Welcome to the Clinical Trial database of the Menarini Group.
Clinical Trial Data Transparency
The Menarini Group is committed to enhancing public health trough responsible sharing of clinical trial data, in a manner that is consistent with the Principles for Responsible Clinical Trial Data Sharing released by the European and US pharmaceutical trade associations, EFPIA and PhRMA, referred to herein:
- Safeguarding patient privacy and informed consent
- Respecting the integrity of national regulatory systems
- Maintaining incentives for investment in biomedical research.
Registration and Disclosure of Clinical Trial Results
The Menarini Group publicly discloses information about all Menarini Group sponsored trials in public registries, such as ClinicalTrials.gov and other applicable websites as required, as well in our Clinical Trials Database.
The results summaries of the clinical trials sponsored by the Menarini Group are available on publicly-available databases such as ClinicalTrials.gov and other applicable websites as required, within a year following the end of the trial.
The policy on trials registration and sharing of results was adopted by the Menarini Group since 2006 for pre-registrative interventional trials (excluded ones in healthy volunteers) and progressively extended to post-registrative phase IV studies.
Sharing of Clinical Study Reports (CSRs) and Participant Level Data
Consistently with the Principles for Responsible Clinical Trial Data Sharing , since 2016 the Menarini Group is committed to share upon request from qualified scientist and medical researchers Clinical Study Reports (CSRs) and Participant level clinical trial data for medicines and indications approved in Europe and US, as necessary for conducting legitimate research.
CSRs are study reports that provide information on design and results of clinical trials.
Fully anonymised participant-level data refer to information on individual patients collected during a clinical study in compliance with the applicable Personal Data Protection Law.
The Menarini Group implemented a system to receive and review data requests from qualified scientist and medical researchers.
For more information on this system or to submit an application, please visit the dedicated section of our website.
The Menarini Group adheres to the principles set forth in the “JOINT POSITION ON THE DISCLOSURE OF CLINICAL TRIAL INFORMATION VIA CLINICAL TRIAL REGISTRIES AND DATABASES”, which represents the position agreed upon by the international pharmaceutical associations EFPIA (European Federation of Pharmaceutical Industries and Associations), IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), JPMA (Japanese Pharmaceutical Manufacturers Association) and PhRMA (Pharmaceutical Research and Manufacturers of America), with the aim of making information on Clinical Trials readily and easily accessible, in the context of transparency in Clinical Research by the Industry, with the commitment to providing patients and health personnel with all the relevant information on newly developed products.
The Menarini Group is committed to publish in the scientific literature results from all Menarini Group-sponsored interventional trials (excluded ones in healthy subjects, i.e. those studies without any therapeutic objective), irrespective whether the results are positive or negative. This commitment also apply to investigational medicines whose development programs have been discontinued.
The use of the medicinal products as it emerges from the data reported in our website may not be entirely in line with the indications currently approved by the competent regulatory authorities. The information given herein is not meant as medical promotion, nor it is meant to replace the advice of the physician, who is ultimately responsible for the choice of the most suitable treatment for the individual patient.
The Menarini Group has several alliances with other pharmaceutical companies. As a consequence, the Menarini Group may not have been the sponsor of all clinical studies for a product and therefore the results of such studies may not be included on our database. For any information about studies sponsored by our alliance companies, please consult other public registries such as ClinicalTrials.gov or EU Clinical Trials Register.
Please be informed that the links above will take you to a website the content of which has been designed in accordance with country specific laws and regulations