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Case study: Study Support Service - Optimising Delivery

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Study profile and summary

Lead Local Clinical Research Network: West Midlands
Study name: ACCEPT
Type: NIHR non-commercial Partner
Funder: Government
Number of sites: 14
Recruitment target: 200
Recruitment achieved: 611

The most common route for children to take medicine is orally. There are a number of challenges with this approach, including the stability of the medicine, and the palatability of the medicine too.

The European Medicines Agency has acknowledged that an internationally harmonised method to assess the acceptability of children’s medicines is yet to be developed, so there is a growing need to identify an age-appropriate tool to assess acceptability.

ACCEPT has used children’s opinions to shape this tool. The study sought to understand which existing oral liquid medicines are perceived as acceptable to paediatric inpatients aged 2-16 years, when considering taste alone.

“The reason the ACCEPT study has proved so successful is thanks to the enthusiasm and support of nurses. They made the study happen and we could not have done it without them.”

Network Impact

The study started out recruiting at University Hospitals Coventry and Warwickshire. However, concerns that ACCEPT would struggle to meet its 200 participant recruitment target led Chief Investigator Punam Mistry, and Principal Investigator Hannah Batchelor,
to seek Network support.

CRN West Midlands undertook a study review, which looked at the challenges facing ACCEPT and its ability to be delivered on time and to target. The review verified Punam’s original concerns that it would struggle to be delivered successfully at a single
site. The project was amended to a multi-centre study, following which CRN West Midlands helped to involve 14 NHS sites across the West Midlands that recruited 611 participants in total. Punam explains:

“I first met up with Claire Callens [CRN West Midlands Research Portfolio Manager and User Involvement Coordinator] around October 2015, since when she’s provided me with a lot of support towards the study.”

This support came in many forms, but Claire was of particular assistance in helping Punam navigate the complexities of ethics approvals. Punam continues:

“It was an exciting challenge, but I had no idea that setting up a study would take up so much time! I had a major learning curve in relation to ethics approvals, which were needed at each site.

“I was always able to turn to Claire for guidance. As soon as new sites came on board, I made arrangements to train nurses on site, as well as making amendments to our ethics application with Claire’s help.”

Insight

Punam is equally enthusiastic about the support of nurses across the West Midlands. She continues:

“The reason the ACCEPT study has proved so successful is thanks to the enthusiasm and support of nurses. They made the study happen and we could not have done it without them.”

Research nurse James Jones, who is based at the Princess Royal Hospital within Shrewsbury and Telford NHS Trust, was the study’s third highest recruiter. He says:

“It’s rare that we ask people for their opinions, especially children. ACCEPT was an amazing study because it gave children a voice and a chance to develop the medicines they were taking. All the nurses were like, “Wow”, what a great idea, so we felt we had to get involved.”

The ACCEPT team are now looking to share the findings of the study with the makers of the medicines reviewed. Punam is clear about the way forward:

“A smile is internationally accepted and understood. We need a tool to measure the acceptability of medicines for children that is equally accessible. We’ve verified it works within the West Midlands, hopefully this will be the same outcome internationally too.”

This work was conducted as part of the SPaeDD-UK project (Smart Paediatric Drug Development – UK, a project co-funded by Innovate UK and the contributing companies of AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Juniper Pharmaceuticals and Pfizer, http://www.paediatricscienceuk.com).