Chiesi Clinical Trial Registry and Database

The Chiesi Clinical Trial Registry and Database (CCTRD) provides an easily and publicly accessible repository of basic information about all Phase III and Phase IV clinical trials sponsored by Chiesi, in addition to the relevant scientific communications and publications. Phase II clinical trials may also be included in case data from these trials are deemed useful for public knowledge.

In accordance with international Good Clinical Practices (GCPs), Chiesi-sponsored trials are those for which Chiesi is ultimately responsible for all the aspects of the study, even if some or all of these activities are outsourced.

The appropriate use of Chiesi’s medicinal products is guided by their relevant approved prescribing information, e.g. their Summary of Product Characteristics (SmPC) in Europe or Product Information in the US) and the CCTRD does not intend to substitute this information.

The intention of the Registry part of CCTRD is to provide scientific non-promotional information about ongoing confirmatory clinical trials sponsored by Chiesi.

The Registry will include clinical trials initiated since 1 July 2005. Trials included in the Registry shall also be published on the independent international database maintained by the US National Library of Medicine (www.ClinicalTrials.gov).

For healthcare advice, the interested members of the public or patients should consult Healthcare professionals.

The Database part of CCTRD will include clinical trials completed after 1st January 2006 and conducted on a drug that is approved for marketing and commercially available in at least one country, irrespective of outcome.

Information in the Database will be posted within one year after the drug is first approved and commercially available or, for trials completed after this initial approval, within one year of trial completion (i.e. of final clinical trial report available), unless such posting would compromise publication in a peer-reviewed journals, contravene national laws or regulations or prevent intellectual property rights to be exploited.

Additionally, Chiesi may be required to withhold certain trial summaries to comply with confidentiality provisions in agreement with other parties