A strong commitment to sharing clinical study results is important for medical progress

 

Novo Nordisk is committed to sharing information about all clinical studies and their results, irrespective if these are positive or negative. This is because important contributions to overall medical progress and general medical understanding are made by enabling access to study information for researchers, participants in studies, and anyone else who may be interested.

 

Information about clinical studies is shared in several ways. At the beginning of a clinical study, information is posted in relevant public registries. When the study has ended, the goal is to publish the key conclusions in scientific journals. The results are communicated further by including them in applicable registries and on this website in the form of summaries in layperson language and clinical study reports. In addition, researchers can request access to detailed clinical study data, which they can explore for their own research purposes. All information communicated and shared on clinical studies is de-identified.

 

See below for more details on how clinical study data are shared.

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Novo Nordisk posts information about all clinical studies in publicly accessible clinical study registries. Registries are an important source of information for researchers, medical doctors, and patients because they inform about ongoing and completed clinical studies. The studies are documented in national registries as required by local laws. However, not all national registries are publicly accessible and therefore, the clinical studies are also registered in the US registry ClinicalTrials.gov, which is open to the public. Novo Nordisk clinical trials results can also be found here. In addition, when clinical studies are carried out with at least one study site in the European Economic Area, clinical trial applications for these clinical studies are submitted to the European Clinical Trials Database (EudraCT). The European Medicines Agency makes information from submissions related to phase 2-4 studies in adults and phase 1-4 studies in children publicly available via the EU Clinical Trials Register (EU CTR). All registrations are completed before the recruitment of study participants starts and within the timeframes and formats that are specified by the individual registries. Non-interventional post-authorisation safety studies are registered in the publicly accessible European Union electronic Register of Post-Authorisation Studies (EU PAS Register). Novo Nordisk strives to provide consistent information across registries. Novo Nordisk also supports the WHO initiative of adding a unique identifier to clinical studies in order to track a specific study across the various registries.

Regardless of clinical study outcomes, Novo Nordisk seeks publication of the key conclusions at scientific conferences and in peer-reviewed medical journals. Conference abstracts and scientific articles are submitted to relevant conferences and journal editors, who then decide whether or not to include the information. The submissions follow the guidelines provided by organizations such as GPP3, ICMJE, COPE, PhRMA, IFPMA, and others. Novo Nordisk strives to submit clinical study results that are of medical or scientific importance to scientific conferences and medical journals no later than 12-18 months after study completion.

The results from Novo Nordisk’s clinical studies are communicated within the proper timeframes, in the formats and in the registries that are specified by current laws and regulations. For example, results from phase 2-4 clinical studies are submitted to the US register ClinicalTrials.gov. The results are then made publicly available in the appropriate format, and within the timelines specified in the Final rule for Section 801 of the FDA Amendments Act (FDAAA) of 2007. Results are also submitted to the European Clinical Trials Database (EudraCT). Twelve months after a study’s completion, the European Medicines Agency publishes the results for phase 2-4 clinical studies in adults in the EU Clinical Trials Register. Results from phase 1-4 clinical studies in children are published 6 months after completion. In accordance with legislation, Novo Nordisk posts the entire study reports from non-interventional post-authorization safety studies in the publicly accessible European Union electronic Register of Post-Authorization Studies (EU PAS Register) within 14 days after the report of the results has been finalized.

The reports from all clinical studies that have been completed by Novo Nordisk after 1 January, 2006 are published here. The reports are posted within 30 days after the investigated medicine or medicine indication has been approved in both the United States and the European Union. The reports for clinical studies that have taken place after the US and EU approvals are published on the website 12 months after the study has been completed.

In some cases, Novo Nordisk may decide to discontinue further investigations of a medicine or a specific medicine indication. If the development for market approval is not taken over by another party, the synopses will be published 12 months after the public announcement of the study’s completion or discontinuation. Those results can be found here.

Synopses for all Novo Nordisk studies are published on this website. For phase 2-4 studies, redacted synopses are posted at the time of submission of the results to ClinicalTrials.gov after completion of the study. For phase 1 studies, redacted synopses are posted within 30 days after the investigated medicine or medicine indication has been approved in both the United States (US) and the European Union (EU). The redacted synopses for clinical studies that have taken place after the US and EU approvals are published on the website 12 months after the study has been completed.

For phase 2-4 studies, the layperson summaries are posted at the time of submission of the results to ClinicalTrials.gov after completion of the study. For phase 1 studies, the layperson summaries are posted within 30 days after the investigated medicine or medicine indication has been approved in both the United States (US) and the European Union (EU). The layperson summaries for clinical studies that have taken place after the US and EU approvals are published on the website 12 months after the study has been completed. Layperson summaries are not posted for non-interventional studies.

Researchers who wish to conduct independent analyses based on Novo Nordisk clinical study data can request access to the detailed datasets from Novo Nordisk-sponsored interventional clinical studies that have been completed after 2001, provided that the explored medicine or medicinal indication has been approved in the US and EU. Novo Nordisk’s Independent Review Board evaluates received research proposals and grants access to scientifically robust requests on a quarterly basis. After approval by the Independent Review Board, the de-identified datasets are made available to the researchers within a closed IT system. More information about how to make a request is available here.

To ensure the trust and safety of participants in clinical studies, Novo Nordisk takes steps to protect participants’ personal data. Clinical study documents, such as clinical study reports, synopses, and protocols posted to public websites, are first ‘redacted’. Redaction is a process that ensures that any personal data and/or company confidential information is removed and that the published document is in compliance with regulatory guidance, data protection laws and company policies.

Key legal references and principles on disclosure of clinical study information include:

  • EU Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
  • EU Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies, 3rd revision
  • EU Regulation (EC) No 1901/2006 of the European Parliament and of The Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/ EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
  • Final rule for Section 801 of the FDA Amendments Act of 2007
  • FDA Modernization Act of 1997 (FDAMA), section 113
  • PhRMA and EFPIA Joint Principles for Responsible Clinical Trial Data Sharing (2014)
  • IFPMA Joint Position on The Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2009)
  • IFPMA Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (2010)
  • WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 7th revision, Oct 2013
  • ICMJE – International Committee of Journal Editors – Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, updated Dec 2019
  • COPE – Committee on Publication Ethics – Codes of Conduct and Best Practice Guidelines [site accessed 02/14/2017]
  • GPP3 – Good Publication Practice Guidelines – Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015 Sep 15; 163(6):461-464. doi: 10.7326/M15-0288