Patient needs and expectations at the centre of the project

• FACILITATE is a project built on a patient-centred vision: it focuses on the needs and rights of the patients who take part to a clinical trial to dispose of their own data

• FACILITATE main goal is to develop a process to return data originated from a clinical trial to study participants for their use and re-use

• Why the re-use of this data is so important for patients? Because it allows them to play a central role in clinical trials strategy and design and in the medical decision-making

• Today clinical trial data are siloed in separate repositories without any possibility to be used beyond their original single-sided purpose.

• FACILITATE aims to overcome this current limitation, transforming the way patients will have access to clinical trial data in Europe.

• How? By defining which, when and how clinical trial data should be returned to study participants and integrated in their individual health records files or applications

• The whole data process, from collection of data to its destruction or anonymization, including its sharing and re-use, will be legally and ethically compliant and aligned with the patient voice

Patients involved from the beginning

All technical solution and legal and ethical compliant process can be viable only if patients are heard, involved, and committed to the project from the first phase

In FACILITATE, patient needs, and expectations will be elicited with the help of patient representatives, which are partners of the project, through relevant interviews, surveys, or questionnaires

All the critical points and patient preferences will be defined by patient representatives and then addressed to other stakeholders

Patients will validate who will be entitled to access their data and for which use


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