The most efficient and ethical manner for a patient to access a medicine prior to it being approved by regulatory authorities is to enroll in a clinical trial. Well-designed and conducted clinical trials are essential in bringing new treatments to patients. People who choose to participate in clinical trials play a critical role in developing new medicines where the ultimate goal is the securing of regulatory approval enabling the medicine to be available to as many patients as possible.
The sponsor of a clinical trial has an ethical responsibility to protect the rights and safety of clinical trial participants and ensure the integrity of the trials conducted. Individuals participating in Idera’s clinical trials are provided with the treatment being tested. The purpose of these trials is to discover whether the treatment is safe and effective. Until the regulatory authority has made this decision on the safety and efficacy, the treatment remains experimental and is not generally available to patients. However, patients who are not part of these trials and meet certain criteria (see below) can request access through their physician to the investigational treatment.
Expanded Access Programs
Idera recognizes that in certain circumstances, enrollment in a controlled clinical trial may not be always be possible for patients facing serious life-threatening conditions and access to investigational medicines may be sought outside of a clinical trial. These situations are typically referred to as expanded access programs (EAP), but are also called compassionate use or early access.
If you are not eligible for an open clinical trial, or if no appropriate clinical trials exist, and if your treating physician believes that an EAP may be the best or only treatment option for you, please ask your doctor to contact Idera on your behalf at 1-877-888-6550 ext. 2 or firstname.lastname@example.org
How Requests are Evaluated
When a request is received for expanded access, Idera will acknowledge the request within 5 business days and will evaluate all requests based solely on clinical evidence and guided by the following principles:
- The patient’s disease progression and condition are considered life-threatening.
- All attempts to identify and qualify for a clinical trial have been unsuccessful.
- An adequate set of safety and efficacy data is available (usually after completion of Phase 2 studies), including an established dose.
- Granting access would not jeopardize ongoing clinical trials required for approval or cause a shortage of product needed for enrolled patients to complete a trial.
- A request for access was unsolicited by Idera or any other organization and received in writing from a treating physician.
- Potential benefits to the patient seeking access to the investigational medicine must outweigh the collective potential risks to the patient.
How Decisions are Made
Idera is committed to a fair and impartial evaluation of each request for access to our investigational medicines programs (IMPs). All IMPs are subject to local regulatory and ethical reviews/approvals, patient consent, and treating physician agreement with any safety monitoring that may be necessary.
To ensure a fair review of EAP requests, decisions will be based on the above criteria. Requests will be considered on a first come first served basis for all patients dependent on drug availability.
Idera cannot make a guarantee that an EAP will be available, and, even if an EAP is offered, Idera cannot make a guarantee that the investigational medicine will be available to a particular patient.
All decisions are based on clinical circumstances. Outcomes of expanded access evaluations will be communicated to the treating physician in writing.