Data availability
Syndax Pharmaceuticals (Syndax) is committed to providing qualified scientific researchers access to anonymized data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. Syndax is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. Following submission of a request (to datarequest@syndax.com), Syndax will provide an outline of the process and requirements for submitting a data request. Feasible requests will be reviewed by a committee of Syndax subject matter experts to assess the scientific validity of the request and the qualifications of the requestors. In line with data privacy legislation, submitters of approved requests must enter into a standard data-sharing agreement with Syndax before Syndax may grant data access. Data will be made available for request after product approval in the United States and European Union, or after product development is discontinued. There are circumstances that may prevent Syndax from sharing requested data, including country- or region-specific regulations. If Syndax declines the request, it will communicate the decision to the investigator. Access to genetic or exploratory biomarker data requires a detailed statistical analysis plan that is collaboratively developed by the requester and Syndax subject matter experts.