The Chiesi Clinical Study Register
The Chiesi Clinical Study Register contains updated and detailed information on the clinical studies we carry out – including their phase, status, and all related publications.
Notably, the Register includes the Clinical Study Report (CSR) synopses of 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.
We also encourage and support the submission for publication in scientificliterature 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. The Register includes all references to the related publications on peer-reviewed journals.
Data Sharing Registries
We also disclose the clinical protocol, study-related information and summary results of clinical studies sponsored by Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A. in global public registries.
Notably, we commit to disclose 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. within 12 months from completion of the study.
Data Sharing Principles
As a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Chiesi undertakes to set up guidelines and procedures to implement the principles for responsible clinical trial data sharing developed by EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA)
Through EFPIA, Chiesi also adopts mechanisms for sharing clinical trial information and results with participants of clinical trials, and the general public, in accordance with relevant laws.
As an example, Chiesi follows a process aimed at developing and publishing Lay Summary Results for studies sponsored by Chiesi Farmaceutici S.p.A. and Chiesi Italia S.p.A. This process adopts a voluntary approach, in accordance with EFPIA principles, except where a mandatory approach is required by EU regulations.
Request for clinical trial data
We commit 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 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 point is anonymized to protect personally identifiable information.
In order to request data, please visit the Chiesi Clinical Trial Data Request portal.