When Clinical Trials Aren’t an Option
For many patients with serious or life-threatening illnesses, clinical trials can feel like the final hope—the one chance to try something new after standard treatments have stopped working. Trials offer access to experimental therapies that might not be available anywhere else, and they represent the cutting edge of science. But despite their promise, not everyone qualifies.
In fact, the majority of patients who search for trials are ultimately deemed ineligible. The reasons can vary. A trial might only accept patients in a certain age range or require a very specific stage of illness. Some trials exclude patients with other health conditions, even if those conditions are stable. Others require participants to be physically located near a research site or available for frequent clinic visits, which can be difficult for people living in rural areas or those with limited mobility.
These strict inclusion and exclusion criteria are not arbitrary—they’re designed to ensure the safety of participants and the integrity of the data. But from a patient’s perspective, they can feel like locked doors. Being told you can’t join a trial, especially when you’ve run out of other treatment options, is emotionally devastating.
This is where Expanded Access Programs come in. They’re not widely talked about, but for the right patient, they can make all the difference.
What Is an Expanded Access Program?
An Expanded Access Program (EAP) is a regulatory pathway that allows patients to access an investigational medical product outside of a clinical trial. These products can include drugs, biologics, or medical devices that are still being studied and haven’t yet been approved for general use.
These programs are intended for patients facing life-threatening or severely debilitating conditions who have no comparable alternatives. To qualify:
- The patient must be ineligible for ongoing clinical trials.
- Their physician must believe the potential benefits outweigh the risks.
- The drug or device manufacturer must agree to provide the product.
Once those pieces are in place, a formal application is submitted to the appropriate regulatory body—like Health Canada or the FDA in the United States. The review process is typically faster than standard approvals, especially for single-patient cases, but still requires oversight to ensure safety.
Think of it as a way to bring tomorrow’s treatments to today’s patients—when no other viable path exists.
Why Don’t More People Know About This?
Despite its importance, expanded access remains one of the most underutilized and least understood options in medicine today. Many patients and caregivers have never even heard of compassionate use. Even among healthcare providers, awareness can vary widely.
Part of the problem is that Expanded Access Programs are not centralized. There’s no public registry listing all EAPs. Some are handled informally on a case-by-case basis, while others are only offered by certain companies or institutions. It’s not uncommon for a drug to be available under expanded access in one region but completely inaccessible in another.
This lack of visibility means patients often have to rely on their doctors to know whether an EAP is an option—and many physicians, especially those outside academic centers, may not be familiar with the process. Even when they are, navigating the paperwork and approvals can be time-consuming and confusing.
The result? Many patients never find out whether they could have qualified for expanded access. And those who do may struggle to navigate the complex path alone.
How MyTrials.ai Helps Patients Explore All Options
At MyTrials.ai, we believe that patients deserve transparency. No one should miss out on a potential treatment just because they didn’t know to ask. That’s why we’ve built our platform not only to match patients to clinical trials, but to surface alternative pathways—including compassionate use options that are often overlooked.
When a patient searches our platform, we start by trying to match them with ongoing trials based on their condition, location, and medical history. But we don’t stop there. If a patient doesn’t qualify for a trial, or if there’s no nearby trial site, our system begins to flag investigational treatments that may be accessible through other channels—like expanded access programs or named patient use policies.
We also aim to bridge the communication gap between patients, physicians, and sponsors. Through educational content, FAQs, and built-in prompts, we help patients understand when it’s appropriate to ask their doctor about applying for an EAP. We’re also working on tools that help physicians navigate the administrative process, making it easier for them to support their patients.
And because we partner with clinical research organizations (CROs), trial sponsors, and regulatory experts, we’re able to stay up-to-date on which companies are open to expanded access requests—even if those details aren’t publicly listed. Our goal is to give every patient a fighting chance by making every option visible.
A Pathway Rooted in Compassion and Urgency
Expanded Access Programs are not a replacement for clinical trials—but they are a critical safety net. They exist because sometimes, patients can’t wait for a trial to open or for years of regulatory review. In these cases, compassionate use becomes a matter of urgency, not just hope.
Of course, there are limitations. Not all investigational treatments are available through EAPs. Some companies don’t have the resources or may worry about how expanded access could impact regulatory timelines. But increasingly, public pressure and new legislation—like the Right to Try laws in the U.S.—are pushing the system to become more responsive and humane.
Even when a patient can’t access a treatment, just knowing expanded access exists shifts the mindset. It changes the narrative from “There’s nothing left” to “Let’s explore every possibility.”
A Future Where Every Door Is Open
At the heart of expanded access is a simple idea: no one should be left behind. Whether it’s a child with a rare disease or an adult in the final stages of cancer, patients deserve more than a closed door when clinical trials aren’t an option.
That’s why MyTrials.ai is building more than a matching engine. We’re building a patient-centered ecosystem—one where clinical trials, expanded access, off-label treatments, and regulatory updates are all searchable, transparent, and actionable.
Hope shouldn’t depend on knowing the right medical jargon. It should come from a system designed to inform, support, and empower.
We’re building that system—one patient at a time.
If you or someone you love is running out of options, visit MyTrials.ai to explore what’s possible—even beyond clinical trials.