Abstract
Having had clinical research experience, not specifically in a nursing role, but as a clinical trials’ co-ordinator, I found this paper very interesting to read and could relate to many of the points put across. Although not directly involved in the recruitment of patients, I was always made aware of any potential problems at site with regards to recruitment and the eligibility of patients and would communicate these with the sponsor if necessary. For example, if Principal Investigators had questions about specific eligibility criteria for individual patients it would be my responsibility to follow up on this and carefully check the protocol.
Although recruitment to the ‘PREDICT’ study discussed in this paper ceased 7 years ago, and lessons have been learnt since, I found myself being able to draw on my experience in clinical trials and noticed some similarities with regards to recruitment challenges and miscommunication even now, 7 years later. This paper will certainly contribute to the evidence base and potentially enable large multi-site trials like PREDICT avoid running into similar problems in the future.
During my time in trials, I too witnessed an enormous waste of administrative resources as well as the time and expertise of the clinical research team. For example, a Phase 3 haematology study went through all the necessary approvals and opened at site, only to close 2 months later because global recruitment targets had been met earlier than anticipated. This was a miscommunication on the part of the sponsor and therefore completely out-with the hands of the research team at site, but I think this is a prime example of how miscommunication, whether that be from a sponsor or the site team, can result in time essentially wasted and much frustration when so much work has gone into allowing the study to eventually open. Approvals can take a long time and sites must determine whether they have the capacity, in terms of staff, equipment and space, to run a trial. Ensuring collaborative working at all stages in the research process is therefore paramount.
The paper suggests that too much pressure was perhaps placed on the research nurses for the PREDICT study to meet recruitment targets. Many were on short-term contracts, moving between sites regularly and quite often these nurses worked autonomously. Adding to this there did not appear to be enough nurses working on the trial at any one time, but this is a system issue and the responsibility of management to address. I agree wholeheartedly with the point made about providing more CPD opportunities to clinical research nurses, with more engagement and educational sessions, particularly in large studies like PREDICT where several sites are involved. To be able to share views and experiences regarding recruitment challenges, whether face-to-face or remotely, on a regular basis, is so important both for the smooth running of the study but most importantly for our patients who are perhaps reliant on a clinical trial and deserve a positive, smooth experience. It needs to be ensured that nurses feel supported and learning from others cannot be under-estimated.
Before starting in clinical research, I had no real prior knowledge of clinical research processes and I must admit, I was quite taken-aback when I realised the sheer amount of organisation required not just from the regulatory approvals point of view but the intricacy required by research nurses, and trial coordinators, to meet sponsor’s requirements. I soon realised how different every trial under my management was and the logistics and essential organisational skills needed to run all the trials successfully, for the benefit of patient care. More joined-up working between sites and well-resourced teams with achievable recruitment goals must be ensured prior to commencing a large-scale trial and nurses must feel supported.
My first introduction to research in nursing, like most nurses, was at undergraduate level. However, in hindsight, learning about the theory of research and writing an essay was not enough. A clinical research placement would arguably enable students to better appreciate the importance and relevance of what they are being taught and give students more insight into the possibilities nursing and research can offer (Council of Deans of Health, 2021). Clinical Research was a whole new world to me and one that I am extremely glad I had experience of.