Reporting of clinical trial results
LEO Pharma considers it an ethical and scientific responsibility to report the results of our clinical trials. By ensuring that all our clinical trial results are accessible, we minimise the risk for biased and selective reporting.
A key part of our efforts to increase clinical trial transparency is the guarantee that people taking part in our trials can access the trial results. The people taking part in our trials are informed about when and where the trial results will become available, and they receive a thank-you note for their valuable contribution.
Public data registries
LEO Pharma's clinical trial results are reported according to applicable laws and regulations and international recommendations on:
• various national registries.
Results are reported after a clinical trial has been completed or stopped, regardless of the outcome, according to set timelines by the governing authority.
Starting September 2019*, we publish the results of all trials with products that are approved anywhere in the world on the global public registry clinicaltrials.gov.
*Refers to the year of the clinical trial protocol.
Important information regarding LEO Pharma Clinical Trial Disclosure
Access to the site requires that you acknowledge and accept the following:
- The information on this website is provided solely to increase transparency of LEO Pharma clinical trials. It is not intended to promote any prescription, sale, or use, whether approved or off-label, of any medicinal product from LEO Pharma or from any other company.
- The documents on this site have been prepared in accordance with applicable ICH guidelines upon completion of the respective clinical trials. Except edits necessary for the protection of commercially confidential information and those for the protection of personal data, the documents are in the same format as they were originally prepared for approvals from the regulatory authorities.
- The documents provided on this site contain data and results regarding approved and non-approved uses, formulations or treatment regimens. As data and results from clinical trials are of a scientific nature, you cannot rely on this information as a recommendation or advice regarding the use/non-use of any products or treatment options.
- The information is not intended to replace the advice of a healthcare professional. As a patient, you must always consult your doctor for further information and instructions.
- The information is not intended to be used by physicians for making prescribing decisions. If you are a physician, you should always refer to the specific authority-approved labelling information approved for the product in the country or region of the patient.