Access to Care Statement
Access to Clinical Trials
We understand the urgency felt by patients and their families facing a serious or immediately life-threatening disease when there are no standard treatment options available or all treatment options have been exhausted. In the future, Corvidia Therapeutics may consider providing access to our investigational medicines to patients with a serious or immediately life-threatening disease and for whom participation in one of our ongoing clinical trials is not possible. Our goal is to help as many patients as possible while maintaining our primary focus on moving our investigational medicines through clinical trials and ultimately toward regulatory approvals.
Compassionate Care & Expanded Access Requests
We at Corvidia Therapeutics are committed to developing our investigational medicines for cardio-renal disease. Currently, we are not evaluating requests for compassionate access. If you have questions regarding the status of our development programs or regarding our criteria for evaluating requests for compassionate access, please contact us at email@example.com.
In the future, we may consider individual compassionate access requests for our investigational medicines that meet the criteria outlined below. For our investigational medicines that are in later stages of development, we may also consider opening broader expanded access clinical programs. The type of compassionate access or expanded access program can vary from country to country for many reasons, including national and local laws as well as health authority requirements. This may be the case even for the same investigational medicine. However, all requests for access to our investigational medicines outside of clinical trials must meet the following criteria in order to be considered.
– The patient must have a serious or immediately life-threatening disease for which there are no standard treatment options available or all treatment options have been exhausted;
– The patient must not be eligible for ongoing clinical trials of the investigational medicine or must not be physically able to travel to a clinical trial site;
– The investigational medicine must be in active clinical development in the disease with sufficient clinical data available to suggest that the drug may provide therapeutic benefit in that disease;
– Requests for access to our investigational medicines must be made by a qualified physician who agrees to directly supervise treatment of the patient, and we will acknowledge receipt of such requests within five business days. The physician making the request must have made a determination that the probable risk to the patient from the investigational medicine is not greater than the probable risk from the disease. We will work with the patient’s physician to provide him or her with available information about the investigational medicine, at the time of the request, to enable this assessment;
– Providing the investigational medicine will not compromise or interfere with its clinical development, including the initiation, conduct or completion of clinical studies; and
– There must be enough investigational medicine available for the requested use after ensuring adequate supply for ongoing and planned clinical trials and other supporting work required for regulatory submissions.
Because we believe it is important to have clinical data regarding the potential benefit/risk of an investigational medicine in a particular disease, we are not supporting requests for compassionate access to our investigational medicines in diseases that we are not actively studying in clinical trials.
While we cannot guarantee compassionate or expanded access to our investigational medicines, Corvidia Therapeutics will continuously evaluate all our clinical programs in relation to these criteria and in the future will evaluate all requests individually. Appropriate health authorities, such as the FDA in the United States, and the Institutional Review Board (IRB) or Ethics Committee (EC) at the patient’s treating hospital or clinic must also review and approve the proposed use of the investigational medicine by the patient before Corvidia Therapeutics can provide it. In addition, the submitting physician must agree to comply with regulatory obligations, including obtaining patient informed consent, patient monitoring and safety reporting.
If you have a question regarding a request for access to one of investigational medicines that meets the above criteria, please send your inquiry to firstname.lastname@example.org.
You can learn more about our ongoing clinical trials by searching for “Corvidia Therapeutics” or the name of the investigational medicine on http://www.nih.gov/health/clinicaltrials/index.htm.
Corvidia reserves the right to revise this expanded access policy at any time. The posting of this policy does not guarantee access to any investigational medicine by any patient.