How to get access to anonymised patient-level data
The approval of a researcher's request for access to data shall under no circumstances be considered or interpreted as a recommendation or appraisal of the research proposal, either by the Patient and Scientific Review Board or by LEO Pharma. The same position applies for the research outcome.
The process of requesting access to patient-level data consists of five steps:
Step 1: Feasibility assessment by LEO Pharma
Step 2: Research proposal
Step 3: Review and decision by the Patient and Scientific Review Board
Step 4: Preparation and provision of anonymised patient-level datasets
Step 5: Analysis of the data
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.