Are clinical trials safe?
Since the trial medicine is a new treatment, there could be side effects that are still unknown. The trial doctor will look closely for any side effects of taking part in a trial and will make sure that medical care is given as needed.
There are strict rules on how to run clinical trials. This protects the rights, safety, privacy, and well-being of the people taking part.
LEO Pharma clinical trials always follow all relevant laws and guidelines. This includes the Declaration of Helsinki, an international agreement for ethical standards for medical research. Clinical trials will only take place after approval by the national regulatory authorities and research ethics committees.
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.