How to get access to anonymised patient-level data

We are ready to make data from clinical trials sponsored by LEO Pharma available for scientific purposes. Research proposals from scientists are welcome and will be reviewed by the external board Patient and Scientific Review Board to evaluate the scientific rationale behind the request.

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

clinical trials

Five step process

The process of requesting access to patient-level data consists of five steps:
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.

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).

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.

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.

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.

Patient and Safety Review Board

Granting access to data from clinical trials sponsored by LEO Pharma shall be made for scientific purposes.