About our clinical trials

Transparency in our clinical trials

In Almirall we believe that the publication of clinical trial results should reflect our global transparency policy. In our opinion, public health can be improved by providing easily accessible clinical trials information to doctors and patients.

This transparency initiative follows the joint position on the disclosure of Clinical Trials Information via Clinical Trials Registries and Databases updated on 10 November 2009 made by pharmaceutical organisations such as IFPMA (International Federation of Pharmaceutical Manufacturers & Associations), EFPIA (European Federation of Pharmaceutical Industries and Associations), JPMA (Juvenile Products Manufacturers Association) and PhrRMA (Pharmaceutical Research and Manufactures of America) which supersedes the November 18, 2008, the January 6, 2005 and the September 5, 2005 Joint Positions.

The information published in this web does not intend to 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 updated and adequate information according to their local requirements. Any information published in this web cannot be interpreted as prescribing advice.

This web will publish basic information on the registration and results of Almirall clinical trials:

Clinical Trials Registry: offers information on current, all confirmatory and exploratory efficacy clinical trials. The data will be duly updated on the web site, at the latest , 21 days after the start of patient recruitment of a clinical trial. This information is also posted in www.clinicaltrials.gov.
Clinical Trials Results presents a summary of the trials sponsored by Almirall, carried out with our products approved for marketing and available in at least one country. The results will be published within the year after the end of the trial. These schedules would be subject to adjustment to comply with national laws or regulation or to avoid compromising publication in a peer-review medical journal.

The above two sections contain scientific information on clinical trials without any commercial interest and present the results in an independent manner, regardless of whether or not the results are favourable.

Contact:

I+D (R&D) Almirall
Laurea Miró, 408-410
08980 Sant Feliu de Llobregat
Barcelona-Spain

Ethics and rigor in clinical assessment

Strong product pipeline

See pipeline

Almirall carries out its clinical trials according to local regulations in the countries where the trials are performed and following international declarations and guidelines, Declaration of Helsinki and Good Clinical Practices.

The Declaration of Helsinki objective is to guarantee the rights of the clinical trial participants.

Good Clinical Practice (GCPs) is an international ethical and scientific quality standard to ensure the safety and well being of the clinical trial participants and the quality of the results.

The GCP guideline was issued by the International Conference on Harmonisation (ICH), with Health Authority representatives from Europe, the US and Japan and the pharmaceutical industry.

Almirall performs global and complex clinical trials efficiently in terms of time and quality, relying on our scientific and ethical standards and a profound knowledge in the clinical development of new pharmaceutical products.

See clinical trials