and responsibility of being a doctor in the NHS.
According to a survey by the Royal College of Physicians (RCP) in 2020, lack of time is the greatest barrier to research involvement for doctors. This is understandable since involvement in research is usually an additional (and unpaid) undertaking, often alongside a full-time clinical job with unpredictable hours. There is no protected time dedicated for research and ultimately, patient care/service provision is the priority, which can vary depending on the specialty/department to which a doctor is attached. Unfortunately, in many cases, doctors will have to sacrifice their personal time to be able to undertake research, which is not appropriate.
Additionally, doctors need to factor in mandatory study days, annual leave and rest-days following night shifts. Adequate rest is necessary to prevent clinician burnout – especially in the current climate of the NHS this is more difficult than ever (post-COVID-19 waiting lists and industrial action over pay). Furthermore, the increase in vacant job posts puts pressure on doctors to cover colleagues to ensure that patient care is not compromised, further reducing the opportunity to take part in research.
For those who are keen to undertake research and potentially pursue an academic career, there is a possibility to take time out of the training programme as an ‘out of programme (OOP) experience’, although this will increase the time taken to complete training and can have a financial impact on individuals (not doing out of hours work and taking longer to achieve a consultant salary).
2. Lack of knowledge/skills
Despite the requirement to undertake research as part of junior doctor training, many doctors may feel out of their depth and lack the necessary skills to do so, since they have not been exposed to research activity previously. This is especially true for doctors in the early stages of training who do not have expertise in a specific specialty. The RCP also found that despite men and women being equally drawn to research, women were less confident in their skillset.
It is often the case that doctors will need to ‘seek out’ their own research opportunities by liaising with senior colleagues, since there is no routine provision for this. A lack of senior doctors undertaking research also reduces the availability of supervision for junior doctors. It is also apparent that there is a perception that involvement in clinical research is only for the academically astute or those wishing to pursue an academic career, when in fact undertaking research can open many doors by providing doctors with many transferable skills for clinical and non-clinical workplace settings.
3. Institution and financial barriers
It is not surprising that larger city hospitals with ‘teaching/university hospital’ status will have better research opportunities than smaller hospitals in rural areas. They are often connected to reputable academic institutions that have ample resources to undertake research and can provide access to clinical trials and academic supervision. Furthermore, they have dedicated research funds, which smaller hospitals do not.
4. Bureaucracy
It has been observed that there is excessive bureaucracy within the NHS in terms of conducting clinical research and it has been criticised for the lack of transparency; a focus on compliance, rather than enabling research; and a focus on well-established or ‘big name’ researchers around the hospital, rather than proactive encouragement of research participation across the workforce. Access to Research & Design (R&D) departments should also be made easier for junior doctors.
Excessive bureaucracy in gaining ethical and regulatory approvals can also be responsible for the delay in initiating research studies.
5. Other
In addition to the points above, inequality of access to participation in research for women and ethnic minorities has been observed. It is important that the causes of these inequalities are investigated and addressed to improve representation. One reason for the under-representation of female clinicians in research may be that childcare commitments may not allow for additional work outside of the clinical job and for those taking maternity leave, taking time out of training for an OOP experience would further prolong their clinical training.
Breaking down the barriers
To help address the barriers to research participation by doctors in the NHS, a ‘National Strategy’ has been proposed by leading professional bodies including the GMC, NIHR, DHSC and the RCP.
The recommendations from a report by the RCP, titled ‘Research for all: Building a research-active medical workforce’ are as follows:
- Hospital Trusts should take steps to ensure that doctors have protected time for research and can make efficient use of that time.
- R&D departments need to ensure that they are active enablers of research as well as having oversight of clinical research.
- Trusts and universities need to adopt employment policies that facilitate employees to move between NHS and university employment without losing employment benefits that are contingent on the length of service. This is a particular issue in respect to parental and maternity leave.
- Research funders should consider collaborating to make the grant application process more straightforward. As many respondents noted the time and effort required to apply for funding felt excessive.
- Royal colleges and specialty societies should include sessions on research skills and engagement in regular conferences.
Additionally, the report believes that doctors should be more proactive in talking to their seniors/R&D departments about what research opportunities are available and should consider making contact with local research networks to be aware of trials in their specialty. While this is a good recommendation in principle, in practice the reality is that doctors are already too overstretched with their workload to make this a priority.
Medical Device Trials – A golden research opportunity?
Despite the efforts put in place to improve access to research opportunities, barriers to participation by junior doctors remain an issue, perhaps even worse in the current climate of doctor shortages and strikes. Improving access to research by conducting medical device trials may present a solution to overcome these.
Unmet need in the medical device industry
For a medical device to retain its CE mark (or other relevant regulatory approval e.g., UKCA), manufacturers must conduct a clinical investigation of their device as part of post-market surveillance to determine whether it remains safe and effective and conforms to relevant regulatory standards.
A major problem is that medical device manufacturers do not always have direct access to clinicians who use their devices, meaning that there is no pathway to establishing trials. This disconnect hampers the collection of vital safety and performance data and means that continuing availability of the device on the market is at risk. It’s vital that more is done to link device manufacturers with physicians who use their products.
Evidently, there is an unmet need in the medical device industry to link manufacturers with clinical sites to perform these studies according to their specific needs. Combined with the unmet need of the NHS providing research opportunities for doctors, what if medical device manufacturers could more easily conduct medical device trials at clinical sites within the NHS?
A further bonus is that most medical device PMCF studies on approved devices are classed in the UK as a ‘service evaluation’, meaning that they are exempt from the need for ethics approval. This really helps to reduce approval times and enables more studies to be conducted within a given time period.
Clinical Investigators for PMCF studies
Mantra Link, offered by Mantra Systems Ltd, is a unique initiative which aims to link medical device manufacturers with clinical investigators/sites, to facilitate the conduct of medical device trials within the NHS while providing mutual benefit to both parties. Alongside solving access problems for manufacturers, medical device PMCF studies apply to effectively all clinical specialties and all types of hospitals, opening up invaluable research opportunities for doctors (and allied healthcare professionals), particularly in smaller hospitals not linked to academic institutions.
The benefits of this setup could include:
- Easy access to a range of medical device manufacturers,
- Clinical prestige for the conduct of research,
- Financial remuneration for the conduct of research,
- Funding for the studies covered by the manufacturer,
- Opportunity to publish/present research outputs,
- Support in the conduct of the research,
- Autonomy for the clinical investigator/site in delivering the research,
- Reduced regulatory red tape.
If you agree that bringing device manufacturers and clinicians into closer contact will bring universal benefits, and would like to know more about Clinical Investigators for PMCF studies, please contact our team for a free and confidential discussion.