Step 1: Feasibility assessment by LEO Pharma
LEO Pharma initially assesses whether anonymised patient-level data can be shared from the requested trials, given the conditions of the informed consent agreement with the patients at the time the trial was initiated. Informed consent agreements have differed over time, and in respect of the boundaries of these agreements, a feasibility check must be performed.
To ensure transparency the Patient and Scientific Review Board will receive all Data Availability Forms. In cases where LEO Pharma has assessed that the requested data cannot be delivered within the boundaries of patients’ informed consent or cannot be sufficiently anonymised, the Board will also receive a copy of the informed consent form of the respective trials in an anonymised format, together with a clarification of the assessment made by LEO Pharma.
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.