Welcome to the second issue of the Refractory Asthma Stratification Programme (RASP-UK) newsletter. We are now 8 months into the programme and we can start to bring you regular meaningful updates on our RASP-UK programme process and related subjects through the newsletters. With the first patient screenings and randomisations taking place and over the next few months we are looking forward to seeing many more pa%ents being recruited

On 20 May 2016 Professor Heaney attended the first RASP-UK review meeting at the MRC. The purpose of the meeting was to report on the progress we have made since RASP-UK officially started on 20 October 2015 and whether or not we were managing to meet our defined programme metrics. The MRC Monitoring Group agreed that the consortium had made a strong start and had an excellent governance model in place. Members of the group were pleased with the amount of work that we achieved ahead of signing the consortium agreement. The general opinion was that this demonstrated good planning and highlighted the enthusiasm of partners to work together. The Group noted that our consortium was failing to achieve two of the programmes objectives for Milestone 1 but was reassured by the mitigation plans that were in place to correct for the current issues. These objectives are:

• Objective 2. Acceptable recruitment to inflammatory biomarker stratification study target
• Objective 4. Identification of novel biomarkers from UBioPred. Acceptable level of recruitment to SoMOSA study

The group questioned the use of our composite T2 biomarker strategy (FeNO, blood eosinophils and perios%n) rather than using individual biomarkers. The team explained that as outlined in the initial application, the combination of three factors was more predictive of exacerbation than the individual biomarkers and planned some further analysis of this in other datasets. In further discussion, the members commented that an appropriate health economic assessment will be an important aspect of this defining utility of this type of approach in the clinic. The Group also noted the following:

• Loss of the cash contribution from Janssen due to their withdrawal from the consor%um
• The importance of consortia being sufficiently flexible to appropriately respond to new advances, for example, changes in therapies, technologies, and mechanistic understanding, asking how we might respond to these changes

The Monitoring Group concluded that the consortium appears to function as a coherent and well balanced team and that the project was progressing well. They recognised that involving a professional Contract Research Organisation like Niche to coordinate activities and maintain delivery schedules appeared to be contributing to the successful delivery of the project. Our next review meeting will take place on Friday 18 November 2016.

References

1. RASP-UK consortium newsletter #2
2. www.rasp.org.uk