A unique, challenging and rewarding role – a blog by Suja Subin, Advanced Clinical Practitioner

I am an Advanced Clinical Practitioner (ACP) in clinical research at NIHR Manchester Clinical Research Facility (CRF), which part of Manchester NHS Foundation Trust (MFT.)

Since the beginning of my nursing career in India, I was inspired by the many journal articles by nurse prescribers and advanced practitioners that I read. I moved to the UK to pursue such a role; joining the CRF as a clinical research nurse in 2005.

Clinical research is a fascinating area of health care where scientific enquiry becomes future treatment and care. As nursing has evolved over the years to reflect the health care priorities of the population, clinical research nursing has become a specialised area of practice that helps shape future medicine.

Clinical research nurses exercise a lot of autonomy in practice; by leading a clinical trial from its planning phase, all the way through to delivery.

Pioneering the ACP role in clinical research

As a clinical research nurse, there were some actions that I couldn’t undertake. For example, performing advanced physical examinations, ordering diagnostic tests and prescribing investigational medical products – which would ordinarily be the responsibility of the Principle Investigator (PI) or delegated medic. However, with an increase in demand on the service and with research and innovation a growing government priority, Manchester CRF saw an opportunity to develop what was then known as an advanced nurse practitioner (now known as ACP) role in clinical research. This idea was based on evidence from other healthcare sectors, where successful implementation of the role led to effective use of resources, flexibility in service and continuity of care. Through Manchester CRF’s vision for pioneering the role within clinical research, I am lucky to be one of the first ACPs trained from a Clinical Research Facility in the UK, after successfully completing an MSc in Advanced Practice (Health and Social Care) from Salford University in 2013.

An important aspect of the ACP role is that it can be shaped to address complex and dynamic healthcare system needs. In clinical research, the role is replacing a medic or research fellow. In the majority of the clinical trials facilitated by the CRF, my role is as a Sub Investigator. This means that within a particular study, I am responsible for medical review and safety of patients, as well as performing specific tasks including consenting patients, performing complex examinations, reviewing adverse events and much more.

My role has significantly impacted the delivery of the trials at Manchester CRF, including an ongoing study into Huntington’s disease. The study started at the CRF as an early phase first in human clinical trial targeting the underlying cause of Huntington’s Disease using a novel therapy. I am a Sub Investigator for the study, and as such able to perform a number of complex assessments required by the trial. I can also prescribe the trial drug – which is given to participants directly into the spinal canal every eight weeks.

Additionally, I also lead the Workforce Education and Development (WED) group at the CRF. The purpose of this group is to develop the workforce to proactively promote a culture of lifelong learning and enable the delivery of high standards of education, research, quality and clinical care in the Facility.

I believe that my role is quite unusual with its own challenges. For example, some pharmaceutical companies were reluctant to accept a non-medic performing advanced clinical skills at first, but through ongoing dialogue we have managed to overcome these barriers. I am very fortunate to be at MFT, as I was supported by medical colleagues and managers to develop the role and challenge some of the initial decisions taken by pharmaceutical sponsors, leading to changes which have in turn provided flexibility and continuity of clinical care and research delivery.

I am so proud to be a pioneer of the ACP role, by working beyond the boundaries of traditional clinical research nursing; bringing extended scope of practice and career progression to clinical research nurses to improve health outcomes for our patients and community.