Navigating care
The short answer on waiting for a clinical trial that isn't open yet
This is a real trap: the next standard treatment can make you ineligible for the trial you're waiting on. Some families have bridged the gap through expanded access, federal Right to Try or, now, Montana's new state law. None of these is guaranteed, so the advice is to start early, pursue several at once and keep your oncologist leading.
What to know about waiting for a clinical trial that isn't open yet
- Two clocks are running: the trial's opening date and your cancer.
- Every pathway needs the company to say yes. The FDA, a state law or a doctor can't make a company supply its drug.
- Your doctor matters. A request from an investigator on the upcoming trial carries extra weight.
- Montana's law is new and untested. Its rules took effect in July 2026, and its first approved treatment is not for cancer.
- Run paths in parallel. Waiting for one to fail before starting the next is usually too slow.
Why can the next standard treatment rule you out of a clinical trial?
A trial of an investigational drug looks like a good fit. But it hasn't opened yet, or its opening has been delayed. Meanwhile your current treatment has stopped working, and the next standard treatment would disqualify you from the trial. Future of Cancer Care Today calls this a common barrier: trials take time to open, and cancer doesn't wait.
What pathways exist when the clinical trial you need hasn't opened yet?
Single-patient expanded access (compassionate use). Your doctor asks the FDA using Form 3926, and the company must agree to supply the drug. The FDA says it allows over 99% of these requests to proceed. Our guide to asking a drug company for an experimental drug covers this in detail.
Federal Right to Try. A 2018 law that lets eligible patients ask a company directly for drugs that have finished a Phase 1 trial and are still in development, without FDA review of the request. The company must still agree.
Montana's state law. More on this below.
How do you get ready while waiting for a clinical trial to open?
Before approaching a company or a state program, the guide suggests having:
A treating doctor willing to sign Form 3926, or to prescribe under a state program.
A one-page clinical brief: diagnosis, previous treatments, current status and the scientific reason for this drug.
Proof of the timing trap: where and when the trial plans to open, the eligibility criteria you meet today and the standard next treatment that would exclude you.
A check of the company's expanded access policy on the Reagan-Udall Foundation's Expanded Access Navigator. No posted policy doesn't mean no program.
A plan for collecting tissue and blood samples. Offering this data to the company from the start can change how it sees the request.
What does Montana's new law mean for access to experimental treatment?
In 2025, Montana passed Senate Bill 535, which lets licensed clinics in the state offer certain experimental treatments under physician supervision once a treatment plan has passed a safety review. A treatment must have completed a Phase 1 safety trial, and its protocol must be approved by a Montana-licensed review board. Approval covers the treatment, not each patient, so once a protocol is approved, eligible patients can get it through a licensed clinic.
Where it stands. The state's rules took effect in July 2026, according to MIT Technology Review. The first review board is a private, five-member panel that charges companies $12,500 per application. In September, Medical Daily reported that the first treatment had been authorized, for hearing loss. We haven't seen reports of a cancer treatment approved under the law yet.
What's different. Unlike federal Right to Try, Montana doesn't require the patient to be terminally ill. Companies set their own prices, and insurance is unlikely to pay. Critics, including Harvard's Aaron Kesselheim, have raised concerns about selling unproven treatments without FDA oversight, and the FDA has not said how it will view data from these treatments.
What families can do. Ask your oncologist whether a company with a relevant drug is pursuing a Montana protocol, and whether treatment at a Montana clinic could fit your plan. A company has to apply first; a patient can't start the process alone.
Why do drug companies hesitate to give early access, and how can you help?
Companies usually say no for practical reasons, not personal ones. The guide lists four, with ways to address each:
Side effects still get reported and can affect the drug's record. Help by showing clearly why you match the patients the drug was designed for.
Your results don't count toward the trial. Help by offering to collect and share tissue and blood data the company can learn from.
It's extra work for their staff. Help by arranging the doctor, infusion site and sample logistics before you ask.
They worry about setting a precedent. Help by anchoring the request in something specific about your case, not a broad argument for access.
What steps have helped families get early access to a trial drug?
Use an investigator from the upcoming trial as your doctor. They already know the protocol and the company's team.
Find the right senior contact, usually in Medical Affairs or clinical leadership, not the CEO.
Start with the smallest ask: a doctor-to-doctor call or a one-page brief before any formal request.
Bring an offer with the ask: sample collection, data sharing, willingness to travel or, where allowed, to pay for the drug.
Move in parallel: expanded access, Right to Try, state programs, patient access organizations and the trial itself once it opens. Some companies that decline in the U.S. allow access through partners in Australia, the EU, the UK or Israel.
Questions about clinical trials to talk through with your oncologist
- When is the trial expected to open, and at which sites?
- Which next treatment would make me ineligible, and how long can we safely wait?
- Could an investigator on the trial request access for me now?
- Would you file a single-patient expanded access request?
- Can we collect tissue and blood samples to offer the company?
- Which other paths should we pursue at the same time?
From the Toolkit
- Questions about treatment and clinical trials Printable
- Guides for complicated care Toolkit
- Building your care team Guide
Sources
Future of Cancer Care Today, Sijbrandij Foundation, Bridging to a Clinical Trial That Hasn't Opened Yet: A guide for patients and families (2026)
U.S. Food and Drug Administration, Physicians: How to Request Single Patient Expanded Access
U.S. Food and Drug Administration, Right to Try
Montana Legislature, Senate Bill 535 (2025)
MIT Technology Review, Montana's plan to become an experimental medical hub just pushed forward (July 30, 2026)
Medical Daily, Montana's new rules let licensed clinics sell drugs that cleared only Phase 1 safety testing (September 2026)
Reagan-Udall Foundation, Expanded Access Navigator
Babette is an independent media and education company, not a medical provider. This article explains common experiences and options; it is not advice for your situation. All decisions about your care belong to you and your doctor.
