We at Moderna, build on trust, integrity, and transparency. That’s why we choose to share our policies and clinical trial data with researchers, patients, volunteers, and the public. Every Moderna clinical trial is conducted in alignment with global requirements according to the highest industry standards, as well as scientific, ethnical, clinical, and internal company policies.
Accessible and Transparent Clinical Trial Data Empowers and Ensures Trust
Moderna recognizes that it is important for regulators, researchers, trial participants, and other concerned parties to have access to clinical trial information to advance medical understanding and progress. Knowledge enlightens and empowers stakeholders to help make sound medical decisions. It is also important that this access works in ways that protect patient privacy, comply with global laws, regulations, standards and enable new research.
Moderna Clinical Trial Disclosure
and Transparency Policy
Registering clinical trials when they begin, providing timely updates, submitting summary results, and making information publicly available are all critical to ensuring transparency. Moderna’s Transparency & Disclosure Policy describes the data sharing activities of Moderna-sponsored clinical trials.
For patients who do not qualify for clinical trials, Moderna may open an expanded access program for a medication prior to its approval. Currently, we do not have expanded access programs open for our investigational product. We continually re-evaluate the provision of expanded access programs when new safety and efficacy information becomes available for each medication as we complete definitive Phase 3 studies that allow the benefit and risk to be fully assessed.
Please check back for updates on availability of expanded access or contact [email protected] with any questions about our medications.
Considerations for Participation in Expanded Access Programs (EAP)s:
Moderna adheres to the following guidelines when considering providing patients with access to unapproved investigational drugs outside of a clinical trial:
The patient has a life-threatening illness severe enough to potentially require hospitalization. For Expanded Access to be appropriate, the patient should exhaust all available therapeutic options typically used to treat the disease or no longer be able to tolerate these treatments.
A patient seeking expanded access to an unapproved investigational product should not be eligible for participation in an actively enrolling clinical trial, with some exceptions. Geographic limitations alone would generally not be considered a barrier to participation in clinical trials.
The potential benefit to the patient seeking Expanded Access should outweigh the combined potential risks of the investigational drug and the outcome of the disease itself. To support the use of the investigational drug in medical treatment of the patient, there should be early data available, including dosing information, to determine that the benefit-risk balance is positive for the specific indication for which the request is made.
The completion of the clinical trial process is necessary to demonstrate that an investigational drug is safe and effective for its proposed indication. This is required to obtain regulatory approval by national health authorities and to make the new medicine available. Thus, granting access to an investigational drug through an expanded access program should not delay, interfere, or compromise the completion of clinical trials that are intended to support approval by national regulatory authorities.
The development of medicines for serious or life-threatening diseases represents an urgent and unique challenge that requires special attention. Moderna is committed to continuing its work with patients, patient advocacy groups, regulatory authorities, healthcare practitioners, academia, and policymakers to help accelerate the development and availability of innovative new medicines for patients.
We continually re-evaluate the provision of expanded access programs.
Clinical trial data transparency has multiple elements, all of which are aimed at improving access to clinical trial information in order to inform medical decision-making, advance scientific discovery and accelerate development of new treatments to benefit patients.
Conducting Clinical Trials
Prior to initiating a clinical trial in the U.S., Moderna must submit the required Investigational New Drug (IND) application to the Food and Drug Administration (FDA), detailing the pharmaceutical product that Moderna plans to study, as well as the trial design, protocols, and other relevant details, unless the trial is exempt from requiring an IND.
For clinical trials in countries other than the U.S., Moderna must apply and obtain approval from the relevant health authority as required by local laws, regulations, and guidelines.
A qualified Institutional Review Board (IRB) or Ethics Committee (EC) must review and approve all Moderna trials prior to initiation. IRBs/ECs enlisted to review Moderna protocols must be independent from Moderna and must have members with appropriate medical and scientific qualifications. Potential participants may not be enrolled in a Moderna clinical trial until the IRB or EC provides written authorization for the trial to begin.
Clinical trial protocols must define medically sound eligibility criteria and ensure that the trial population is scientifically appropriate. All trial participants must meet all eligibility criteria, and all trial-specific procedures and assessments must be performed as described in the protocols.
Clinical trial participants may only be enrolled after providing their voluntary informed consent or informed assent, as applicable, in compliance with local laws and regulations. The risks associated with participation in the trial must be shared, and potential participants (or their legally authorized representatives) must be offered the opportunity to discuss those risks and other treatment options with the investigator and/or qualified trial staff.
For participants who are incapable of giving informed consent (e.g., pediatric participants or participants with mental disabilities) or where required by local laws, the permission of a legally authorized representative (LAR) is required.
Moderna respects the privacy rights of its clinical trial participants and safeguards the confidentiality of their medical information in accordance with all applicable laws and regulations. In the U.S., any access by Moderna, regulatory authorities, or other researchers to patient information must be granted in compliance with the Health Insurance Portability and Accountability Act (HIPAA).
Moderna may provide compensation for participants to participate in a clinical trial, provided that the compensation are non-coercive. Any proposed trial participant payment must be reviewed and approved by an independent IRB or EC.
It is Moderna’s duty to design, conduct, and monitor all Moderna clinical research to ensure that the rights and safety of participants are protected. Investigators and clinical trial staff must be trained on the clinical trial protocols, the pharmaceutical product(s), and procedures needed to conduct the trial. Any suspected deviations from Moderna’s clinical trial protocols must be promptly investigated, and appropriate corrective action must be taken.
Appropriately trained and qualified individuals must monitor Moderna clinical trials and verify compliance with International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) , adherence to protocols, enrollment of appropriate trial participants, and the accuracy and complete reporting of clinical trial data. If Moderna learns of deficiencies on the part of a clinical investigator, Moderna must work with the investigator to ensure compliance or discontinue the investigator’s involvement in the trial and report the issue to the relevant authorities.
The role of DSMB is to ensure and monitor 1) blinded and randomized clinical trials with mortality or major morbidity as primary or secondary endpoints, 2) trials where participants may face an elevated safety risk, and 3) other clinical trials where an independent review of trial data is warranted. Establishment and conduct of the DSMB will follow federal and local requirements, as well as Moderna policies.
Before beginning a clinical trial, Moderna must determine the appropriateness, relevance, and feasibility of continuing to supply the investigational treatment, alternative therapies, and/or necessary follow-up care to trial participants after the conclusion of the clinical trial. Post-clinical trial care must then be provided after the trial is complete as required by local regulations.