AlloVir policy on providing expanded access to investigational drugs
AlloVir is committed to developing safe and effective medicines and treatments for patients worldwide. Before marketing drugs to patients, AlloVir is responsible for conducting clinical trials involving research participants to determine whether investigational drugs are safe and effective for treating a specific disease or condition. AlloVir designs and conducts clinical trials to generate valid scientific evidence, while protecting the rights and welfare of research participants. To the extent required or allowed by applicable law, regulations and, as applicable, patient consent, AlloVir intends to use the clinical data gathered from the Expanded Access Program for internal purposes, regulatory submission purposes, or reimbursement purposes.
Enrolling in a clinical trial is the most common way that persons who seek access to an investigational drug may receive that drug, and AlloVir’s clinical studies should be the primary route by which patients receive access to AlloVir’s investigational drug(s). In certain cases, however, a patient with a serious or life-threatening disease or condition may not be eligible to enroll in a clinical study sponsored by AlloVir, or an AlloVir clinical study may not be available or the patient may lack feasible access to a clinical study, but the patient and the patient's physician believe the patient could potentially benefit from access to the investigational drug before it is approved by a regulatory agency. In this case, the patient and the patient's physician may seek to obtain the investigational product outside of a clinical study, by using a process commonly referred to as “expanded access” or “compassionate use.” In those circumstances, when no satisfactory alternatives are available and to the extent compliant with all applicable laws, AlloVir may provide a physician with access to an investigational drug outside of a clinical trial to treat a particular patient or a group of patients with that investigational drug. The decision criteria AlloVir applies when considering such requests are set forth below. When AlloVir makes an investigational drug available to a patient and his/her physician who requests the drug, AlloVir is not representing or promising that the investigational drug is safe or efficacious to treat, diagnose, or monitor the patient's illness or medical condition.
In general, AlloVir will consider making investigational drug(s) available, for expanded access use for individual patients, only in response to a request from a licensed physician (a "Program Request"). The determination to grant or deny a Program Request is in the sole discretion of AlloVir. It is important for patients and physicians to understand that AlloVir does not guarantee that it can or will approve any Program Requests for investigational drugs. If a Program Request is granted, to the extent allowed by applicable law, regulations and, as applicable, patient consent, AlloVir will require the physician to ensure that AlloVir receives clinical data that are obtained as a result of the physician’s administration of the investigational product. AlloVir's decision to grant or deny a Program Request may be modified or reversed by AlloVir at any time, and is subject to AlloVir's continuing evaluation of safety and effectiveness data about the investigational drug, as well as other considerations related to inventory, manufacturing, and clinical development programs. AlloVir may revise this Policy at any time.
In general, AlloVir will consider whether:
- The requesting patient has a serious or life-threatening disease or condition, as represented by the requesting physician and otherwise confirmed through medical records
- The patient is ineligible or otherwise unable to participate in any clinical study of the AlloVir investigational drug or of any other investigational drug for that patient's condition
- The nature of the disease or condition of the requesting patient warrants or lends itself to intervention
- There are alternative treatment options available and/or whether such treatment options have been used
- Clinical data are available to assess the potential benefits and risks in providing the investigational drug for treatment
- The potential benefits to the patient justify the potential risks of the treatment use, and the risks are not unreasonable in the context of the disease or condition to be treated or the patient’s current state
- It is reasonable and appropriate, from a clinical and scientific perspective, to use the investigational drug for this particular patient
- The use of the investigational drug will be monitored and controlled appropriately and adequately by a licensed physician
- The licensed physician under whose control the investigational drug will be administered is sufficiently qualified in terms of experience and credentials, to administer the investigational drug in a safe manner
- With the possible granting of the request for the investigational drug, there would remain sufficient supply of investigational drug for ongoing and planned clinical trials
- The granting of the request would affect or interfere with the initiation, conduct, or completion of clinical trials, or otherwise compromise the potential development and/or commercialization of the investigational drug
- The investigational drug is part of an active clinical development program at AlloVir
- An adequate supply and distribution logistics process exists for the investigational drug
- AlloVir is able to reach agreement with the physician and/or the applicable site regarding an appropriate expanded access agreement satisfactory to AlloVir
- The Program Request, and AlloVir's grant of the request, would be compliant with applicable local, state/provincial, and federal/national laws and regulations, as well as industry standards
Program Requests directed to AlloVir must be received in writing, must be signed and submitted by a licensed physician who is in a treatment relationship with the patient for whom the investigational drug is being requested, and must be sent to email@example.com. AlloVir may require up to 5 business days to acknowledge receipt of the Program Request. While AlloVir intends to provide a written response to all Program Requests in a timely manner, certain factors which may affect the length of the review period include, but are not limited to, obtaining permission from regulatory authorities, the need for additional information from the requestor, or other factors beyond AlloVir’s control. AlloVir recognizes that the decision to grant or deny a Program Request is complex. AlloVir commits to: (i) conducting a clinical review of all requests, (ii) deciding each request in an equitable and fair manner, and (iii) using the available scientific and clinical evidence in making each decision.