In response to requests for clinical trial patient-level data with scientific merit and intent, Boston Scientific may share validated, anonymized patient-level data from registered clinical trials with qualified healthcare practitioners or academic researchers in response to a formal clinical research proposal, and when the request is in the same therapeutic area as the original study, and when the scientific intent of the request is clear.
Clinical trial data may be shared when not in conflict with all other applicable regulations, laws, or Boston Scientific policies and/or written agreements. Data may be provided for regulated and approved product 6 months following manuscript publication and after the posting of the study results on clinicaltrials.gov. If made available, data will be accessible for at least five years. There will be limited data availability for trials prior to January 1, 2018. Boston Scientific will disposition requests consistent with these and other internal company criteria for data sharing.
For questions related to Boston Scientific Data Sharing Requests contact ClinicalSolutions@bsci.com