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The Stormy Seas and Distant Shores of Clinical Research Delivery

Posted 31.03.17 by in News

We welcome Linda Tinkler, academic research nurse, to the Making Research Better website with her article "The Stormy Seas and Distant Shores of Clinical Research Delivery". It's a personal take on the journey and challenges faced when conducting clinical research.

Raise the anchor, position the rudder, take a deep breath and prepare to set a course for the day. You’re heading away from the island of R&D in your tugboat, towards one of the islands just out at starboard….You’re visiting the towns of A&E, Out-patients, and Endoscopy today.

It’s the island of your organisation, the place where you deliver research day-in day-out. Above you a few helicopters are circling; each one has a purpose; Study Sponsor, LCRN, Industry CRO. Sometimes they land and inspect your little tugboat; they ask for a “sit-rep”, or sometimes they just hover above, monitoring from a distance until there is a need to land and gather more information or conduct checks.

Whilst heading towards the island, you navigate through the sea of emails, responding to requests for monitoring visits, site selection visits, amendments, an expression of interest, a response to why recruitment is lower than expected in a particular study, data queries (again!), an issue with a randomisation system, a meeting with a specialist nurse to explain a study and gain her support, the list is endless. The sea is high and stormy, you battle currents of acronyms, protocols, and endless site-files to keep in order…. Will you see a patient today?  You hope so; the patients are what make this job so rewarding; the opportunity to contribute to real developments in the prevention, diagnosis and treatment of illnesses, and to care for those patients prepared to be involved in this important work.

Drop the anchor at out-patients and step onto the shore, set about reviewing a clinic list for potentially eligible patients. You ask yourself “what were the inclusion and exclusion criteria again?” as you refer to copious notes made when you read the protocol. There’s one at 9am who may be eligible for a study, let’s try and speak to the consultant to make sure the research study is in mind when the patient is seen, is this a doctor who is interested in research? Will you be seen as a welcome visitor or a nuisance today? Nevertheless, smile sweetly, take a deep breath and start off with an apology “sorry to bother you doctor….”

Sounds like nothing more than Scuttlebutt?  Well, spare a thought for the humble Clinical Research Nurse. On the surface, it looks like a cushy job, and indeed it is hugely rewarding, exciting, and extremely satisfying, but it’s not all conferences and clipboards…….

Its 2009, I’m new into post as a CRN, elated and equally terrified! Having been in the NHS for some years, this is a real opportunity to work at the heart of shaping patient care, to make that difference so many of us choose a career in the NHS for …….isn’t it?

Approximately 6 weeks later, the first experience of recruiting a patient became a reality. Ethically challenging and emotionally testing, the encounter was one that’s familiar to most CRNs. Throw in some online GCP training; add meeting the team of a large, multisite HTA funded study about to commence (Who’s the HTA? I can remember asking myself at the time). Add in hours of protocol reading – essentially navigating through a complex instruction manual –  whilst trying to work out which bit was most concerning;  Was it the blinding procedures, the informed consent process, the intervention, the questionnaires? Who did what? How could we deliver this as a team? Then add in a target; a recruitment target. Targets are not unusual, but this was a new type of target, it brought funding for posts, it was the difference between study success and study failure, our team’s reputation as well as the organisation’s. Imagine this for numerous different studies, and those stormy seas can become difficult to navigate!

The reality of delivering research can be as daunting as it is exciting, but we don’t seem to talk about that. We talk about funding (because most contracts are temporary), we focus on high level objectives, time & target, accruals, RAG reports, attracting industry, and finishing on green. We don’t talk about the reality of delivering a range of complex studies, often for huge commercial organisations that depend on our data to drive forward their innovations – which will eventually lead to improved patient outcomes. We don’t talk about the elaborate mixture of selling yourself and your team (to get the study in the first place), the emotional labour involved in getting colleagues and indeed patients on board, the close scrutiny of accrual reporting, monitoring visits, and the ultimate pressure of delivering a study successfully.

We don’t talk about how it can sometimes feel to actually approach a patient to participate in a study. You see, there is something about the clinical roots you have as a nurse, that impacts on how you feel when you’re faced with asking a patient to participate in a research project. It’s essentially turning the caring nurse-patient relationship upside down. Are you offering them an opportunity? Are you selling a concept to them, or are you asking them a favour? How you feel depends largely on your belief in the study (as the patient’s advocate), and what it involves for the patients you are tasked with approaching, or so the literature seems to be slowly revealing – amongst other things.

So do spare a thought for the Clinical Research Nurse, working mostly on the outskirts – the shores – of the teams we encounter. We are, each day, essentially floating, in that stormy sea of research terminology, acronyms, study information and patients, between those islands of our organisation’s R&D department and the clinical teams we work with…… with the distant hum of those helicopters above. Wherever we may anchor for the day, we always return to our floating position, just on the outskirts…we never quite reach land, we never quite find a sense of where we belong – which island we should call home.

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