Clinical data sharing with researchers
Grünenthal will share clinical information, i.e., clinical study reports and clinical data from interventional clinical trials with suitably qualified scientific and medical researchers as necessary for conducting legitimate research.
Requests for Access to Clinical Study Reports
Clinical study reports refer to reports following the ICH E3 format. All protected personal data in these reports will be irreversibly masked before sharing.
Requests for access to clinical study reports (or parts thereof) will be accepted for reports for clinical trials with first protocol approval from 2003 onwards.
Requests for access must be submitted by e-mail using the Grünenthal Research Proposal Form. Requestors will be required to sign a confidentiality agreement and to provide evidence of their qualifications and experience before receiving the clinical study reports.
For the outcomes of past requests for access to Clinical Study Reports, see the list Outcomes of Requests for Access to Clinical Study Reports and Clinical Data.
Requests for Access to Clinical Data
Clinical data refers to patient- and trial-level data.
- Patient-level data refers to information on individual patients collected during clinical trials.
- Trial-level data refers to aggregated trial-level data.
Requests for access to clinical data will be accepted for clinical trials which meet all of the following criteria:
- Were interventional clinical trials conducted in patients.
- Were sponsored by Grünenthal.
- Had first protocol approval after 15 July 2014.
- Were submitted by Grünenthal in support of licensed treatments in the European Union or the United States.
See the List of Trials Accessible for Data Sharing for a list of clinical trials meeting these criteria. Requests for access to clinical data from trials not included in this list will be considered on a case-by-case basis.
Requests for clinical data sharing must be submitted by e-mail using the Grünenthal Research Proposal Form. Requestors will be required to sign a confidentiality agreement and to provide evidence of their qualifications and experience before receiving the requested clinical data.
Requests for access to clinical data will be subject to assessment and approval by a Grünenthal Board and then by an independent Scientific Review Board.
For clinical trials co-sponsored by another company, sharing will also be subject to agreement of the co-sponsor. There is no appeal process for rejected requests.
For the outcomes of past requests for access to clinical data, see the list Outcomes of Requests for Access to Clinical Study Reports and Clinical Data.
For further details of the request assessment process, see Requesting Access to Clinical Data.
The Scientific Review Board
The Scientific Review Board members are:
- Prof. Dr. Jordi Serra, Consultant, Clinical Neurophysiology, King’s College Hospital, London, UK and Co-owner and Chief Scientific Officer, Neuroscience Technologies, Barcelona, Spain & London, UK.
- Dr. Bruno Boulanger, Chief Scientific Officer, PharmaLex Belgium, SA., Mont-Saint-Guibert, Belgium.
- Neil Betteridge, Director, Neil Betteridge Associates, London, UK.
The Scientific Review Board members must be free of any conflict of interest that could interfere with their ability to serve on the board in an impartial and objective manner and all interactions between Grünenthal and the board members must comply with the Grünenthal policy on Healthcare Interactions.
To view the Scientific Review Board member curriculum vitae; please send a request to ClinicalTrialPortal@grunenthal.com.