All partners have collaborated in the design and setup of the clinical trial, including the development of the clinical protocol. Notably, the involvement of patient representatives at this early stage has ensured a patient-centred approach to the research. In addition, the selection of recruiting sites and the patient commitment per clinical partner have been defined. Foundational plans have been established to support the proper implementation of the trial, including the trial management plan, data management plan, monitoring plan, and sample management plan. Ethical and regulatory approvals have been obtained for Austria, Israel, and Spain. The site in Israel has been activated, along with ten sites in Spain. In Austria, site activation visits have been scheduled.
Regulatory approvals for Ireland, Italy, France, and Germany are still pending due to discrepancies between national regulatory agencies. However, approval is expected at the beginning of the next reporting period, as all required documentation has already been submitted. During this reporting period, 76 samples have been analysed using HER2DX, and 61 patients have been randomised and enrolled in the trial.
Furthermore, the Statistical Analysis Plan and Data Management Plan have been finalised, outlining the procedures for analysing and managing the data. Two deliverables summarising current clinical guidelines have been submitted, along with a survey designed to gather input for the Health Technology Assessment (HTA) study. The Patient Advisory Board (PAB) has been established, including two representatives from each participating country. The PAB has reviewed patient information materials and provided valuable feedback. Additionally, methodologies to assess patient experience within the DEFINITIVE trial have been defined and delivered.
