I work on the Sunflower study, a large national study looking at whether patients need a type of MRI scan before gallbladder removal. Our recruitment target is large - 7,457 patients over four years. Even before factoring in the limitations posed by Covid, we knew that trainee doctors would be essential to meeting this target in particular with the recruitment of urgently admitted patients.

My role as trainee coordinator is, we believe, unique to this study. I work part-time engaging trainees at our 50-plus recruiting sites. One of my main motivators for participation is the chance to take part in the NIHR Associate Principal Investigator (API) scheme.

The scheme was launched in early 2019, aiming to develop junior doctors, nurses and allied health professionals to become the PIs of the future. It provides formal recognition of engagement in NIHR Portfolio studies, endorsed by the NIHR Clinical Research Network and several medical colleges.

After a year-long pilot in the surgical specialty, when the Sunflower study was enrolled, the scheme is now also open to many other specialty areas including the NIHR urgent Covid studies.

Within the trainees participating in the Sunflower study, uptake to the API scheme is going very well, giving a noticeable boost to our recruitment numbers. But that isn't all the registered APIs do - they have contributed in a variety of ways, many of which help share the workload of consultant PIs and research nurses. The APIs help complete the study database, they can expedite the patient pathway, they increase local interest in the study, and stand in when other staff are unavailable.

Above all, our Sunflower study APIs can dramatically increase the recruitment of out-of-hours emergency patients, essential to our ability to answer the study question!

In turn, the APIs gain useful experience of how a large randomised controlled trial works on the ground. As well as improving their study recruitment skills, they build their teamwork and communication skills by training other staff, and giving presentations that boost their CVs.

A number of APIs have re-registered on the scheme following rotation to another hospital, to gain further experience via the Sunflower study. All this API involvement benefits patients too, due to a higher chance of being involved in research, which has been linked to better outcomes.

APIs have reported that the registration process is simple and quick. Following the transfer onto NIHR Learn this Summer, their six months on the scheme has more structure, their final checklist is easier to complete, and they can interact with other APIs on a forum.

Some feedback I've received from the APIs involved in the Sunflower study includes:

"Excellent scheme for getting health care professionals more involved in research!"

"Fantastic opportunity to take part in research and gain detailed experience and learning about what conducting a clinical trial truly entails”

"It has been great playing such a leading role while being fully supported by the research team. I have also enjoyed putting the Good Clinical Practice principles into everyday practice"

"I am learning skills that will help me as I progress in my career"

In terms of my role, the scheme has been a great advantage. It would have been a much bigger challenge to involve junior doctors in our study had it not been available as a mutually-beneficial reward.

For those who would like to read more, my colleague Marcus Jepson has had a paper published on trainee involvement in the Sunflower study, based on a number of interviews with APIs and PIs. It concludes that "trainees can contribute substantial activity to a large-scale multi-centre RCT".

Jane Collingwood
Senior Administrator Sunflower Study/Surgical Trainee Coordinator