Providing support for a phase 2 study in patients with metastatic breast cancer in the UK and EU
Boyds provided services to assist an EU Sponsor with the set up and ongoing site management of a study in patients with advanced metastatic breast cancer in the UK and Spain.
This study assessed the safety and efficacy of a new combination of two existing medications, a small molecule chemotherapeutic and a biological. Both medications were considered to be IMPs as they were being used outside their licenced indication. The Boyds team completed the submissions (regulatory/ethics/radiation safety) efficiently, setting up the sites in parallel to the competent authority and ethics committee review enabling the sites to be ready for initiation and activation as soon as study approvals were received. The study contracts were negotiated by the Boyds clinical operations team and signed off by the Sponsor.
The patient recruitment into the study was managed by the CPM and the CRA team across 8 centres in each country, ranging from large hospitals (Val d’Hebron in Barcelona and The Christie NHS Foundation Trust in Manchester), to smaller, more local sites.
This study had very specific laboratory requirements and both blood and tumour samples were shipped to three different central laboratories in the UK and Spain. In addition, the eligibility criteria were driven by a central read out of MRI scans, requiring dedicated project management to ensure the scans were reported in an expedited manner.
Both Boyds and the CRO SOPs were used depending on the tasks that were being delivered. The contract review process was facilitated by the CPM in the UK and the CRA in France, working closely together, with multiple team meetings each week.
Impact and Outcomes
The study was a success with several patients showing a positive response to the treatment. Following the proficient delivery of this trial, the Sponsor awarded us a further study, which Boyds successfully delivered using lessons learned from the previous study.