BioNTech Transparency Declaration
Sharing health information is fundamental for the good functioning of healthcare services, for patients’ safety, and to advance research and improve public health. BioNTech is committed to disclosing information about clinical data and clinical trials, in line with all applicable laws and regulations, including data privacy laws. In addition, BioNTech has committed to sharing additional health information in its “BioNTech Transparency Declaration” issued on 25 March 2022. External researchers wishing access to this health information for in-scope clinical trials should submit requests to firstname.lastname@example.org. A report of compliance with this declaration can be found here.
The sharing of health information is fundamental for the good functioning of healthcare services, for patients’ safety, and to advance research and improve public health.
BioNTech is committed to disclosing health information, in line with all applicable laws and regulations, including data privacy laws.
In addition, BioNTech commits to the below items for all interventional clinical studies (Phase I and beyond) sponsored by BioNTech that are investigating authorized treatments, non-authorized use of authorized treatments, and investigational treatments (i.e., non-authorized treatments).
This commitment only applies for clinical studies:
- With first study participant in (FPI) after the date of issue of this declaration (25 March 2022).
- Where BioNTech is not prohibited from disclosing the health information, for example by contractual agreements with development partners.
- Irrespective of where the study is performed, to register all studies on the website clinicaltrials.gov before enrollment of the first study participant (i.e., FPI).
- Irrespective of where the study is performed, to publicly post the outcomes for all primary and secondary outcome measures, irrespective of outcome, on the website clinicaltrials.gov within 12 months of study completion (i.e., last participant last visit, “LPLV”).
- To publicly post expert summaries of the outcomes for all primary and secondary outcome measures, irrespective of outcome, on a publicly-accessible website within 12 months of LPLV. Any personal data or commercially confidential information in these summaries will be redacted.
- To post lay summaries of key results on a publicly-accessible website within 12 months of LPLV.
- To submit the outcomes for all primary and secondary outcome measures, irrespective of outcome, for publication in academic journals within 30 months of LPLV.
- To share upon request clinical study reports (ICH E3) that were submitted to health authorities in support of granted applications for marketing authorization in the European Union and/or United States:
- This sharing will be subject to contractual control to highlight that no personal data will be shared and to prevent commercial use of the shared information
- All personal data and commercially confidential information in shared clinical study reports will be redacted.
- This sharing will be no earlier than 12 months after LPLV.
- To publicly post reports of compliance with this declaration once per year (these reports will summarize the number of requests for sharing, the outcomes of the requests, and the outcomes of any audits performed on compliance with this declaration).
ICH E3: ICH E3 Structure and content of clinical study reports, see here.
Compliance with this declaration
The requirements of this declaration are set out in written standard operating procedures. Compliance with these requirements will be subject to regular audits.
BioNTech Publication Policy
Irrespective of outcome, BioNTech submits the outcomes for all primary and secondary outcome measures in clinical trials for publication in freely accessible and reputable academic journals (for details see BioNTech Transparency Declaration). When preparing publications, BioNTech complies with good publications practices including those established by the International Committee of Medical Journal Editors (ICMJE). Authorship will be determined by mutual agreement and aligned to ICMJE authorship requirements.
As a science-based company, we recognize the need for BioNTech and its personnel to play an active role in the medical/scientific communities. Publishing our data, our advances, and our technologies, is the best way to initiate discussion and debate, and to raise awareness of our activities. When publishing, BioNTech publications must fulfil the following criteria:
- Be non-promotional in content and tone.
- Be scientifically rigorous, fair, balanced, truthful, non-misleading, and supported by literature and/or data.
- Be complete, e.g., present any limitations of the used data or methodologies.
- Be based on data that is robust and available for inspection upon request.
- Must not encourage the prescription, purchase or referral of a BioNTech product in any way.
- Comply with applicable laws, regulations, and ethical/industry guidance.
- Comply with our BioNTech policy to submit the outcomes for all primary and secondary outcome measures in BioNTech-sponsored interventional studies, irrespective of outcome, for publication in academic journals within 30 months of last participant last visit (see the BioNTech Transparency Declaration).
- Weigh our wish to publish against our obligation to protect data privacy, our need to protect intellectual property, and our contractual rights/obligations.
- Comply with recognized good publication practices, including:
- International Society for Medical Research Publication Professionals (ISMPP) Good Publication Practice guidelines
- Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals from the International Committee of Medical Journal
Frequently used terms in a clinical trial
Every clinical trial follows strictly defined protocols and assesses defined clinical outcomes. Learn more about the terminology here