Clinical Trial Transparency and Data Sharing
Conducting clinical trials and sharing their results are fundamental to clinical research. Transparent communication of findings not only advances scientific understanding but also builds trust among participants and the broader community. Chiesi Farmaceutici S.p.A. (Chiesi) is committed to Clinical Trial Transparency and Data Sharing.
As a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Chiesi commits to establishing guidelines and procedures for implementing the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing.
Clinical Study Registration and Posting of Summary Results
In accordance with the local legislative and applicable requirements on clinical studies, Chiesi discloses in public registries (e.g., ClinicalTrials.gov, EU Clinical Trials Register, CTIS portal) the Clinical Protocol and Study-related Information and the Summary Results of those clinical studies sponsored by Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A.
Furthermore, Chiesi commits to making available information regarding any phase 2-4 clinical trial, specific typologies of non-interventional studies, and clinical investigations on medical devices sponsored by Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A., that are not subject to a mandatory disclosure requirement in any Primary Registry part of the World Health Organization (WHO) Registry Network and that are initiated on or after 1st June 2018. This information is provided by means of the public registration in ClinicalTrials.gov and disclosure of Summary Results (e.g., posting on ClinicalTrials.gov, CSR synopses, structured summary data, etc.) within 12 months from completion of the study.
The Chiesi Clinical Study Register contains all clinical studies and publicly disclosed study-related and results-related information.
Sharing Clinical Study Report Synopses
Chiesi commits to sharing the Clinical Study Report (CSR) Synopses of those clinical studies sponsored by Chiesi Farmaceutici S.p.A., submitted to the Food and Drug Administration (FDA), European Medicines Agency (EMA) or National Competent Authorities of European Union Member States for any new medicine or indication approved for the first time in the United States and/or European Union after 1st January 2015, within 12 months after the approval.
Chiesi provides the CSR Synopses consistent with the need to protect patient privacy, publication rights, and commercially confidential information through appropriate redaction.
The CSR Synopses are made available on the Chiesi Clinical Study Register.
Publication of Clinical Study Results in Scientific Literature Journals
Chiesi encourages and supports the submission for publication in Scientific Literature Journals of results from at least all phase 3 clinical trials sponsored by Chiesi Farmaceutici S.p.A. and any clinical study results of significant medical importance, regardless of the outcome.
References to the peer-reviewed journal publications of Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A. clinical studies results are made available on the Chiesi Clinical Study Register.
Sharing Lay Summary Results
Chiesi, as a member of EFPIA, adopts mechanisms to share clinical trial information and results with participants in clinical trials and the general public, consistently with applicable laws.
Therefore, Chiesi follows a process aimed at developing and publishing Lay Summary Results for Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A. sponsored studies according to:
A voluntary approach, in accordance with the EFPIA principle, and
A mandatory approach for interventional trials falling within the scope of application of the European Regulation no. 536/2014 on Clinical Trials and for the Clinical Investigations on Medical Devices falling into the scope of application of the European Regulation no. 745/2017 on Medical Devices.
Sharing Clinical Data With Qualified Researchers
Chiesi commits to sharing with qualified scientific and medical researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol, and the full CSR of Chiesi Farmaceutici S.p.A.-sponsored interventional clinical trials in patients for medicines and indications approved by EMA and/or FDA after January 1, 2015.
Chiesi provides access to clinical trial information consistent with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.
For more information on this process or to submit a request for Chiesi Farmaceutici S.p.A. clinical trial data, please visit the Chiesi Clinical Trial Data Request Portal.