Expanded access trial

Expanded Access Trial is a term used in the field of clinical research to refer to the use of an investigational drug outside of a clinical trial. This is typically done when a patient has a serious or life-threatening disease or condition and there are no comparable or satisfactory therapies available.

Overview

Expanded Access Trials, also known as Compassionate Use trials, are designed to provide potentially life-saving experimental treatments to patients who are unable to participate in randomized controlled clinical trials. The primary goal of these trials is to provide access to treatments for patients who have exhausted all other treatment options.

Eligibility

To be eligible for an Expanded Access Trial, a patient must typically meet the following criteria:

• The patient has a serious or life-threatening disease or condition.
• The patient has exhausted all other treatment options.
• The patient is unable to participate in a randomized controlled clinical trial.

Process

The process for obtaining access to an investigational drug through an Expanded Access Trial typically involves the following steps:

1. The patient's physician submits a request to the drug manufacturer.
2. The drug manufacturer agrees to provide the drug.
3. The patient's physician submits an application to the FDA.
4. The FDA reviews the application and, if approved, the patient can begin treatment.

Risks and Benefits

While Expanded Access Trials can provide access to potentially life-saving treatments, they also come with risks. These can include side effects from the investigational drug, as well as the possibility that the drug may not be effective.

On the other hand, the benefits of Expanded Access Trials can be significant. For patients with no other treatment options, these trials can provide a last chance at treatment. Additionally, data collected from Expanded Access Trials can contribute to the overall body of knowledge about a drug and its potential effectiveness.

See Also

• Clinical Trial
• Compassionate Use
• FDA

Expanded access trial Resources
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