The relationship between the study participant and the site staff is of significant value for the patient who seeks support and understanding when both are managing disease and their participation in the clinical trial. The study site coordinator/study nurse plays a pivotal role in this relationship, and as such the retention.
By means of the regulation, the EU intends to limit the regulatory authority at national level. Shorter approval timelines are expected. With this the European Union aims to make Europe more attractive for study placement.CTR.
The ideal study patient is someone who is aware of what clinical research entails and what the benefits are for the society and potentially for the individual participant, before a trial is offered to him/her. These individuals have bought in to the idea of clinical trial participation before they face a health issue where trial participation is proposed. I expect this knowledge positively impacts the trial participant’s belief that this is the right thing to do, and as such also their engagement in the trial. The right country is identified by a balanced selection based on epidemiology data, regulatory framework and timelines. In addition, the in-country monitoring team will significantly contribute to the local trial success.
Focus on simplicity and a great communication network: digital applications should be integrated with the participant’s smartphone. The site staff and the helpdesk should be able to answer all the questions immediately.
Designing a recruitable and manageable protocol, the latter both from the Patient and Site perspective.