Moderna is committed to enhancing diversity in clinical trial participation. The goals are to enhance education about the role of clinical trials, increase awareness of clinical trials, expand diversity in clinical trials by reducing barriers to clinical trial access and participation, use real world data to enhance information on diverse populations, and increase information about diversity and inclusion in clinical trials. The commitment also includes how clinical trials are conducted to protect the rights, safety, and well-being of clinical trial participants. Today, research participants’ rights are protected by law and by ethics committees such as institutional review boards, or IRBs.
At the core of these principles Moderna is striving to better serve historically underserved populations. By diversifying clinical trial populations, we can better reflect the broad patient population that will use the new medicine once it is approved and improve health outcomes. It is with these core principles in mind that the Moderna commits to continuing to work with community groups, patients, patient advocacy groups, regulatory authorities, health care practitioners, academics, and policymakers to define the systematic and impactful approaches that can enhance the diversity of clinical trial participants and help reduce health care disparities.
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, preserve regulatory authority, and cultivates/encourages new research.
Moderna Clinical Trial Disclosure
and Transparency Policy
At such time when requests for “compassionate use” or equivalent uses of an unapproved drug product arise or may potentially arise, Moderna will make its policy on compassionate use publicly and readily available, in accordance with FDA regulations and equivalent international regulations.
Plain Language Summary (PLS)
These summaries (also called layperson summaries, plain language summaries, lay language summaries, simple summaries, and trial results summaries) are intended to make the clinical results of these studies understandable and accessible to patients, caregivers, and a general audience.