Data Sharing and Clinical Trial Principles
Running clinical studies and obtaining results is what clinical development is all about. Sharing results is very important too. Therefore, 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 undertakes to set up guidelines and procedures to implement the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing
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., which are not subject to a mandatory disclosure requirement in any Primary Registry part of the World Health Organization (WHO) Registry Network and which 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.
All clinical studies and their study-related and results-related information publicly disclosed are made available on the Chiesi Clinical Study Register.
Chiesi commits to sharing the Clinical Study Report (CSR) Synopses of those clinical studies sponsored by Chiesi Farmaceutici S.p.A., submitted to 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 consistently 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.
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 journals 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.
Chiesi, as member of EFPIA, adopts mechanisms through which sharing clinical trial information and results with participants to 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 EFPIA principle, and
- a mandatory approach for the interventional trials falling into 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.
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Studylevel 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 1st January 2015.
Chiesi provides access to clinical trial information consistently 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.
Resources and useful links