DATASHARING

The Menarini Group fully support responsible sharing of clinical trial data for legitimate, verified scientific research purposes.

Upon request from qualified scientist and medical researchers, the Menarini Group is committed to share clinical trial data from the Menarini Group sponsored trials in patients – including de-identified participant-level data and Clinical Study Reports (CSRs) – for medicines and indications approved in Europe and US, consistently with the EFPIA_PhRMA Principles for Responsible Clinical Trial Data Sharing.

The Menarini Group will provide information for trials that meet the following criteria:

• The clinical trial sponsor is a Menarini Group company
• The product and the relevant indications have been authorized by the regulatory authorities in Europe/US (or, if not, two years have elapsed since the study completion)
• The marketing authorization holder of the product is a Menarini Group company
• The Menarini Group has the right to disclose such information (if applicable, in case of co-development/license agreements with other Companies)

Data requests will be assessed to verify that the criteria regarding the qualifications of the requestors and the scientific merit and legitimacy of the research purpose are met.

Therefore, the application should include, and will be evaluated on the basis of, the following information:

• a clear indication of the data requested, as well as a description of the research project and its underlying rationale
• the analysis plan
• the publication plan
• a mention of any actual and potential conflict of interest, including whether the intended use of the requested data is for competitive purposes
• the source of any research funding

All requests will be reviewed internally by a qualified panel of Menarini Group experts (Scientific Secretariat) and then passed to an Independent Review Committee (IRC) of external experts for further review.

Independent Review Committee’s (IRC) Members

• Claudio Borghi, MD, Professor of Internal Medicine, University of Bologna
• Pier Luigi Canonico, MD, Pharma science Department Director, University of Eastern Piedmont - Novara
• Alberto Zanchetti, MD, Professor Emeritus of Internal Medicine, University of Milan

On the basis of the assessment performed by the above mentioned Review Committees (Scientific Secretariat and Independent Review Committee), the Menarini Group will make a final decision with regards to the data request received.

In the event that the application is accepted, actual access to the data shall be subject to the applicant entering into a Clinical Trial Data Sharing Agreement (DSA) with A. Menarini Industrie Farmaceutiche Riunite S.r.l., whereby the applicant undertakes, inter alia:

• not to use the data for any purposes other than the research project described in the application (e.g. industrial or commercial purposes)
• not to disclose or transfer the data to any third party
• not to re-identify, or seek to re-identify, any research participants

Prior to being shared with the applicant, CSRs will be redacted to remove any confidential information or information that could lead to re-identification of research participants.

Following his/her acceptance to enter into the DSA, the applicant will be granted access to data trough a protected web-based system in accordance with the DSA.

The Menarini Group reserves the right to reject, at its sole discretion, any application. However, in case an application is not approved, the applicant will receive an explanation for the rejection.

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