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Alnylam

About Alnylam is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment options. RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of debilitating diseases with high unmet medical need.

We are committed to our mission to impact patient lives and, as the leader in RNAi therapeutics, we fundamentally believe it is our responsibility to advance science and to share what we have learned.

Alnylam is proud to join the Vivli consortium in support of our transparency initiatives.
How we share on the Vivli Platform Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data Request Form to request Alnylam’s data package(s).
Studies Listed for Sharing We will consider data requests from qualified researchers for anonymized, patient-level and study-level clinical trial data from Alnylam sponsored trials that meet the following criteria:

  • Global Phase II-IV interventional clinical studies
  • Completed on or after 01 Jan 2013
  • Not part of an ongoing or planned regulatory submission
  • Product has received marketing approval in:
    • US and EU
    • US or EU (when regulatory submissions in both regions are not planned).
    • Other country (when US or EU regulatory submissions are not planned).

Data will be provided to the researcher pending approval of a research proposal and a Data Use Agreement signed by the lead researcher and institution.
Exceptions There are certain situations where Alnylam may not share data, even if a study meets the above criteria. These include the following:

 

  • There is a reasonable likelihood that the study participant could be identified, such as with trials for rare diseases where the patient population and clinical centers of excellence are limited, and trials with a single site.
  • The data cannot be readily anonymized without compromising the privacy of trial participants.
  • Data sharing is prohibited by the informed consent; or where regulatory, legal, contractual, or other limitations exist.
  • It is necessary to restrict information to protect commercially confidential information or intellectual property rights.
  • There is a conflict of interest.
  • There are practical constraints that limit our ability to provide the data (for example, issues related to the format of the databases, documentation is not in English)
  • A data request proposal competes with, and/or conflicts with, our publication plan for the research.
  • A trial has been discontinued prematurely and there is insufficient enrollment to warrant analysis.
When Studies are Listed Studies are listed 12 months after the study product and indication have been approved by regulatory authorities as described above, and after the primary manuscript describing the results have been accepted for publication, whichever is later.
Additional Conditions for Access Data requests must be from qualified researchers with the appropriate competencies to perform the proposed analyses. Research teams must include a biostatistician.
What information will be provided Based upon the specific request, the following information may be provided where available:

🗹 De-identified Individual Patient Data (IPD) – data collected for each patient in the clinical trial.

🗹 De-identified study-level data – the dataset used for the study data analysis.

🗹 Protocol – describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial, as well as information about amendments.

🗹 Statistical analysis plan – describes statistical analysis plans that include methods of analysis, procedures for data handling, and data displays (figures and tables) that were used for the trial.

🗹 Redacted clinical study reports – the report of efficacy and safety data from the trial.

🗹 Annotated Case Report Form – a blank case report form with descriptions of the data collected and how they are described in the dataset.

All documents will be redacted/anonymized to protect personal data of study participants, study personnel, and Alnylam employees, as well as to protect any company confidential information or Intellectual Property.
Questions or enquiries To enquire about patient-level data for trials not listed, or to submit questions related to Alnylam data sharing, please contact support@vivli.org.
Review Criteria for Data Requests Alnylam will evaluate data sharing requests based on the following:

 

  • Data requested
  • Hypothesis to be tested and the rationale for the proposed research
  • Qualifications of the research team
  • Statistical analysis plan
  • Ethical Research Plan
  • Publication plan
  • Certification that the stated research purpose has been declared fully and openly and that the research as described will be conducted and reported in good faith
  • Source of funding
  • Potential conflicts of interest
Data Request Review Process Alnylam reviews all data requests internally based on the criteria set forth above.
Access to study documents without participant-level data Documents that can be requested without participant level data are:

 

  • Statistical Analysis Plan
  • Clinical protocol
  • Clinical study report
Anonymization Standards  
Clinical Study Register or Website For more information on Alnylam clinical trial transparency, visit our policy site at: https://www.alnylam.com/alnylam-rnai-pipeline/clinical-trials/clinical-trial-transparency/
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