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 and the European PAS website.
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
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, regulatory agencies, and the general public.
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’s commitment to transparency includes establishing a mechanism for sharing de-identified patient-level datasets with qualified scientific and medical researchers. Alnylam has joined the Vivli consortium, an independent, nonprofit organization that has developed a global data-sharing and analytics platform. Qualified researchers can make requests for anonymized clinical trial data from in-scope studies on approved products through Vivli.org. For more information on our data-sharing scope and policy, visit the Vivli website, or contact us at email@example.com.