ALNYLAM POLICY ON CLINICAL TRIAL TRANSPARENCY

Our Commitment

At Alnylam, transformational, world-leading science 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 patients and physicians, and engender greater public confidence in the safety of investigational and newly 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
  • Protects 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.

Transparency Activities at Alnylam

Clinical Trial Registration

Alnylam registers clinical trial information for Alnylam-sponsored Phase I-IV clinical studies on Clinicaltrials.gov, EudraCT, and other registry websites in compliance with applicable global, regional, and local regulations and industry association principles. In addition, we voluntarily register and provide study information on healthy volunteer studies, observational trials, and expanded access programs on Clinicaltrials.gov.

Results Summaries to Clinical Trial Registries

The posting of summary results of Alnylam-completed trials to clinical trial registries is a fundamental element of our policy on clinical trial transparency. Summary results for all Alnylam interventional clinical trials, in accordance with applicable transparency laws and regulations, are made available on publicly accessible clinical trial registries such as Clinicaltrials.gov and the European Union Clinical Trials Register, as well as local country registries where required (e.g., Spain REEC, Japan JAPIC). These results are reported regardless of the outcome of the trial.

Plain Language Summaries of Results and Return of Results to Patients

As an extension of our efforts to educate and support patient communities, and to uphold our commitment to association principles, Alnylam is committed to providing trial summaries in an easy-to-understand format (referred to as plain language or lay language) to our trial participants.

Publication in Peer-Reviewed Venues

Alnylam submits manuscripts for publication in peer-reviewed scientific and medical journals, which are subject to the peer-review process at the discretion of the journal editors. Alnylam will continue to ensure that summaries of clinical trial results of significant importance are submitted for consideration as abstracts during congresses and/or for publication in peer-reviewed journals, regardless if the results of the study are positive or negative. This includes results from studies with investigational medicines whose development programs were discontinued.

Data Sharing with Researchers

Alnylam is working to adopt mechanisms for sharing de-identified patient-level datasets with qualified scientific and medical researchers. We are committed to developing a process that will enable us to receive, review, and fulfill requests for access to datasets for research proposals that demonstrate scientific merit and a purpose that promotes biomedical innovation. We will provide more information on our efforts around these activities as they evolve.

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