CRN West Midlands - Dermatology Trial Success in Primary Care
An antimicrobial cream for the treatment of impetigo
Three of our regional GP Practices took part in this trial, led by Dermal Laboratories Ltd between 2015 and 2018. Recruitment was opportunistic and our GP practices recruited 68 patients, all exceeding their recruitment target. Practices utilised their own clinical and clerical teams to set up and deliver this interventional study.
This trial was a multicentre, randomised, double-blind comparative study of a topically applied investigational product, IPTG Cream, in the treatment of impetigo in adults, children and infants over the age of 18 months, using Fucidin Cream as an active control. 273 patients were enrolled nationwide at 28 GP Practices.
Whilst 75% of patients treated with IPTG Cream were classed as clinical success at their end of trial assessment, this performance was not sufficient to demonstrate that IPTG Cream is efficacious in the treatment of non-bullous impetigo compared to 84% of patients treated with Fucidin.
Local experience of delivering a dermatology commercial study in Primary Care
Spring Gardens (Target 10, recruited 15)
“Overall the experience was positive although meetings were more frequent and lengthier than we would normally expect in a busy General Practice day so considerable time was required to do the study.”
Sherbourne (Target 5, recruited 18)
“Well set up and managed study with good communications between all parties - that always makes things smoother and easier at site”
Atherstone (Target 10, recruited 35)
“Overall, we have, enjoyed working with Dermal and developed a good working relationship with them - we look forward to working with them again in the future!”
Atherstone in particular had exceptional recruitment rates which were noted by the Network's Industry team
“Dr Gooding and his team have consistently recruited to this challenging and opportunistic trial and have managed to enrol 35 patients making them our highest recruiters. The next highest figure is 18 and the average is 5.5.
"The set up and dedication to research, as a business model or otherwise, has greatly benefited the sites ability to recruit to this trial”
Feedback from the sponsor Dermal has also been very positive:
“Over the three surgeries they recruited collectively 68 out of the study total of 273 patients randomised to our study. It was noticeable that this success in quality recruitment was down to collaborative team working within the individual surgeries along with engagement in research of their patients.
"The Quality of Data collected within a study is an area we would like to highlight as being imperative for any surgery to seriously consider when taking part in any commercial studies. Whilst recruitment is a metric easily recorded, it is the quality of the data collected from these recruited patients that is equally important to a sponsor as this is what is reflected in the study results. Hence study staff should consider whether their patients are likely to comply, attend and understand the importance of protocol/study adherence.
“Dermal also certainly benefited from direct communication with the above site teams and now will consider putting sites within a CRN area directly in contact with each other following receipt of expressions of interest.”
The practices that conducted this study, and conduct commercial research everyday, have something in common; a well resourced research team. These are skilled members of staff with clinical, IT and project management skills who volunteer their time out of their schedules to support these studies. As commercial studies are well reimbursed, practices can quickly build an infrastructure to support commercial research in the future.
The CRN Industry Team can support interested GP practices to develop their own research team, and express interest in and conduct commercial studies. We offer a range of training sessions to support new sites and will proactively work with practices to identify suitable commercial studies. If you have any questions or are interested to learn more please contact us on: firstname.lastname@example.org