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When You Don’t Qualify for a Clinical Trial: Expanded Access Might Help

When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial. We de-bunked common myths in this blog post, talking about the benefits of considering clinical trials, in efforts to shift the conversation from clinical trials being thought of as a “last option,” to figuring out if clinical trials may actually provide the best care and treatment you need.

If your health care team has identified a clinical trial that might be a good treatment option for you, but you do not qualify for clinical trial, there may still be a way to get access to the treatment being tested in the clinical trial.

What is Expanded Access?

The Food and Drug Administration (FDA) has an Expanded Access Program, which helps connect patients to investigational treatments outside of a clinical trial. Click here for more information about this program, which is often referred to as the Compassionate Use program.

Recently, the Reagan-Udall Foundation for the FDA announced the Expanded Access Navigator (the EA Navigator), to help healthcare providers, patients and caregivers quickly identify investigational drugs, and streamline the physician/drug company communication process.

In an FDA News Release, Acting FDA Commissioner Ned Sharpless, M.D. said, “when [a clinical trial] is not an option, we support Expanded Access and are exploring ways to make it easier for patients, their families and health care professionals to understand the process and how to access investigational therapies.”

How does the Expanded Access Navigator program work?

Instead of making patients spend valuable time researching endless resources for investigational therapies, the EA Navigator provides an online resource for individuals to do all their research in one place.

Highlights of this online resource include:

  • Search and filter the EA Navigator by disease, drug or company to retrieve detailed descriptions and eligibility criteria for expanded access programs offered by pharmaceutical companies
  • Medical terminology can be complicated sometimes, so the EA Navigator makes searching easy, with results that will show a variety of options, even if the user is unsure of spelling.
  • The EA Navigator also provides resources not approved by the FDA, in order to offer other investigational therapy resources to patients who have exhausted all other treatments and do not qualify for clinical trials

I’m curious about Clinical Trials. Where else can I find resources on Clinical Trials?

Triage Cancer provides a variety of resources and materials to help you understand and access clinical trials:

Samantha Skelton
ss@triagecancer.org