FACILITATE’s main objective is to help return the clinical trial data to the study participants, ready for reuse in either further research or in health care practice.

Almirall is participating in FACILITATE (FrAmework for ClInicaL trIal participants’ daTA reutilization for a fully Transparent and Ethical ecosystem), a patient-driven Innovative Medicines Initiative (IMI) project that aims to create a framework for access and reutilization of clinical trial participant data. 

FACILITATE’s main objective is to help return the clinical trial data to the study participants, ready for reuse in either further research or in healthcare practice, improving the current situation where clinical data are isolated in separate repositories and cannot be used outside the clinical trial.

Almirall's main contribution focuses on providing expertise in privacy and pharmaceutical law issues, as well as in developing guidance, standards, and recommendations for the return of clinical trial data to patients. In addition, the company also contributes with its expertise in the specification of clinical trial use cases, stakeholder requirements, and the development of end-user tools.

FACILITATE is based on a patient-centered, data-driven technology platform with 27 partners from 17 EU and non-EU Member States. Participants include patient associations, hospitals, universities, innovative small and medium-sized enterprises, and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and with the Università degli Studi di Modena e Reggio Emilia as project coordinator. 

The project, which was approved by the IMI Joint Undertaking (European Commission and EFPIA) in 2021, has been launched this year together with the FACILITATE website.

“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,” says Diego Herrera, Almirall’s FACILITATE Project Leader, in a news release.

"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," adds Prof Johanna Blom, University of Modena-Reggio Emilia (UNIMORE) vice-coordinator of FACILITATE.

 FACILITATE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 101034366. The JU gets support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.