Early Access to GLIOVAC/ERC1671/SITOIGANAP
Despite best efforts, it is not possible for all patients to participate in clinical trials. For that reason, ERC has established an early access program in a number of regions.
In the U.S., patients interested in seeking Right-to-Try (RTT) access to an ERC investigational product should talk to their physician. An eligible physician may request access to one of ERC’s investigational products by completing the ERC Right to Try Request Form. For more information please contact Chris Beardmore at firstname.lastname@example.org
Patients interested in seeking early access to ERC products may also be approved under the U.S. Food and Drug Administration’s Expanded Access program. Cases may be approved to proceed under Expanded access when ERC products are used in combination with other investigational products, when the case is serious but not life-threatening or at the request of the patient’s treating physician. For more information, please contact ERC at email@example.com
In Australia, patients interested in seeking early access to an ERC investigational product under Category A of the TGA Special Access Scheme (SAS) should talk to their physician. An eligible physician may request access to one of ERC’s investigational products by completing the ERC Special Access Scheme Request Form.
Requests for further information about how to apply for early access or determine qualifications and capabilities required to administer ERC investigational product can be made to firstname.lastname@example.org
ERC is also willing to consider early access requests outside of these regions.
ERC typically will acknowledge receipt of a request, with required medical documentation, within three business days. ERC professionals will carefully consider requests taking into account access to open and accruing clinical trials, the serious/life-threatening nature of the disease, biological rational or clinical data supporting potential benefit medical appropriateness, and applicable laws and regulatory requirements. All physicians who receive ERC investigational product through RTT or SAS are required to comply with all applicable laws and regulations, and contractual conditions, including those related to safety reporting.
ERC’s Right to Try Policy can be found here.
ERC’s Special Access Scheme Policy can be found here.