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.
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.
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.
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.
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.