Registry and Results
Almirall will make public clinical study information in a manner that is consistent with applicable national laws and the rules governing personal data privacy and the protection of intellectual property rights.
Information pertaining to clinical studies will be disclosed by means of recognized public databases such as Clinicaltrials.gov in the USA, and EudraCT in the European Union (EU).
Click the link below to view basic information on the registration and results of Almirall's ongoing clinical trials:
The Almirall transparency policy follows the recommendation of the European Federation of Pharmaceutical Industries and Associations (EFPIA) / Pharmaceutical Research and Manufacturers of America (PhRMA) Joint Position Papers on the Disclosure of Clinical Trial Information via Clinical Trials Registries and Databases and the Principles for Responsible Clinical Trial Data Sharing.
Therefore, it is Almirall's commitment to implement processes and systems that facilitate any study data request made on or after January 2014 from qualified scientific or medical researchers, for medicines and indications approved in the USA and the EU on or after January in 2014.
Any clinical data request should be accompanied by a research protocol proposal and (1) include a commitment to the future publication of the results, (2) ensure anonymity of patient data and (3) respect Almirall's commercially confidential information. Almirall's "Term of Use" agreement must be signed before clinical data may be accessed.
To facilitate clinical study data sharing as per Almirall's Transparency Policy, researchers can submit a request by sending a proposal here. All requests will be evaluated independently on a case-by-case basis.
Almirall is committed to perform global clinical trials efficiently in terms of time and quality, relying on internationally-accepted scientific and ethical standards. Clinical trials are carried out according to the local authorities' requirements in the countries where the trials are performed and following European Directives and Guidelines, like Good Clinical Practices of International Conference of Harmonisation, as well as FDA GCP regulations contained in the 21 Code of Federal Regulations, or other international requirements.
The information on this web does not replace advice from health professionals. Patients should always seek medical advice before starting or changing their treatment. Health professionals should consult the approved labelling for the patient's country to ensure that they get the most up-to-date and appropriate information according to local requirements.