If You Can’t Join a Clinical Trial: Compassionate Use
If you have cancer and can't join a clinical trial, you may still be able to access experimental treatments or investigational drugs. Compassionate use, through expanded access programs (EAPs) or the Right to Try Act, can help you get experimental treatments when no other cancer therapies are available.
What is compassionate use?
Compassionate use is a way for someone with a serious or life-threatening illness to get access to a new treatment that has not been approved yet when no other treatments are available. It can give you access to treatments being tested in clinical trials even if you are not able to be part of the trial.
There are 2 ways to access treatments through compassionate use:
- Expanded access programs (EAPs)
- Right to Try Act
Expanded access programs (EAPs)
Expanded access programs (EAPs) can provide access to experimental treatments with approval from your doctor, the company that makes the treatment, and the US Food and Drug Administration (FDA).
Who is eligible?
EAPs are usually for people who:
- Have a serious or life-threatening condition
- Are not eligible for any clinical trial testing the treatment
- Have no other comparable treatment options
- Are likely to have benefits that outweigh the risks involved
How to apply for EAP
- Talk with your doctor to find a treatment you want to try.
- Your doctor will ask the company who makes the treatment if they are willing to provide it.
- If the company agrees, your doctor will contact the FDA’s Center for Drug Evaluation and Research (CDER) at 1-301-796-3400 or fda.gov/drugs or the after-hours FDA Emergency Call Center at 1-866-300-4374 (toll free).
- Your doctor and/or the company must submit forms to the FDA.
The FDA accepts applications for EAPs every day of the week. It usually takes 4 days to process a non-emergency request, and less than 1 day to process an emergency request.
The FDA approves most of these requests but may require changes in the dose of the treatment or changes to safety monitoring.
If your application is approved
- Your doctor will explain the risks and benefits of the treatment so that you can provide your informed consent.
- The company will provide the treatment.
- Your treatment can begin.
See the FDA's information on EAPs to learn more.
Right to Try Act
The Right to Try Act is a federal law passed in 2018 to help people access unapproved treatments without going through the FDA. It allows your doctor to request an experimental treatment directly from the company that makes it, but it doesn’t require the company to provide the treatment.
Bypassing the FDA may mean there’s less guidance for how the treatment is being given.
Who is eligible?
To be eligible for Right to Try, a person must:
- Be diagnosed with a life-threatening disease or condition
- Have tried all approved treatment options for the disease or condition
- Have a doctor certify that they are unable to participate in a clinical trial for the investigational treatment
- Give written informed consent that they understand the risks of taking the investigational treatment
In addition, the treatment must have already been through a phase I clinical trial.
How to request Right to Try access
Your doctor will need to contact the company that makes the treatment to find out if it’s available and if you are eligible to get it. You can also contact the company yourself to find this information, but the request for the treatment will need to come from your doctor.
Not all requests are approved. For example, a company may deny access if:
- You don’t meet the criteria spelled out in the law.
- They can’t make enough of the treatment for everyone requesting it.
If your request is approved
- The company that makes the treatment will work directly with your doctor on your treatment plan.
- Your doctor will explain the risks and benefits of the treatment to you so that you can provide your informed consent.
- The company will provide the treatment.
- Your treatment can begin.
To learn more, see the FDA's information about Right to Try.
What is the difference between EAP and Right to Try?
Both EAP and Right to Try provide similar access to experimental treatments. They both:
- Have the same requirements for eligibility
- Must be requested by a licensed doctor
- Can be denied by the drug company
- Are not required to be covered by insurance
The main difference between compassionate use access through EAPs and Right to Try is that the FDA is involved in EAPs. This means the application process is more complicated for an EAP, but there is also more safety oversight.
Are all investigational medical products available for compassionate use?
No. Companies are not required to supply their treatments through compassionate use, and each company has different policies. Sometimes, there may only be small amounts of a treatment available for compassionate use, or companies might only have enough for use in clinical trials.
However, laws do require all companies to publicly post contact information for compassionate use requests.
Is compassionate use covered by insurance?
Most insurance companies will not pay for the costs of investigational treatments with compassionate use. Some companies will supply a treatment through compassionate use for free, but others might charge patients. There might also be other costs that aren’t covered, such as the clinic's charges for giving the treatment and monitoring your response.
What should I ask my doctor about compassionate use?
Here are some questions you might want to ask if you and your doctor are discussing compassionate use:
- Are there any approved treatments that I haven’t tried?
- Is there any evidence to support the use of this treatment for my type of cancer?
- What are the known risks and benefits of this treatment?
- Will the company give me the treatment for free? If not, what costs will I have to pay to get the treatment? Will my insurance cover any costs?
- Should we consider an EAP or a Right to Try path? What are the pros and cons of each?
- What will we have to do to get access to this treatment?
- How long do you think it will take for me to get access to this treatment?
- Written by
- References
Developed by the American Cancer Society medical and editorial content team with medical review and contribution by the American Society of Clinical Oncology (ASCO).
Congress.gov. S.204: Right to Try Act of 2017. Accessed at https://www.congress.gov/bill/115th-congress/senate-bill/204 on April 24, 2025.
U.S. Dept of Health and Human Services. About the Affordable Care Act. HHS.gov. Updated March 17, 2022. Accessed at https://www.hhs.gov/healthcare/about-the-aca/index.html on April 24, 2025.
U.S. Food and Drug Administration (FDA). Expanded access. Fda.gov. Updated February 28, 2024. Accessed at https://www.fda.gov/news-events/public-health-focus/expanded-access on April 24, 2025.
U.S. Food and Drug Administration (FDA). Right to try. Fda.gov. Updated December 12, 2024. Accessed at https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try on April 24, 2025.
Last Revised: June 3, 2025
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