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Clinical data sharing with researchers

Grünenthal will share patient- and trial-level data from clinical trials with suitably qualified scientific and medical researchers as necessary for conducting legitimate research.

Patient-level data refers to information on individual patients collected during clinical trials.

Trial-level data refers to clinical reports or parts of clinical reports (as defined in EMA/240810/2013) and/or trial-level data sets.

Requests for clinical data sharing will be accepted for interventional clinical trials which meet all of the following criteria:

  • Were conducted in patients.
  • Were sponsored by Grünenthal.
  • Had first protocol approval after 15 July 2014.
  • Were submitted as part of a successful application to the United States Food and Drug Administration, the European Medicines Agency, or a national competent authority of a European Union Member States, for a marketing approval or variation or extension.

See the List of Accessible Trials for a list of trials meeting these criteria. Researchers may also inquire about access to clinical data from trials not included in this list.

Requests for clinical data sharing will be subject to assessment and approval by a Grünenthal Board and then by an independent review panel (the Scientific Review Board, SRB). There is no appeal process for rejected requests.

Requests for clinical data sharing must be submitted by e-mail using the Grünenthal Research Proposal Form. For further details of the request assessment process, see Requesting Clinical Data Sharing.

Potential researchers may request the names of all SRB members together with curriculum vitae including information about any existing relationships between Grünenthal and the SRB members. Please send these requests by e-mail to ClinicalTrialPortal@grunenthal.com.

For the outcomes of past requests for clinical data sharing, see the list Outcomes of Requests for Clinical Data Sharing.