Clinical Data Sharing
Our Commitment to Sharing Data:
Agios is committed to responsible and transparent external sharing of clinical trial data to promote scientific and medical advancement. Agios complies with all applicable regulatory requirements regarding clinical trial disclosure by posting results directly to clinical trial registries and registering all Agios-sponsored clinical trials and interventional trials conducted in patients (Phases 1-4) on www.clinicaltrials.gov and www.clinicaltrialregister.eu. Agios protects confidential patient information and Agios-specific sensitive information in order to ensure patient privacy and the protection of proprietary information.
Data Sharing with Researchers:
Agios is committed to sharing clinical trial data with scientific researchers in the interest of advancing public health. Agios will consider external requests from qualified researchers for data derived from completed Agios-sponsored interventional clinical trials conducted in patients for products and indications submitted to and approved in both the United States and the European Union. Agios will not review external requests for data derived from clinical trials that are not yet completed or are not sponsored by Agios such as investigator-sponsored trials.
Researchers may request data by downloading and completing a request form and emailing it to email@example.com.
Each request will be reviewed and evaluated by Agios based on:
- data requested
- rationale for the proposed research
- statistical analysis plan
- publication and posting plan
- qualifications and experience of requestor or intended researcher(s) and any potential conflicts of interests
source of any research funding
The qualified researcher(s) are then responsible for obtaining any required approvals for conducting the research (for example, from ethics committees, institutional review boards, relevant research institutions or funding bodies).
If Agios agrees to the release of clinical trial data for research purposes, the requestor will be required to sign a data sharing agreement prior to the release of any data. Agios will then provide access to the agreed upon data sets and documents such as the clinical study report synopsis, protocol and statistical analysis plan.