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Case study: The Associate Principal Investigator Scheme in action

“I now have a deeper understanding of how research is delivered as well as experience in recruiting patients.”

The Associate Principal Investigator (PI) Scheme is a six month in-work training opportunity, providing practical experience for healthcare professionals starting their research career.

People who would not normally have the opportunity to take part in clinical research in their day to day role have the chance to experience what it means to lead and deliver a NIHR portfolio trial at a local level, under the mentorship of an enthusiastic local Consultant Principal Investigator (PI).

Participating healthcare professionals receive formal recognition of engagement  in National Institute for Health Research (NIHR) Portfolio research studies through the certification of Associate PI status, endorsed by the NIHR and Royal Colleges. 

The scheme is open to any doctor-in-training, nurse or allied health professional, which is what led Rory Morrison to seek out the Associate PI scheme on the PROFHER 2 study.

The PROximal Fracture of the Humerus: Evaluation by Randomisation Trial no. 2 (PROFHER-2 Trial) Chief Investigator Professor Amar Rangan is a champion of research and has ensured the trial is affiliated with the Associate PI scheme. 

The study is investigating fractures of the proximal humerus which are common in people over 65 years of age who have had a fall. When the bone is broken into more than two parts it is considered complex and there are three treatments that are regularly used: hemiarthroplasty, reverse shoulder arthroplasty, and non-surgical care. Hemiarthroplasty involves replacing only the broken 'ball' of the joint and reverse shoulder arthroplasty replaces both the ball and socket, but replaces the ball with a socket and the socket with a ball (hence ‘reverse’). Non-surgical care is where the arm is supported in a sling to allow the broken bone to heal naturally. It is not known which of these is the most effective treatment.

PROFHER-2 will assess whether reverse shoulder arthroplasty is more effective than hemiarthroplasty for complex fractures of the proximal humerus and if these methods are more effective than non-surgical treatment. This is a multi-centre randomised controlled trial where patients will receive one of these treatments and will also receive physiotherapy. The study aims to randomise 380 patients, 152 to each of the surgical treatments and 76 to the non-surgical treatment. The primary outcome that will be measured is the change in the Oxford Shoulder Score after 24 months. The associated costs of these treatments to the NHS will also be evaluated.

Mr Rory Morrison, an orthopaedic registrar, is an Associate PI for the ProFHER-2 trial and through taking part in the scheme he has become integrated into the research team. Mr Morrison said: “The Associate PI scheme is a great way to learn about running a clinical trial and to be given appropriate study responsibilities. I have developed my research skills and am integrating these in my day-to-day clinical practice. Attending trial management meetings has also given me an insight into some of the challenges of coordinating a multicentre trial, particularly in the current climate in the NHS.

“I now have a deeper understanding of how research is delivered as well as experience in recruiting patients.” 

Professor Amar Rangan, Chief Investigator of the PROFHER-2 study from South Tees Hospitals NHS Foundation Trust said: “I am delighted to have had Mr Morrision take part in the Associate PI scheme for the study. 

“I am always keen to support junior doctors who are interested in research to play an active role in study delivery and this scheme offers them practical and valuable experience to conduct high-quality clinical research.” 

Find out more about the Associate PI scheme.