Sharing de-identified clinical research datasets advances broader scientific understanding

In order to facilitate the use of data from our clinical research in further scientific investigations, Novo Nordisk has established a new system for sharing of data with external researchers in response to legitimate scientific requests. Via this system external researchers can submit their requests for access to de-identified datasets from Novo Nordisk sponsored clinical trials. The access request procedure requires among other things the researchers to provide pre-defined research protocols, commit to publish the findings regardless of research outcome, and pledge to respect patient anonymity and the intellectual property rights of Novo Nordisk

The Novo Nordisk Independent Review Board charter, consisting of external experts within relevant therapy areas, clinical research and statistics appointed by Novo Nordisk, reviews the requests on a regular basis and grants access to those that are deemed to be scientifically valid and relevant as well as ethically correct. The Independent Review Board assesses the requests according to a scientifically valid as well as transparent and accountable procedure and takes its decisions independently from Novo Nordisk. For details about the Independent Review Board and the way it works, please see the: Independent Review Board charter.

Upon grant of access to a specific dataset by the Independent Review Board, Novo Nordisk will provide access to the trial dataset in a de-identified format, thus enabling the external research team to complete the proposed analysis. Access requests can be filed for Novo Nordisk sponsored clinical trials completed after 2001 for product indications approved in both the EU and US.

Learn more about the application process for researchers requesting access to de-identified clinical trial datasets on the page: How to access clinical trial datasets.

Independent Review Board

Name Post / Position
Annette K. Ersbøll Professor in register based research, University of Southern Denmark
Martin Schumacher Professor of medical biometry and statistics, University of Freiburg
Simon R. Heller Professor of Clinical Diabetes, University of Sheffield