Not all people respond to a medicine in the same way. Diversity of age, sex, race, ethnicity, and other factors in clinical trials is critical in evaluating the effectiveness and safety of potential new treatments for all people who may benefit from them. At Alnylam, we are committed to working toward increased diversity, equity, and inclusion in our clinical trials.

Historically, many minority communities have been underrepresented in or mistreated by clinical research. The impacts of this are many, including ongoing bias in drug development, inequality in how people access health-care and mistrust of the pharmaceutical industry. Combined with other factors, this has resulted in lower life expectancies and poorer quality of life among many minority populations.

We are taking tangible steps in the design and management of our clinical trials to lower barriers to participation and ensure more diverse representation.
These efforts include:

• Engaging minority communities directly to educate about clinical trials, demonstrate transparency, and build trust
• Engaging health care providers that serve underserved communities
• Structuring trial protocols to maximize participation of under represented populations
• Setting appropriate goals for enrollment of diverse populations in our trials
• Working with our partners and experts in the field to identify investigators and sites in communities serving racially and ethnically diverse populations
• Ensuring that clinical trials-related communications and materials are culturally appropriate and accessible

At Alnylam, innovative science focused on helping patients is at the core of who we are, and trust, honesty, and integrity are deeply important to how we operate. As an extension of our company culture, Alnylam believes that timely disclosure of clinical study information is important to help advance medical research, inform participants and physicians, and engender greater public confidence in the safety of investigational and approved medicines.

Alnylam is committed to complying with applicable national and international laws, regulations, and principles for clinical trial disclosure and transparency, including those put forth by industry associations and supported by independent research organizations and editors of leading peer-reviewed journals. Alnylam believes that sharing of clinical trial information should be done in a manner that:

• Ensures patient confidentiality and privacy
• Complies with informed consent given by trial participants
• Respects the integrity of national regulatory systems in making benefit-risk decisions in access to products
• Preserves the integrity of our research, our commercially confidential information, and our intellectual property
• Encourages continued investment in biomedical research that advances public health

The below outlines Alnylam’s policy on Clinical Trial Transparency and the framework we follow in sharing clinical trial information with trial participants, family members and other caregivers, physicians, regulators, and independent researchers. We will continue to review and update this policy where appropriate as transparency regulations change and needs for open data sharing evolve.