Blog – Critical Roles That Fuel Clinical Trials

In the world of clinical research, the spotlight often shines on principal investigators, drug companies, and the outcomes of ground-breaking studies. I’ll give you an example… you’ve probably heard of Lecanemab right? But could you tell me where the drug trial for that study happened? Who administered the drugs? Who did the MRI scans? Who recruited the people who tested the drug?

Sadly we seldom celebrate the diligent healthcare professionals who work behind the scenes to turn theoretical research, and experimental drugs into actual clinical practice, and new treatments. These are the people in research delivery roles—Clinical Trial Practitioners (CTPs), Research Nurses, Allied Health Professionals (AHPs), and the multitude of coordinators and managers—each making unique contributions to the advancement of medical science.

I suppose it is about time I should disclose why I am actually writing this blog. Well, the truth is… that in the 13+ years I have worked at UCL and within the NIHR, the challenge of not having enough people to support delivery of clinical trials has come up, time and time and time and time again. Although, we also have the same challenge when it comes to people applying to clinical academic positions (both in the UK and elsewhere in the world). I won’t name names, but there are definitely a number of funding lines that are going unspent due to a lack of quality clinical academic applications (which is probably one of the reasons behind the new NIHR Pre-Application Support Fund).

Back to the point, because this blog is about delivering research, and not academia.

Research Nurses and AHPs: The Backbone of Clinical Trials

When it comes to the human aspect of clinical trials, Research Nurses and AHPs often take centre stage. Not only are they responsible for recruiting patients and obtaining informed consent, but their roles extend to taking blood samples, administering study drugs, and conducting necessary tests, or delivering the intervention. Their skills in patient advocacy ensure that trial participants are treated with dignity and compassion throughout the entire research process.

Clinical Trial and Research Practitioners: The Versatile Facilitators

Clinical Research Practitioners (CRPs) and CTPs offer yet another layer of expertise to research delivery. Their responsibilities are as varied as taking consent, screening participants, supporting data submissions, and engaging in protocol activities. With the right training, they can even participate in more complex procedures and sample processing. Recognised by the UK Professional Standards Authority, CRPs are indeed a significant pillar supporting the clinical trials scaffold.

Coordinators and Managers: Orchestrating the Research Symphony

Research coordinators and study managers have pivotal roles in ensuring the seamless execution of research plans. Whether they hail from clinical or non-clinical backgrounds, their contributions are indispensable. Their duties range from facilitating local submissions for NHS approvals to ensuring that studies have adequate resources. Their capability to liaise with services and sponsors while monitoring milestones makes them an integral part of the research delivery workflow.

Data Managers: Guardians of Integrity

Data managers are the custodians of the clinical trial’s integrity. They meticulously enter data, resolve queries, and perform quality checks to ensure that the data reported align with the protocols.

PI’s and Leadership in Research Delivery

These are usually the seasoned professionals who take up leadership positions in research delivery. Their roles can be extraordinarily diverse, ranging from managing specialist teams to coordinating efforts across multiple divisions and Trusts. These individuals often possess a rich blend of experience in conducting and coordinating research, making them invaluable assets to any institution. In the UK dementia drug trials have a Psychiatrist or Neurologist as leads, and often… a Trust will literally only have one person who does this. In fact, I would be willing to make a bet that there are probably less than 40 people acting as drug trial PI’s in the UK right now. Does that surprise you?

The recent progress made in finding new drugs to treat Alzheimer’s disease, is likely lead to a massive investment in more trials. New drugs, new companies, new approaches. On the conference circuit there is lots of chat about preparedness to deliver new treatments, but far less about preparedness to deliver more trials.

The labyrinthine structure of clinical trials and research projects is held together by the cohesive efforts of various professionals in research delivery roles – and we just don’t have enough people. Without them, the leap from laboratory discoveries to patient benefit is going to be virtually impossible (in the UK anyway…).

So here’s to the unsung heroes in research delivery; you make the dream of a better and healthier future for all a tangible reality. And if you’re a jobbing Doctor, Nurse, AHP and you’re reading this… go talk to your R&D team, because there are a lot of trials on the horizon, and we need you!

As the old adage goes, it takes a village.

P.S. The UCL Joint Research Office has published a series of blog and video from research staff – take a look.

Author

Adam Smith was born in the north, a long time ago. He wanted to write books, but ended up working in the NHS, and at the Department of Health.  He is now Programme Director at University College London (which probably sounds more important than it is – his words). He has led a number of initiatives to improve dementia research (including this website, Join Dementia Research & ENRICH), as well as pursuing his own research interests. In his spare time, he grows vegetables, builds Lego, likes rockets & spends most of his time drinking too much coffee and squeezing technology into his house.

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