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Case study: Rococo: Real-world research in a pharmacy setting

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Clinical need

Approximately one in five people in the UK suffer from acute cough over the winter season. This makes it one of the most common reasons to visit a GP in the colder months, and subsequently costs the NHS around two billion pounds per year. 

Many patients opt to seek relief from acute cough from over-the-counter (OTC) treatments, but very little research has been conducted into the effectiveness of OTC cough medicines; many of which have been described as ineffective by patients. Some trials into acute cough have been attempted in hospitals in the past, however, their success has been limited. This is likely to be related to the choice of setting, as cough patients rarely present at hospital, resulting in poor participant recruitment to the trials.

In 2015, the Rococo study took a different approach and, at the time of delivery, it was one of the largest multicentre, randomised controlled clinical trials in participants with coughs. The trial compared a branded OTC cough medicine ‘Unicough’ with a simple cough linctus to see if was capable of demonstrating significant reductions in acute cough symptoms. It successfully recruited 163 patients within just four months.

 

The community setting

Rococo’s recruitment success was primarily down to its real-world approach.  Instead of focussing on secondary care it looked at where patients first seek relief for an acute cough and, as a result, it  was conducted exclusively through community-based sites. This included 14 pharmacies and four GP surgeries in England and resulted in Rococo being the first UK study to recruit participants seeking cough medicines from pharmacies.

Professor Surinder Birring, Consultant Respiratory Physician at King’s College Hospital London and Chief Investigator for the study, explains its significance for the future of community-based health research:

“This was an important study for community-based research as it was the first cough study to be done in a pharmacy setting; the most appropriate setting for the type of illness being studied. At the outset it was completely unknown how the trial was going to run. There were some initial concerns around gaining ethical approvals and some uncertainties around whether patients would want to be involved.  However, the ethics board were very supportive of our requirements, and we concluded with results that clearly demonstrate the appropriateness of pharmacies as a research setting.”  

As outlined by Professor Birring, not only did the community-based approach maximise access to the target patient population, it also meant that study participants more closely resembled the broader population seeking cough medicines. This lead to the generation of real-world data - more accurate and applicable results in terms of how effective the medicine is in the ‘real-world’ as opposed to a controlled clinical trial setting.

 

NIHR support

The recruitment success of Rococo was also in part down to support provided by the NIHR Clinical Research Network. Sinead Collinge, Industry Operations Manager for the West Midlands Clinical Research Network, explains how her team supported the study:

“The NIHR contributed significantly to efficient site identification and selection. We have a number of pharmacies in the area that are ‘research-ready’. By this we mean that they either have Royal Pharmaceutical Society ‘Research Ready’  status or they are already engaged in clinical research and have worked with the NIHR Clinical Research Network previously.” 

The Royal Pharmaceutical Society runs a ‘Research Ready’ accreditation scheme for pharmacies in the UK. It requires a pharmacy to have a dedicated research lead and for all staff to have undertaken Good Clinical Practice (GCP) training which is mandatory for employees who will help to deliver a study. There are currently over 100 pharmacies registered. Sinead continues:

“Having access to research ready pharmacies really helps when it comes to getting a study up and running in a pharmacy setting. The staff already understand the principles that make the study run smoothly, such as how to collate, store and submit the data. But in addition these pharmacies really understand the unique benefits that delivering research in the community can bring. They are always willing to contribute to studies, in fact, the problem we often have is that we don’t have enough studies to offer them.”

Julie Shenton is the Lead Pharmacist and Continuous Improvement Lead for West Midlands LCRN. Julie is a strong advocate for clinical research and explains more about what advantages community pharmacies have to offer when delivering clinical research:

“Community Pharmacies are more accessible than other healthcare providers. People with long term conditions see the pharmacist more frequently than they see their GP, which means we have a different level of access to those patients. But also there are more pharmacies than GP surgeries and hospitals and we have longer opening hours. Plus people can just pop into a pharmacy without an appointment. I think there is a statistic that says about 96% of people can get to a pharmacy either by foot or public transport in less than 20 minutes.   

“We can also access harder to reach patient populations and different patient populations to GPs. For example, some people might not know if they need to visit a GP and may instead visit a pharmacy for advice about what they believe to be minor ailments. So it may be that we can access a patient population at a different stage of their disease progression. Community pharmacies certainly have a lot to offer and we’d like to see more researchers tapping into that resource.”

Results

Rococo closed to recruitment April 2015 with good data completion, having recruited 163 participants. The study results demonstrated that, although there was little change in cough severity,  the OTC cough medicine ‘Unicough’ was associated with greater reductions in acute cough symptoms than a simple linctus generally prescribed by GPs.

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