What about Ethics?
The MILESTONE study is being performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
GCP-trained personnel conducts the study and ethical approval for the trial and all patient information are in place since the beginningof the study. All data is stored securely and anonymised in accordance with national and European legislations.
Any substantial protocol amendments (e.g. changes to eligibility criteria, outcomes, analyses) are communicated to relevant parties and approvals sought as required prior to implementation.
An independent Scientific Clinical and Ethical Advisory Board (SCEAB) monitors the proper conduct of the trial and other MILESTONE activities. Furthermore, the MILESTONE project incorporates an ethics work package (WP6) whose work has influenced the design of the trial, intervention and selection of assessment tools. Moreover, from the beginning, the WP6 team has put a focus on ethics related to various aspects of the MILESTONE study.