Case Study: Feasibility project- Asthma randomised clinical trial

A leading pharmaceutical organisation commissioned us to supply an accurate feasibility study for a new clinical trial. They had previously asked sites for specific patient numbers but were unhappy with the accuracy to enable appropriate target setting for this time critical study.

The organisation was concerned that there were not enough patients to be able to recruit for the study.

Our clinical team worked with the sponsor to not only run accurate patient number searches but also cleaned the searches at site using experienced Research Nurses. The lists were then adjusted using an algorithm to estimate the actual number of patients that would:- respond to mailings, book appointments via the telephone, DNA or attend a recruitment clinic. These were then randomised.

We then proposed an additional number of sites which were in many cases research naïve, meaning they could focus on this study and not multiple competing studies.

• Full feasibility completed ahead of the 8 week target
• Full practice feasibility using cleaned lists and resource/target estimation that were considerably more accurate
• Creation of a new practice list and identification and engagement at the site, including creating subject lists
• Extensive collaboration with the National Institute of Health Research network and relevant CCGs to identify new sites and Practice Investigators