How to access clinical trial datasets
Access can be granted to datasets from Novo Nordisk sponsored clinical studies completed after 2001 for product indications approved in both the EU and US, if Novo Nordisk assesses that they can be effectively de-identified to protect patient anonymity. Researchers can complete searches for studies of interest here.
In order to get access to a specific dataset, researchers must submit their research proposal. In doing so the researcher accepts a number of legal provisions, including without limitation:
- No attempt to identify or contact research subjects.
- Use the data only for the purposes described in the research proposal.
- No dissemination or sharing of the data with any third parties not mentioned in the research proposal.
- No use of the data for any commercial purposes.
- Agreement that Novo Nordisk gets a fully paid-up, unrestricted non-exclusive license to any and all inventions that may result from the analysis of Novo Nordisk data.
- Immediate notification to Novo Nordisk and relevant health authorities of any health or safety concerns that may have arisen from the analysis of Novo Nordisk data.
- Declaration of the intent to publish findings of scientific and medical importance in relevant peer-reviewed journals.
Before the request is forwarded to the Independent Review Board, the Secretariat supporting the Independent Review Board checks whether all the mandatory elements of the research proposal have been included. The Secretariat also checks whether the request pertains to data from Novo Nordisk sponsored trials completed after 2001 on Novo Nordisk product indications approved in both the EU and US and whether the data is already listed in the Novo Nordisk data sharing system.
If the requested data is not already listed, the Secretariat will conduct an assessment of the practicalities and timelines for granting the access. More information about this is included in the Independent Review Board Charter.
The Independent Review Board assesses all complete requests and approves or rejects the proposal without any interference from Novo Nordisk. For the details of how the Independent Review Board operates, please see the Independent Review Board Charter.
The Independent Review Board meets every quarter, depending on whether any access requests have been received, to discuss and make decisions on access requests submitted until five weeks before the Independent Review Board meeting. The Independent Review Board communicates its final decisions directly to the requesters and to Novo Nordisk.
In case of approval, Novo Nordisk provides the trial dataset which is de-identified to protect patient anonymity together with the redacted Clinical Study Report, thus enabling the researcher to complete the proposed analysis. The data access is granted within a web-based system that includes a statistical computing environment. Access will be limited to data from the specific trial(s) noted in the request.
The researcher must then complete the study and notify the Independent Review Board Secretariat of any pending publications.
Complete access requests will be listed and their status tracked once the access has been granted.
Please note that your request can only be processed if the mandatory elements of the research proposal have been attached.
Mandatory elements to be included in access requests
- Title of the proposed research
- Scientific rationale and relevance of the proposed research describing the objectives and the hypotheses corresponding to the objectives of the research
- Short lay summary of the proposed research intended for public disclosure
- Research methodology and data (brief description of the intended method for the use of the requested data and a detailed description of the different data sources of the data that is intended to be included)
- Statistical analysis plan (include a description of the endpoints and their time points and the planned statistical analyses including the analysis set, the analysis models (with factors and covariates), any transformation of data, plans for handling of missing data, plans for addressing multiplicity issues and plans for sensitivity analyses)
- Publication plan (list the planned number of abstracts and manuscripts (i.e. ‘working title of these’) and the scientific congresses under consideration for presentation of the research findings. Include the anticipated timelines)
The research team (list the team members with name, post/position and abbreviated CV)
Name the funding source (list grants from governments, agencies, donations, funding from employers, consultancies, honoraria and commercial funding from for profit organisations or other payments that will be used for the research)
For each member of the research team please provide:
- Financial relationships that could be perceived to influence the planning, conduct or interpretation of the research:
- Board membership
- Non-financial real or potential conflict of interest that could be perceived to influence the planning, conduct or interpretation of the proposed research. For example potential biases based on pre-existing personal views, academic or commercial competition, personal relationships or institutional affiliation
A signed copy of the Data Sharing Agreement (DSA) should be included. The Data Sharing Agreement is to be sent:
- as a scanned copy in the access request email
- as a hard copy with the original signatures to the lRB Secretariat at the following address:
Novo Nordisk A/S
Att: IRB Secretariat, Clinical Transparency and Medical Writing Office
Vandtårnsvej 114, DK-2860 Søborg, Denmark, [email protected]
(Note: If you wish to receive a hard copy of the countersigned DSA for your own records, please submit two signed originals.)