Clinical trials
Clinical trial transparency at Grünenthal
The sharing of health information is fundamental for the good functioning of healthcare services, for patients’ safety, and to advance research and improve public health. Grünenthal is committed to disclosing health information, including the results of Grünenthal-sponsored clinical trials.
Grünenthal publicly committed to the Principles for Responsible Clinical Trial Data Sharing issued in January 2014 by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). See the Grünenthal Public Disclosure Declaration to learn how Grünenthal is meeting these commitments today.
Visit the Grünenthal Clinical Trial Portal for information about Grünenthal-sponsored clinical trials. This searchable portal lists information by product, by the condition (the indication studied), by trial development phase, by status, and by trial identification number. It also provides useful links to information posted on publicly accessible registries and databases like ClinicalTrials.gov and the European Union Clinical Trials Register.
Managed Access Programs
For products that have not yet been approved, our focus is on the generation of clinical trial data to enable regulatory authorities to assess whether these new medicines satisfy the requirements for quality, safety and efficacy for registration and market authorisation purposes. Approval by regulatory authorities is the only accepted route for allowing medicines to be made more broadly available to patients.
However, patients with serious and/or life-threatening diseases or conditions may not be eligible for participation in a clinical trial, nor may there be other treatment options available. Under specific circumstances and in compliance with the requirements of applicable local laws and regulations, Grünenthal may make unapproved medicines, or medicines approved for a different indication, available to these patients at the request of a treating physician, authorities and/or Institutional Review Boards/Independent Ethics Committees, by conducting a Managed Access Program.
The requests for participation of a patient in a Managed Access Program can only be made by the treating physician of a patient and should be submitted via email to map@grunenthal.com.