Step 4: Preparation and provision of anonymised patient-level datasets
Following approval, LEO Pharma is responsible for preparing and providing the anonymised patient-level data. The following data can be released after approval of request:
• Anonymised raw data in the format they have been analysed by LEO Pharma and submitted to authorities
• Anonymised analysis data sets required to conduct the requesting researchers’ approved analysis plan
• Supporting documentation assisting the research group in understanding and interpreting the results of the analysis contained in the clinical study report, including:
- Clinical study protocol
- Clinical study report
- LEO Pharma statistical analysis plan update, if available
- Annotated Case Report Form for the raw data
- Dataset specifications, if available.
As a prerequisite for getting access to data, the researcher must sign a Data Sharing Agreement with LEO Pharma. The Data Sharing Agreement covers the following terms:
• Data must only be used for the agreed purpose. In this respect, the researcher must also agree that that the analyses/research conducted will not at any point be used for commercial purposes.
• Acceptance to safeguard personal data and not to establish the identities of clinical trial participants.
• LEO Pharma must be informed immediately, and no later than within twenty-four (24) hours, of any potential safety concerns.
• The research/analyses must be completed within 24 months of access to data.
• The results of the analysis must be shared with LEO Pharma.
• Publication of the results in a peer-reviewed journal must be pursued or otherwise make the results publically available.
• Provide LEO Pharma with a copy of the manuscript at the time of journal submission.
• Disclose any potential conflicts of interest.
The Data Sharing Agreement template is provided here. Note that there may be minor modifications to the actual agreement.
It is estimated that it will take up to 30 working days to provide anonymised patient-level data after signing of the data sharing agreement.
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.