DATA AVAILABILITY STATEMENT
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ONCOLOGY
Sierra Oncology, a GSK company, commits to share clinical study data with qualified researchers to enable enhancement of public health. As such, Sierra will share anonymized patient‐level data on request or if required by law or regulation. Qualified scientific and medical researchers can request patient‐level data for studies of Sierra pharmaceutical substances listed on ClinicalTrials.gov and approved by health authorities in the United States and the EU. Patient‐level data for studies of newly approved pharmaceutical substances or indications can be requested nine months after US Food and Drug Administration and European Medicines Agency approvals. Such requests are assessed at Sierra's discretion, and the decisions depend on the scientific merit of the proposed request, data availability, and the purpose of the proposal. If Sierra agrees to share clinical data for research purposes, the applicant is required to sign an agreement for data sharing before data release, to ensure that the patient data are de‐identified. In case of any risk of re‐identification on anonymized data despite measures to protect patient confidentiality, the data will not be shared. The patients’ informed consent will always be respected. If the anonymization process provides futile data, Sierra will have the right to refuse the request. Sierra will provide access to patient‐level clinical trial analysis datasets in a secured environment upon execution of the data‐sharing agreement. Sierra will also provide the protocol, statistical analysis plan, and the clinical study report synopsis, if needed. For additional information or requests for access to Sierra clinical trial data for research purposes, please contact us at 