How to get access to anonymised patient-level data

Granting access to data from clinical trials sponsored by LEO Pharma shall be made for scientific purposes. This is why the main task of the Patient and Scientific Review Board is to evaluate requests for data based on the scientific rationale behind the request.

This website contains  information about how to get access to anonymised patient level data from LEO Pharma sponsored clinical trials.  

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. 

How to get access to anonymised patient-level data

This process 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

For further details, see the Patient and Scientific Review Charter, and the data request forms to be used: Data Feasibility Form and Request for Access to Data.

Step 1: Feasibility assessment by LEO Pharma

A completed Data Feasibility Form must be sent to the clinical trial disclosure mailbox in which the researcher specifies the trial(s) of interest.

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.

Step 2: Research proposal

A research proposal (using the Request for Access to Data template) can be submitted only after a positive feasibility assessment by LEO Pharma (Step 1). The research proposal shall specify:

• Scientific objective
• Benefits of the patients
• Publication plan
• Qualifications of the researchers
• Conflicts of interest
• Patient confidentiality
• Safety
• References

The research proposal will be forwarded to the Patient and Scientific Review Board for review and decision. A secretariat of LEO Pharma will screen the research proposals to ensure that they are complete in the sense that all necessary items are included.

Complete research proposals should be submitted at least 30 working days prior to the next Board meeting in order to be considered at that meeting.

Step 3: Review and decision by the Patient and Scientific Board

Granting access to data from clinical trials sponsored by LEO Pharma shall be made for scientific purposes. The review process of the Patient and Scientific Review Board is necessary to determine that the research proposal has a valid scientific rationale, is non-commercial, and is in the best interest of patients.
The Patient and Scientific Review Board will make one of three decisions:

1. Approval to provide access
2. Rejection of the research proposal
3. Re-submission possible.

The Patient and Scientific Review Board makes its decisions independently from LEO Pharma.

Currently, four Board meetings are scheduled per year.

Step 4:  Preparation and provision of anonymised patient-level datasets

The decision of the Patient and Scientific Review Board will be communicated by the secretariat of LEO Pharma to the researcher within 15 working days of the Board meeting.

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.

Step 5: Analysis of the data

LEO Pharma provides controlled access to the anonymised data. This implies that the analyses by the researchers shall be performed in a closed environment with the required analysis tools and computer programs available. No download or printing of data is allowed. When the researchers have completed their analyses, the final output is exported from the system by LEO Pharma.

The analyses of data must be conducted according to what was approved by the Patient and Scientific Review Board. The conditions of the Data Sharing Agreement must be observed (see Step 4).

For data access support, contact the clinical trial disclosure mailbox



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