Almirall has announced its plans to participate in the latest patient-driven project launched by the Innovative Medicines Initiative (IMI), referred to as the FrAmework for ClInicaL trIal participants’ daTA reutilisation for a fully Transparent and Ethical ecosystem (FACILITATE).
The project aims to build a framework for access and reutilisation of clinical trial participant data in order to create an entirely compliant and ethical ecosystem. The project, which received approval from the IMI Joint Undertaking (European Commission and EFPIA) in 2021, has been initiated this year in tandem with the FACILITATE website.
The primary goal of FACILITATE is to return clinical trial data to those taking part in studies, making it ready for reuse in future research or in healthcare practice. Moreover, it is focused on improving the current status quo, whereby clinical data is isolated in separate repositories and is prohibited from being used outside of the clinical trial.
The company aims to offer its expertise in privacy and pharmaceutical law issues, while developing guidance, standards and recommendations for the safe return of clinical trial data to patients.
Almirall also contributes its knowledge in the specification of clinical trial use cases, stakeholder requirements and the development of end-user tools.
Commenting on the plans, Diego Herrera, Almirall’s FACILITATE project leader, said: “The launch of FACILITATE further advances patient empowerment in clinical trials. At Almirall, we are excited to contribute to this patient-driven IMI project with our solid experience in clinical trials and our commitment to ethics and transparency. This project is fully aligned with our patient-centricity strategy aimed at improving their quality of life.”
FACILITATE is based on a patient-centred, data-driven technology platform with 27 partners from 17 EU and non-EU member states and is planned to last four years. The project coordination will be overseen by Università degli Studi di Modena e Reggio Emilia (UNIMORE), while those involved come from patient associations, hospitals, universities, innovative small and medium-sized enterprises and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The project will ensure that the entire process, beginning with the collection of data to its destruction or anonymisation – including its sharing and re-use – complies both legally and ethically, while supporting study participant, hospital and industry voices.
Professor Johanna Blom, UNIMORE vice-coordinator of FACILITATE, said: “FACILITATE is an IMI-JU project that builds on the collaborative efforts of many public and private partners and has the purpose to manage the return of individual clinical trial data in a trusted legal and ethical environment.
“Leveraging on a patient’s needs, FACILITATE aspiration is to develop a prototype process which enables the return of clinical trial data during and after the clinical trial and allows for the secondary use of that data.”