BioNTech honors the privacy of the participants in its clinical trials by safeguarding personal data with the appropriate security measures in accordance with the applicable data protection requirements. As with medical records, all information collected during clinical trials will be kept confidential. Information regarding a trial participant’s identity will not be transferred to BioNTech and will not be included in any reports or publications.
Trial participants will be informed in a timely manner if new information becomes available that may impact their well-being and/or their willingness to participate in the trial.
At BioNTech, we want to improve the quality of care for people. In accordance with this mission, we ensure that all trials and clinical research activities meet or exceed international ethical and human rights principles to respect and protect the rights, well-being, safety, and dignity of all participants in our clinical trials.
All BioNTech clinical trials are conducted in accordance with the clinical trial protocol, the ethical principles that have their origin in the Declaration of Helsinki (2000), Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) guidelines, and applicable laws and regulations.
By complying with the above guidelines, we ensure the highest standards when designing trials, as well when conducting, performing, monitoring, auditing, recording, analyzing, and reporting information pertaining to a clinical trial. These guidelines ensure that the data and reported results are accurate and credible. Importantly, they also protect the rights, well-being, and confidentiality of any data of the trial participants.
Our external partners
To support clinical trials, BioNTech works with Contract Research Organizations (CROs) and other qualified independent service providers. They are supervised by BioNTech employees and we regularly audit these external organizations to ensure that all regulatory requirements are met and that they share our ethical standards. We also maintain partnerships with other pharmaceutical companies with whom we co-develop investigational medicines.
To ensure compliance with the highest ethical standards and to protect the rights, safety and well-being of trial participants, clinical trials are reviewed by independent panels known as Institutional Review Boards (IRBs) in the US and Independent Ethics Committees (IECs) in other parts of the world. IRBs/IECs also review the appropriateness of the clinical trial protocol as well as the risks and benefits to trial participants. IRBs/IECs are independent panels composed of researchers, ethicists, legal experts, community members and physicians that are not directly involved in the trial.
In addition, clinical trials are reviewed and overseen by non-independent safety review committees (SRCs) and independent data and safety monitoring boards (DSMBs). This allows for further protect the rights, safety and well-being of the trial participants while studying the safety and effectiveness of our investigational products.
Our transparency declaration
Sharing health information is fundamental for the good functioning of healthcare services, for patients’ safety, and for advancing research and improving 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”. External researchers wishing access to this health information for in-scope clinical trials should submit requests to [email protected]. 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 (at the time of study start) 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:
- Where the first trial participant has given informed consent on or after 25 March 2022.
- Where BioNTech is not prohibited from disclosing health information, for example by contractual agreements with development partners.
Our commitments:
- Irrespective of where the trial is performed, to register all studies on the website clinicaltrials.gov before the first trial participant has given informed consent.
- Irrespective of where the trial is performed, to publicly post results for all primary and secondary outcome measures, irrespective of outcome, on the website clinicaltrials.gov within 12 months of trial completion (i.e., last participant last visit [LPLV]).
- To publicly post an ICH E3-based clinical trial report synopsis, irrespective of outcome, on the BioNTech Clinical Trials website (https://clinicaltrials.biontech.com/) within 12 months of LPLV. Any personal data or commercially confidential information in these synopses will be redacted.
- To post lay summaries of key results on the BioNTech Clinical Trials website within 12 months of LPLV.
- For Phase 2 to 4 clinical studies, to submit results 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 trial 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:
- All personal data and commercially confidential information in shared clinical trial reports will be redacted.
- This sharing will be no earlier than 12 months after LPLV.
- To share upon request anonymized data from interventional clinical studies conducted by BioNTech with the COVID-19 vaccine COMIRNATY® (and variant vaccines) that were submitted to health authorities in support of applications for marketing authorization in the European Union and/or United States.
- Requests from appropriately qualified researchers must be submitted to the relevant data sharing platform for assessment.
- Data will be available beginning 24 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.
Our publication policy
Irrespective of the 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 the BioNTech Transparency Declaration). When preparing publications, BioNTech complies with good publication 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 and potential advancements in the field. 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:
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- 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 Editors (ICMJE)
Compassionate use
We recognize that patients, caregivers, and healthcare providers may wish to access our investigational medicines outside our clinical trials. Different pathways are present worldwide to regulate such situations that may be referred to as “expanded access”, “compassionate use”, “managed access”, but may be known by other names depending on local regulations and type of program.
Currently, we do not consider inquiries for compassionate use of our investigational medicines. We at BioNTech reinforce awareness of and participation in clinical trials that offer the most appropriate level of monitoring and oversight for novel investigational medicines.
Clinical trials are strictly governed and monitored research studies that ensure that investigational medicines are administered in a controlled environment that protects the rights and well-being of the trial participants. The goal of clinical trials is to demonstrate clinical benefit and safety for patients which can ultimately lead to the approval of new medicines and have the potential to support the patient population more broadly.
A list of our clinical trials is available in the search bar below or on clinicaltrials.gov. Please contact [email protected] for additional inquiries or questions about our clinical trials.