Clinical data sharing
Clinical Data Sharing
Blueprint Medicines is committed to making clinical trial data available to the research community in order to
build scientific knowledge and understanding, advance medicine and treatment, and improve public health.
Clinical Trial Disclosure
Blueprint Medicines lists all interventional trials conducted by the company (Phase 1-4) and submitted for authorization to European Union or United States regulatory authorities on www.clinicaltrialregister.eu or www.clinicaltrials.gov. Additionally, we make summaries of all clinical-trial study reports publicly available through those registries after product approval and formal publication of the results to the extent this is consistent with patient privacy, the company’s publication rights and the safeguard of confidential information.
TO REQUEST
DATA
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Data Privacy
Blueprint Medicines recognizes and is committed to protecting the privacy of personal data related to all individuals with whom we interact including our employees, patients,
vendors, and healthcare providers.
Any data we share with third-party researchers is anonymized in accordance with applicable standards.
We do not share data when we believe that there is a reasonable likelihood that individual data can be de-anonymized or data subjects re-identified.
Clinical Data Sharing with Researchers
Blueprint Medicines will consider requests from qualified researchers for data and study reports of completed and published Blueprint Medicines sponsored Phase 2 – 4 clinical trials relating to Blueprint products and indications approved in the United States and the European Union.
Blueprint Medicines will not consider requests for data or reports from clinical trials that are not yet completed or have not been published. Additionally, we are unable to consider requests for data or reports derived from externally sponsored studies (e.g., without limitation, investigator-initiated studies).
When submitting your request, please ensure you include a current CV (not older than 1 year) of all primary members of the research team and a summarized research plan that includes the following (each section should be no more than 1-2 paragraphs):
- Background/Rationale
- Overview/Hypothesis with Primary and Secondary Objectives
- Primary & Secondary Research Endpoints
- High-level Statistical Analysis Plan
- Any coordinating research institutions and/or funders
Each request will be reviewed and evaluated by Blueprint Medicines based on (not an exhaustive list):
- The data requested
- The rationale for the proposed research
- The qualifications and experience of the researcher(s)
- Any potential conflicts of interest
- Source(s) of research funding
If Blueprint approves your research project, Blueprint will share the relevant data with you on the condition that you agree under a data sharing agreement:
- Not to share these data with any unauthorized third party,
- Not to identify (or attempt to identify) study subjects related to these data,
- To use the data only for the purpose of the research project identified in the agreement, and
- To publish the results of the research project conducted with these data in a reputed peer-reviewed scientific journal or at a scientific congress
- To agree to other relevant terms including, for example, those concerning intellectual property, duration of usage, and conflicts of interest.