Case study: HARMONIE - First commercial study on the NIHR Associate Principal Investigator Scheme

The  study looks at how babies can be protected from serious illness due to rrespiratory syncytial virus (RSV) infection by comparing a single antibody injection, Nirsevimab, with no intervention. HARMONIE is a collaboration between Sanofi, its partner AstraZeneca, and the National Institute for Health and Care Research (NIHR), has now finished participant recruitment and is undergoing analysis. 

Dr Owen Hughes is a GP Partner at Cripps Health Centre and after seeing the team deliver the HARMONIE study,  he wanted to get involved in research. Following conversations with the Chief Investigator, Dr Royal, they found the Associate PI Scheme pilot. Together with the sponsor, Sanofi, they registered the study on the new pilot to include commercial studies on the scheme. 

The NIHR Associate Principal Investigator Scheme is an in-work training opportunity, providing practical experience for healthcare professionals starting their research career. The scheme aims to develop healthcare professionals to become the PIs of the future, giving them the skills needed to take on responsibility for the conduct of a research study at a site. Dr Hughes was the first Associate PI Trainee on the Associate PI Scheme commercial study pilot and is now nearing the end of his time on the scheme.  

The purpose of the commercial studies Associate PI Scheme pilot is to see if commercial studies can lend themselves to  Associate PI Trainees meeting the scheme competencies. The HARMONIE study is 1 of 7 commercial studies chosen for the pilot. The pilot aims to generate new investigators, mentoring from experienced PI’s, expanding the pool of researchers able to deliver industry research and capacity building. Also giving healthcare professionals the experience to understand what it is like to deliver on commercial studies.

The first baby to be immunised globally on the HARMONIE study happened at Cripps Health Centre in Nottingham by Nurse Manager Sue Belton and Lead Research GP Partner, Dr Simon Royal. 

The HARMONIE Research Study is looking at a new medicine which protects against RSV. RSV is one of the most common causes of hospitalisation in babies and young children, and can cause a variety of respiratory tract symptoms. The symptoms of RSV include: runny nose, fever, cough, trouble eating and drinking. In some babies and young children, the illness may move into the lungs and cause wheezing and difficulty breathing. In some instances, severe respiratory disease may require hospitalisation for support, such as oxygen.  

Dr Hughes says: “I have really enjoyed getting involved with research delivery as a GP. The training scheme is clear to follow, and the security of having a mentor for 6 months during the study has been fundamental to me understanding clinical research. I have felt supported throughout and I’m proud to say I have since become the PI of another study.”

Dr Simon Royal mentored Dr Hughes during the study, meeting regularly and sharing his experiences in clinical research. 

“It has been inspiring to see GPs getting involved in research delivery through the API Scheme. Not only has it given me the opportunity to teach, but it now means we have more available PIs at the practice and increases our capacity to do more research. Being a mentor for the first commercial study on the scheme has been a fantastic experience and I encourage other pharmaceutical companies to apply for the scheme.”

Participating healthcare professionals receive formal recognition of engagement in NIHR CRN Portfolio research studies through the certification of Associate PI status, endorsed by the NIHR and Royal Colleges. If you are interested in joining the Associate PI Scheme, you can:

•  Find out more about registering
•  Find out more about registering your study for the Associate PI Scheme

Alternatively please get in touch with our primary contact in the East Midlands, Alison Hill, Workplace Facilitator.