Terns believes the best way for patients to access investigational products is through participation in a clinical trial. To find out more about participating in a clinical trial, please visit www.clinicaltrials.gov.
However, in certain cases in which a patient does not qualify for a clinical trial, a patient may seek “expanded access” (also known as “compassionate use”) to gain access to investigational products outside the clinical trial setting and prior to regulatory approval.
In general, Terns is not able to provide expanded access to an investigational product that has not yet been studied for a disease or condition. As clinical trials progress and we learn more about how our investigational products perform in patients, we will periodically re-evaluate the potential for expanded access. For more information about our investigational products, see our pipeline page.
When reviewing expanded access requests for investigational products outside of a clinical trial, Terns will consider granting access only if all of the following criteria are met:
The patient has a serious or life-threatening condition with no available satisfactory alternative therapy.
Documented failure to meet eligibility criteria for any applicable ongoing clinical trials, or inability to participate in any ongoing clinical trials.
The patient has a disease for which there is sufficient evidence of a potential benefit from use of the investigational medicine and the benefit outweighs the collective potential risks for the patient and the risks are not unreasonable in the context of the disease to be treated.
The expanded access will not interfere with the company’s ability to complete clinical trials in a timely fashion; nor will it otherwise delay the overall development program to support registration of the product.
There is an adequate supply of the investigational product to meet the needs of the expanded access request without impairing ongoing clinical trials.
A qualified physician or healthcare providing medical care for the individual (HCP) must initiate the request and be experienced with the disease and drug class, with IND trial experience and familiar or willing to work with the local regulatory authorities for single patient use.
There is a regulatory mechanism in the country or region to support expanded access and provision of the investigational product in response to the expanded access request will be compliant with local regulations and laws
There is a plan by Terns to market the product in the country or region from which expanded access was requested.
Requests for access must be made by a licensed physician in a communication that explains how all the criteria above are met. Requests should be submitted to MedInfo@ternspharma.com. Requests should include sufficient supporting detail to enable Terns to evaluate the expanded access request.
Terns will acknowledge receipt of any expanded access questions or requests within seven (7) business days of receipt. All eligible requests will be evaluated by a review committee in an objective and fair manner.
As authorized by the 21st Century Cures Act, Terns may revise this expanded access policy at any time. Additionally, the posting of this policy by Terns shall not serve as a guarantee of access to any specific investigational drug by any individual patient